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COALITION OF SILICONE SURVIVORS
P. O. Box 129 Broomfield, CO 80038-0129
Lynda Roth - (970) 506-9288 e-mail: coss@privatei.com
Website: www.siliconesurvivors.net

August1.2004

Dear Silicone Survivors and Friends:

This will be our last newsletter. The day has come, the Dow Bankruptcy Settlement is in effect. June 1st is the effective date. There is much to know about this and I hope you all have sources of information. We will post websites and helpful information under legal information.

The quote heard round the country: ``It's a black day for the women of this country when our government doesn't protect us from such dangerous products,'' said Lynda Roth of Greeley, Colo., who heads the Coalition of SiliconeSurvivors. Seems that of every thing I said to AP (Associated Press) at the FDA Hearings on Silicone Implants, this is the quote they loved. It hit thousands of papers around the country. I assure you that I said much more newsworthy things, but they did not see fit to quote those. In any case, at least this time, the FDA chose not to put the silicone breast implants back on the market. Make no mistake about it, the manufacturers will be back to try again! The fight is NOT over.

LEGAL INFORMATION: See below article for information on how to contact the Tort Claimants Committee and the Dow Settlement Facility:

By now, most of you know that the Nevada Claimants dropped their appeal of the Dow Bankruptcy and allowed it to go forward. I suspect they knew they would never win this one, as I have thought all along. But, it did allow the settlement to go forward, and many are grateful for that.

Checks to be processed for breast implant victims starting June 1st, LOS ANGELES, June 1 (PRNewswire): June 1st is the effective date in the Dow Corning bankruptcy, finally allowing injured people's claims to be processed. The court-appointed claims administrator for the $2.35 billion fund said that thousands of letters will go out June 1st and that the first checks should be mailed June 15th. The case started in 1995 when the former breast implant manufacturer filed for bankruptcy in the face of thousands of claims. The details of the company's bankruptcy plan were confirmed in 1999, but numerous appeals stalled the implementation

MAY 21, 2004 - JUDGE AUTHORIZES PAYMENTS TO CLAIMANTS: On May 20, 2004, Judge Denise Page Hood signed an Order authorizing the payment of First Priority Payments of Allowed Claims beginning on the Effective Date (June 1) and continuing until further order of the Court. This means that the Settlement Facility offices are now authorized to begin issuing payments to those claimants whose claims have been submitted and who have acceptable proof. For more information about the status of your claim, you can contact the Claims Assistance Program by visiting their website at www.dcsettlement.com or by calling toll free to 1-866-874-6099. (I have heard that women are already receiving payments, so this is good).

MAY 17, 2004 - CLAIMANTS' ADVISORY COMMITTEE APPOINTED: On May 14, 2004 the Claimants Advisory Committee ("CAC") was appointed pursuant to the Amended Plan of Reorganization. The Amended Joint Plan of Reorganization created this committee to assist in all aspects of implementing the Plan including advising and assisting the Settlement Facility, Claims Administrator, the Finance Committee and the Litigation Facility on all matters of mutual concern. The members of the Claimants' Advisory Committee are:
n Sybil Niden Goldrich, tort claimant, Los Angeles
n Ernest Hornsby, Esq., Dothan, Alabama
n Dianna Pendleton-Dominguez, Esq., Houston, Texas
The members of the Claimants' Advisory Committee are very knowledgeable about the Settlement Plan and have worked closely on this litigation for the past 12 or more years and specifically have worked closely with the Claims Administrator on all issues related to this case. The Tort Claimants' Committee will be dissolved as of the Effective Date. Inquiries about the Settlement Option and Litigation Option may be directed to the Claimants' Advisory Committee at: info@tortcomm.org.

One of the first things we are working on is supporting efforts to allow payments to begin to approved claimants immediately after June 1st. We are also working closely with the Claims Administrator to hold claimant meetings and educate claimants about the settlement process and their rights. As soon as the meeting scheduled is confirmed, we will post news on this website. We look forward to working with all of you and are committed to doing everything we can to make the settlement process fair, quick and as simple as possible.

Administrator's Corner: Updated: 06/01/2004 @ 8:40 AM. For more information go to: http://www.dcsettlement.com/

Dear Claimants and Counsel:
The Effective Date is here!! We are excited to be able to work with you on the processing of your claims for Settlement benefits. Now that we have reached the Effective Date, many exciting things will begin to happen. First, the Facility is mailing award letters today for all claimants who will receive checks in our first batch of payments. Second, we will also begin mailing Notification of Status letters for those of you who submitted a Valid Waiver of Opt-Out form and filed claims for settlement benefits. Please pay attention to these letters as they will trigger lines for you to respond to our requests for additional information. For those of you who have not yet waived your right to opt-out, you will be receiving a Participation Form package. This package will contain detailed information and instructions on your settlement decision. Please read this packet carefully and if you have any questions, contact Claims Assistance at 1-866-874-6099. Claims Assistance Representatives are available Monday ? Friday, from 6:00 am to 6:00 p.m. CST. They can offer assistance in seven different languages so please contact them with any questions you might have. All of you will also be receiving the latest edition of the Settlement Facility Newsletter. This contains important announcements concerning proof of manufacturer guidelines and an extensive frequently asked question section. We will also continually update the FAQ section of our website, so be sure to take a look at the latest additions to that section. Updates are marked *NEW* for quick reference.

So as you can see, there is a lot of information out there to help you with the claims submission process. Again, do not hesitate to contact Claims Assistance with any questions. We're here to help! We at the Settlement Facility look forward to working with each of you through this process. Thank you for your patience and cooperation.

MAY 10, 2004 As last reported, the Effective Date for implementing the Plan settlement and paying claims is June 1, 2004. On that date, the Settlement Facility office will mail a "Participation Form" to all Personal Injury Claimants who have not already waived their right to opt-out of the Settlement Option. You can use the Participation Form to inform the Settlement Facility of your decision to remain in the Settlement Option, opt-out of the Settlement Option to pursue your claim in court against the Litigation Facilty, or withdraw your claim from the Dow Corning bankruptcy case. Also, please remember that all deadlines to make claims or to opt-out to file a lawsuit begin to run on the Effective Date. There will be a newsletter in your Participation Form mailing that has a one-page chart of all claim deadlines that you can use for future reference.

Claims in the Settlement Option will be processed in the order that they are received. If you have not already submitted your claim forms and received a "Waiver of Opt-Out Right" form, then you must use the Participation Form to elect settlement to notify the Settlement Facility to begin processing your claim(s).

For those claimants who have signed "Waiver" forms, your claims have been or are currently being processed and, when approved, will be paid. The Claims Administrator has informed us that she has approximately 6,000 claims totaling $40 million ready for payment on June 15th. A motion to authorize payments to these claimants is currently pending and scheduled for a hearing on May 20th. We do not anticipate any opposition to this motion and fully expect that claim payments will begin in June 2004. In addition, "Notification of Status" letters will also be mailed at or near June 1, 2004 to persons who have already signed a Waiver form. Please read these carefully. If you have a "deficiency" in your claim, please note the deadline to cure the deficiency and make sure you submit your supplemental information to the Settlement Facility by that deadline.

The Claims Administrator has also informed us that additional "Frequently Asked Questions" or FAQ's that clarify settlement options have been posted to the Settlement Facility website (www.dcsettlement.com). Please review these FAQ's and continue to check the Settlement Facility site frequently for additions and information. These new FAQ's have valuable information that can assist you in preparing and submitting your claim.

JUNE 10, 2004 Settlement Facility Telephones Overwhelmed: The Claims Administrator for the Settlement Facility informs us that they are currently experiencing a very heavy volume of telephone calls to the Claims Assistance Program which may make it difficult for callers to get through with their questions. The Settlement Facility has extended calling hours and hired additional personnel to handle the volume, but the bottom line is patience is requested of everyone. The Settlement Facility has received tens of thousands of phone calls over the past week, and everyone at the Settlement Facility is working very hard to respond to each individual claimant's questions. A new interactive system for claimants to check on the status of their claim will be available by January 2005, and this should significantly ease congestion of the telephone systems.

The Claims Administrator has provided us with the following suggestions for claimants:
1. The best time to call (lowest call volume) is Thursday and Friday.
2. You can send questions by e-mail to the Claims Assistance Program at: info@sfdct.com (We are informed that they are current on responding to inquiries sent by e-mail.)
3. Check the Settlement Facility website (www.dcsettlement.com) for information and answers to your questions. The SF website contains a number of new "Questions and Answers" as well as the final Plan Documents (the Final Plan Documents can also be viewed on the CAC website by clicking on the link provided above).
4. When you access the answering system, please do not dial "0" to reach the operator. This will direct you outside of the Claims Assistance Program and you will have to re-dial to be reconnected.


Notice of Intent Form: If you would like a copy of the Notice of Intent form e-mailed to you, go to www.tortcomm.org and e-mail them and ask them to send you one. Time is limited, so do it immediately. Please indicate your name, address and telephone number in the body of your e-mail for our records. If you have a claim in the Dow Bankruptcy and have not filed, you need this intent to file form. You must submit this claim form by Aug. 29th.

Dow Corning has agreed to review implants (at no cost to the claimant) to determine if Dow Corning made the implant, and to let them know that Dow Corning has a pretty large inventory of implants that women or their doctors sent to Dow Corning over the years. This may be their only way to prove who made their implant, so women need to call Claims Assistance to see if Dow Corning has their implant. Source: TCC Member

SEPTEMBER 23, 2003: For women who have or had a Dow Corning breast implant, there are two new ways to meet "acceptable" proof of manufacturer. First, Dow Corning has acknowledged that there may be references in medical records to "Rubin" implants or labels that state, "Silastic Mammary Implant Rubin Design High Profile Contour, Q7-2573." This implant was commercially available during 1984 through 1986. It is Dow Corning's historical understanding that Dr. Rubin worked solely with DCC. Credible, contemporaneous documents identifying the claimant^(1)s breast implants as ^(3)Rubin^(2) implants, ^(3)Rubin Design^(2) implants or ^(3)Q7-2573 implants would be deemed Acceptable proof of manufacturer for implants implanted between 1984 and 1986. Any claim outside these years containing the terms ^(3)Rubin^(2), ^(3)Rubin Design^(2) or ^(3)Q7-2573^(2) should employ the waiver/IRP process.

Second, Dow Corning has acknowledged that approximately 50 breast implant claimants were implanted by Dr. Ben Gregory of Florida as part of a Dow Corning-sponsored clinical study. Dow Corning has supplied the names of the study participants to the Settlement Facility and acknowledged that these 50 persons will have acceptable proof of manufacturer of a Dow Corning breast implant. If you were implanted by Dr. Ben Gregory or believe that you were a participant in the Ben Gregory clinical study, call the Claims Assistance Program toll free within the U.S. and Canada at 1-866-874-6099 for more information.

Further, if you participated in the Dow Corning Removal Assistance Program (RAP) or the Product Replacement Expense Program (PREP), then Dow Corning has provided your name and implant information to the Settlement Facility. The existing product identification protocols provide that you have acceptable proof of manufacturer of a Dow Corning breast implant. Call the Claims Assistance toll free within the U.S. and Canada at 866-874-6099 for more information.

If you or your physician sent your implants to Dow Corning at any time, then Dow Corning may still have the implant in its possession. Dow Corning has provided a list of names of persons who sent them implants. You can call Claims Assistance to determine if your implants are at Dow Corning. If they are, then you may request that Dow Corning either return the implants to you or conduct a review to determine if Dow Corning made the implants. Contact the Claims Assistance Program for more information.

Patrick Hughes' answer to a question on explantation: The explant program will be separate and available to those wanting an explant who have in place DCC implants (not those from another manufacturer). The payment is made directly to a doctor.. The $5000 will also be paid to those who have been explanted since 12/31/90 and before 10 years after the Effective Date. Claimants cannot receive replacement silicone gel breast implants or they will void their right to the Explant Payment. I believe all payments for this or rupture come from the settlement fund, without regard to any subfunds. Based on the plan and settlement participation projections, there was adequate funding to pay these.

There is an "Explant Assistance Program" for women who do not have the funds available to pay for the cost of the removal surgery.

If an Explant claim has any deficiency, there is only 6 months from the date of the Notification of Status letter to submit additional proof to cure the deficiency. If a claimant does not cure within her 6 month deadline, she cannot recover any money for Explant. The deadline to submit an Explant claim is 10 years from the Effective Date.

Administrator's Corner: Last Updated: 06/14/2004: Dear Claimants and Counsel: As you are probably aware, we are experiencing an extremely high call volume and we may not be able to take your call in a timely manner. We ask for your continued patience as we work to give each claimant the personal attention that his or her call deserves. Please keep the following information in mind.

For those of you who are in Class 7 (Silicone Materials' Claimants), under Annex A, Section 6.04(h)(iii) no distributions of Disease Claims will be made from the Silicone Materials Claimants' Fund until each timely Silicone Material Claim is reviewed and evaluated under the Settlement Option selected and the one-year deadline to cure deficiencies, if any, has expired. Therefore you will not receive a payment for your claim in this calendar year.

For those of you who have a claim in Class 9, 10.1 or 10.2 (Other Products), under Annex A, Section 6.03(i)(ii) the Settlement Facility must review and evaluate all timely Other Products claims before distributing Medical Condition Payments to Other Product Claimants. Therefore, claimants will not receive a payment from the Other Products Fund in this calendar year.

Also, claimants are reviewed for settlement benefits in the order that their claims were received. To be reviewed for settlement benefits, you must have submitted a valid Waiver of Opt-Out form or a valid Participation Form in which you selected the Settlement Option. You must also submit acceptable proof of at least one Dow Corning implant (depending on the benefit option for which you are applying).

Once you have met these requirements, your claim for settlement benefits will be reviewed in the order in which it was received. If you are just now submitting your claim forms, you will be in line behind all of the other claimants who have submitted claim forms over the past year. Hopefully this information will prove helpful in answering your questions concerning the status of your claim.
Website: http://www.tortcomm.org/
Welcome to the new Claimants' Advisory Committee (CAC) website! We have redesigned the former Tort Claimants' Committee website to provide you with current information concerning the settlement and litigation options in the Settlement Facility-Dow Corning Trust (SF-DCT). We welcome all comments and questions so that we can make this website informative and useful as the Settlement Facility begins the process of issuing award letters and payments.


6/16/04 UPDATE: FIRST BATCH OF PAYMENTS MAILED: The first batch of payments to approved claimants was mailed June 15th. Additional payments will be mailed in early July 2004 and following at least monthly thereafter until all claims have been reviewed. Only claimants who received an award letter on or about June 1, 2004 will receive a payment in the June 15th mailing. Additional award letters and checks will be mailed, so please be patient.

If you have received a letter identifying a deficiency in your claim, then payment cannot be made until the deficiency is corrected. Please remember that there are very short time deadlines to cure a deficiency, so please take action immediately to submit additional documentation to cure the problem.

If you have not yet submitted claim forms or submitted them only recently, then you will probably not receive a status letter on your claim prior to the opt-out deadline of November 29, 2004. This is because claims are reviewed in the order that they are submitted, and there are tens of thousands of claims that are currently in line for processing. Claimants who know now that they want to remain in the Settlement Option must submit a Participation Form with the Settlement Option (Box 2A) checked for their claims to be reviewed and a status letter issued.

Payments will be issued separately for explant, rupture, and disease or expedited release. Therefore, if you submitted a claim for both explant and rupture and received only one award letter or one payment for explant for example, please be patient. You will receive a separate letter on the status of your rupture claim and on any other claim that you submitted.

URGENT INFORMATION FOR NOT-COVERED OTHER PRODUCTS CLAIMANTS: Dow Corning has provided the Settlement Facility and CAC with a list of products that it manufactured that are NOT eligible for compensation in the Class 9 /10.1 /10.2 Settlement Option (Class 9/ 10.1 and 10.2 are for claimants with a Dow Corning "Other Product" such as a hip, knee, chin, etc. implant). If you are in Class 9, 10.1 or 10.2, please review the list of not-Covered Other Products and the list of Covered Other Products (click on the link on this page called "Class 9, 10/1 and 10.2). As noted, claimants with these implants are not eligible for compensation from the Settlement Option; your only option is specified in the Litigation Facility Agreement at Section 5.2(a)(1) which states that:

"Claimants holding Children Direct Claims, Miscellaneous Raw Material Claims, and Other Products Claims which are not covered Other Products Claims have no settlement offer but have only the litigation option."

Also, the Amended Joint Disclosure Statement provides at Section 6.4(H) that: "Non-Settling Personal Injury Claimants, parties asserting Assumed Third Party Claims, Miscellaneous Raw Material Claimants and Other Products Claimants whose Claims do not arise from use of a Covered Other Product will have their Claims resolved through the procedures established by the Litigation Facility Agreement and the Case Management Order."

Claimants with a Dow Corning Other Product that is not a "Covered" Other Product (in other words, claimants whose only eligible implant or product is one listed on the chart included on this website under the heading "Class 9, 10.1 and 10.2) must file a lawsuit against the Litigation Facility, Inc. if they wish to pursue compensation. For example, silicone injection claimants are not offered any settlement benefits and are considered as not-Covered

Other Product Claimants. Currently, there is a dispute between Dow Corning and the CAC over whether a not-Covered Other Product claimant needs to complete the Participation Form and elect Box 2B (litigation) and return it to the Settlement Facility on or before November 29, 2004, or whether these claims are automatically considered opt-outs and are channeled to the Litigation Facility. To ensure your rights are protected, the CAC urges all claimants with a not-Covered Other Product who wish to pursue compensation to first contact an attorney for legal representation, to affirmatively opt-out by November 29, 2004, and to read the Case Management Order for information about deadlines and procedures to file a lawsuit against the Litigation Facility.

DOW CORNING SPONSORED CLINICAL STUDY PARTICIPANTS If you participated in a Dow Corning sponsored clinical study and received a Dow Corning implant but are having difficulty documenting this and the Settlement Facility rejected your Proof of Manufacturer documents about participating in a Dow Corning clinical study, please contact the CAC by clicking on the "Contact Us" link. We are investigating this issue now to determine if it can be added to the protocols for acceptable proof. Please provide specific information about the name of the doctor, hospital, the clinical study date, and any documents you received about participating in the clinical study (such as a consent form or follow-up information) including any correspondence from Dow Corning or Dow Corning Wright.

DOW CORNING TO REVIEW IMPLANTS FOR PROOF OF MANUFACTURER: The CAC has worked with Dow Corning and the Settlement Facility to establish a pilot program for claimants to submit their removed implants to Dow Corning for possible acceptance of Proof of Manufacturer. To be eligible to participate, you must agree to settle your claim in the Settlement Option (or have submitted a Conditional Waiver of Opt-Out Right Form), provide documents showing that your implants were in fact removed, and you must have your implants sterilized (to comply with applicable U.S. Postal and Department of Transportation regulations). For more information about this pilot program, contact the Claims Assistance Program at: info@sfdct.com.

MEDICAL INFORMATION: Aug., 2003: Study Suggests Link Between Ruptured Breast Implants and Fibromyalgia, by Elisabeth Deffner: An FDA study on the health affects of ruptured silicone gel breast implants has found that women whose implants have leaked outside the scar surrounding the implant were nearly three times more likely to have fibromyalgia.

The study comprised several parts. Participants responded to an FDA questionnaire asking whether they had persistent symptoms like swelling, stiffness, joint pain, or fatigue, and they were asked if they had been diagnosed with one of several specific illnesses, including fibromyalgia and chronic fatigue syndrome.

After participants were tested for implant ruptures and silicone gel leaks outside the fibrous scar surrounding the implant, it was discovered that those women with ruptures were no more likely than women with unruptured implants to report persistent symptoms for a doctor-diagnosed illness from those listed.

However, women with extracapsular leakage (silicone that migrated beyond the scar surrounding the implant) were 2.7 times more likely to report they had "other connective tissue disease," a category that included illnesses like fibromyalgia, chronic fatigue syndrome, lupus, and rheumatoid arthritis.

Researchers note that the association between silicone breast implants and fibromyalgia needs further study, particularly since this study did not distinguish between women who developed fibromyalgia before they underwent breast augmentation, and those who developed it afterwards.
In another study, the National Cancer Institute found that women with breast implants are not at increased risk for breast cancer. Women with breast implants are, however, two to three times more likely to have respiratory or brain cancer than people who underwent other types of plastic surgery.

Studies on breast implants often have seemingly contradictory results. Some have demonstrated that implants are benign, while others seem to indicate that they may be detrimental to the health.

The Food and Drug Administration has followed the results of various studies on implants. It pulled silicone implants off the market in 1992 as a result of health concerns, specifically that the implants might be connected to fibromyalgia and other types of chronic illness. (The 344 women participating in the FDA study each underwent breast augmentation surgery prior to 1988.)

Since 1999, when the Institute of Medicine (IOM) concluded that gel implants are not linked to connective tissue disorders, neurological problems, and autoimmune disorders, FDA opinion has swung in the other direction. Despite more recent findings that indicate silicone implants may indeed be detrimental to the health, they could be back on the market within as little as two years.

Researchers point out that more research is necessary to determine definitively whether or not silicone implants are harmful to the health of those women who augment their breasts with them. "If other studies are consistent with these findings, women should be informed of the potential of developing fibromyalgia if their breast implants rupture and silicone gel escapes outside the fibrous scar capsule," said Dr. S. Lori Brown, one of the authors of the study.

You can read more about these studies online. For information about silicone implants and fibromyalgia, go to: http://www.fda.gov/cdrh/breastimplants/extracapstudy.html

How To Win Your Fibromyalgia Social Security Disability Case the First Time Or On Appeal
L
As a former Social Security disability examiner, I was always frustrated and saddened when a Fibromyalgia case came across by desk that lacked the important and critical information that would, if complete, help move those cases much faster through the system. In many cases the information would get the person allowed. Without it, the processing time was generally extended from 90 to 180 days or longer and the likelihood of denial was much greater.

As a private pilot I have always made a point of using a checklist before I ventured out into unknown skies. I think the word or words are proactive and in control. These same principles are critical when filing for Social Security disability benefits.

The reason most if not all Fibromyalgia cases are denied by Social Security disability determination examiners, Social Security doctors and Hearing and Appeals judges is the lack of solid personal, medical/psychiatric and vocational evidence that will support an unquestionable allowance.

How To Make It Happen The Puzzle

Most people that have been denied Social Security disability benefits in Fibromyalgia cases is because they have the false and dangerous assumption that their medical evidence alone will be strong enough to stand on its own merit to get them allowed. Unfortunately this thinking continues to put a lot of deserving people in harms way.

Most all of the successful Social Security disability Fibromyalgia cases are allowed on strong personal, medical/psychiatric and vocational evidence. The personal, psychiatric and vocational evidence is the leverage that's critical to getting you across the finish line a winner. Why?

Typical with Fibromyalgia cases is the major depression caused by the severe and continuous pain and lack of sleep. The depression can and does some serious mental limitations with respect to completing normal daily activities like cleaning, shopping and cooking. More serious is the degree that social functioning is also severely affected with respect to your inability to get along and interact with others, as well as the social isolation resulting in the inability to keep a job because of the severe pain and depression.

The final and most significant blow with respect to your inability to work and being allowed Social Security disability benefits is how your concentration; persistence and pace are severely affected as a result of your severe pain and depression. All are important in reference to your inability to sustain focused attention and concentration sufficiently long enough to permit the timely and appropriate completion of tasks commonly found in work settings. Having current personal and psychiatric evidence will go a long way to verify the fact that you are unable to do your past work or any other work without exception.

In closing I can only hope that some of the information I have shared with you will make your journey to get the disability benefits you deserve less taxing. Sincerely, Michael Davidson President, The Summit Organization, Inc.

November 2003: Health Complications from Breast Implant Surgery: A Canadian Study with Implications for the U.S. By Aleina Tweed, British Columbia Centre of Excellence for Women's Health: For decades, women who have undergone breast implant surgery have reported high implant failure rates and unidentifiable illnesses. In 1992, silicone gel-filled implants were subject to government moratoriums in the United States and in Canada, until such time as their safety could be assured. In the years that have followed, researchers have tried to find answers. In the meantime, breast implantation continues to become more and more popular, with saline-filled implants taking the place of their silicone predecessors.

In Canada and the United States, approximately 20% of implant surgeries are for reconstruction, primarily after cancer or prophylactic mastectomy, and 80% are cosmetic augmentation. Such surgery is not considered medically necessary and is therefore paid for privately. However, when there are health consequences of this surgery whether local complications or controversial systemic complications Canadian women enter the public health care system for their care.

High complication rates have been well-documented. A Mayo Clinic study in the United States, for example, found that 25% of women with breast implants suffered local complications requiring additional surgery within five years. Studies by implant manufacturers in the U.S. have reported that most reconstruction patients and a large proportion of augmentation patients report at least one serious complication within three years. In addition, there were 103,343 adverse reaction reports regarding silicone breast implants and 23,454 reports for saline implants received by the U.S. Food and Drug Administration between 1985 and 1996.

A new study by researchers at the Centre of Excellence for Women's Health in British Columbia finds relatively high complication rates for breast implantation in Canada as well. Data collected from a study group of 147 women who had undergone breast implant surgery were compared to data from a non-implant comparison group (583 women). The study reported that women who have or have had breast implants:

? visited doctors and specialists significantly more often

? were more than four times as likely to be hospitalized, and

? experienced more hospitalizations over the study period than women without implants.

All these differences were significant when age, marital status, education level, exercise, use of alcohol, and geographic region were statistically controlled. Types of implants (saline or silicone gel) did not significantly affect hospitalization or medical utilization. The study also found that over half (51%) of respondents from the study group reported at least one additional breast-implant related surgery subsequent to the initial implantation. Of those, half (49%) had undergone one additional surgery, 23% had undergone two, 11% had undergone three, and 17% had undergone four or more additional surgeries. For some of these women, the complications were enough to convince them that they no longer wanted breast implants. Forty percent of respondents had had their implants permanently removed.

One-third of the women in the study had implants for less than 10 years (some for just a few months) and 42% had implants for 11-20 years. Compared to most other studies, these women had implants for a longer period of time. Although more than two out of three (71%) reported their health as good or excellent, half had been diagnosed with at least one chronic illness, one in three had quit their job or reduced their work hours because of health problems, and more than half had problems doing housework or recreational activities because of health problems.

Breast implant surgery is not deemed medically necessary and is performed and paid for privately in the vast majority of cases. However, it appears to directly contribute to an increased need for public health care services among the women receiving these devices. If, as the literature suggests, serious local complication rates are at least 25% and more likely are 50% or higher there are many thousands of women in Canada and the U.S. who are using greater health care resources as a result of this surgery, and whose health and well-being may be at risk.

Complications with Breast Implantation
There are three major groups of health complications associated with breast implants: local complications, systemic complications and psychological complications. Breast implant surgery also carries the same risks associated with any surgical implantation of a medical device. All aesthetic complications (dissatisfaction with size, position, etc., of the implants) are not funded by public health care; however, in Canada all health complications resulting from the implant, including the removal of the implants, are covered by publicly funded health care. In the U.S., most of the medical care caused by these complications must be paid for by the woman herself.

1. Surgical complications: Any surgery and breast implantation is no different involves risks such as complications of general anesthesia, infection, haematoma, hemorrhage, thrombosis, skin necrosis, delayed wound healing and additional surgeries.

Most women with breast implants will require additional surgery or surgeries related to their implants. These procedures may include treatment of capsular contracture, correction of the implant's size or position, infection control as the result of other local or systemic complications, or to prevent or treat leakage, rupture or other health problems.

2. Local complications: Local complications can range from very mild to very severe, and they affect a large percentage of women who undergo breast implant surgery. Capsular contracture is one of the most common; contraction of the wall of scar tissue surrounding the breast implant may cause hardness of the breast, discomfort and even severe pain. According to Health Canada, capsular contracture occurs, usually within two years of surgery, in approximately 25% of women who undergo breast implant surgery. Other researchers suggest the percentage is as high as 70%.

Implant deflation and rupture caused by normal deterioration over time, breast trauma, undetected damage or shell weakness in the implant are significant complications; one study found that 70% of removed implants 11 to 15 years old were ruptured or leaking. In a study by the U.S. FDA, two-thirds of 344 implanted women examined with MRI had ruptured implants. Deflation, leakage and rupture can result in the breast implant filling being spread through the body. When the filling is silicone gel, the silicone can migrate to other parts of the body and be difficult or impossible to remove.

Other complications include change in shape or volume of the breast; change in breast sensation; calcium deposits; mammographic interference, and breast/chest discomfort or pain and nipple discharge.

3. Systemic complications: Systemic complications appear most frequently several years after breast implantation. These complications tend to present as a cluster of symptoms, including those associated with autoimmune diseases, connective tissue diseases, "human adjuvant disease" and/or fibrositis/fibromyalgia-like disorders. (The classic autoimmune and connective tissue diseases thought to be associated with silicone implants are scleroderma, lupus, mixed connective tissue disease, rheumatoid arthritis and Sjogren-Larsson syndrome.) Women with breast implants have also reported granulomas and lymph node involvement, chronic flu, respiratory problems and infections. Cancer also remains a concern; a study by the National Cancer Institute found women with breast implants were more likely to die from brain cancer or lung cancer compared to other plastic surgery patients.

The link between breast implants and systemic complications is still not clearly understood. Epidemiologic research has not been conducted on large numbers of women who had implants for at least ten years, which would be a reasonable period of time to determine the health risks.

4. Psychological consequences: Unfortunately, studies of the psychological consequences of breast augmentation have been largely anecdotal, consisting primarily of surgeons' reports of their patients' satisfaction. These reports suggest that typically 70% or more of patients report satisfaction with their surgical outcome. However, such investigations clearly have serious problems. How many patients will admit, face-to-face with their surgeon, that they are not satisfied with the results of their surgery? How many surgeons will admit that their patients are not satisfied?

Many studies suggest that cosmetic surgery in general leads to immediate post-operative improvements in body image, quality of life and depressive symptoms. However, the FDA pointed out at their October 14 public meeting that the Inamed studies found a decline in most mental health and quality of life measures two years after getting breast implants, compared to before implantation. Those findings were consistent for augmentation or reconstruction patients.

Other studies have found that women who have their breast implants removed without replacement report higher levels of breast anxiety, upper torso dissatisfaction and depression both before and after implant removal, compared to women who have undergone other cosmetic surgery and women who have not undergone any cosmetic surgery. Since many women have their breast implants removed, these findings suggest that breast implant surgery leads to poorer psychological well-being, rather than better, for many women

NEW YORK (Reuters Health) - The use of antibiotics appears to be associated with an increased risk of breast cancer and fatal breast cancer, according to the results of a new study reported in this week's issue of the Journal of the American Medical Association (news - web sites).

However, the investigators add that although a relationship has been found, their findings do not prove that antibiotic use is the cause of
breast cancer in these women and they note that other factors may be involved. Earlier reports have suggested a link between antibiotics and increased cancer risk, lead author Dr. Christine M. Velicer of the University of Washington, Seattle and colleagues note. The effects of these drugs on the microorganisms normally found in the intestines and the way estrogen is processed, as well as their effects on the immune system and on inflammation, have been suggested as
possible ways antibiotics may influence the development of cancer.

To further investigate a possible relationship, Velicer's group evaluated data collected for 2266 women with primary, invasive breast cancer between 1993 and 2001, and 7953 randomly selected women without breast cancer who were enrolled in the same health plan. "We found that increasing cumulative days of antibiotic use and increasing cumulative number of antibiotic prescriptions were associated with increased risk of incident breast cancer, after controlling for age and length of enrollment," they report.

When compared with women with no history of antibiotic use, women with cumulative antibiotic use for 1 to 500 days had a 2.5-fold increase risk of breast cancer. "Increasing cumulative days of antibiotic use was also associated with death due to breast cancer, controlling for age, length of enrollment, and ever use of postmenopausal hormones," they write.

The investigators stress, however, that "it cannot be determined from this study whether antibiotic use is causally related to breast cancer, or whether indication for use, overall weakened immune function, or other factors are pertinent underlying exposures." "This observation is potentially worrisome in that antibiotic exposure is common and sometimes nonessential," Drs. Roberta B. Ness and Jane
A. Cauley of the University of Pittsburgh comment in an accompanying editorial. "Thus, if real, the risk of breast cancer attributable to
the use of antibiotics could be large and partially preventable."

The study provides more questions than answers, they add. Both the authors and editorialists agree that the clinical implications of the study are unclear and than more studies are needed to explore the relationship between antibiotic use and cancer risk. SOURCE: Journal of the American Medical Association, February 18,2004.


3/03/04 DURHAM, N.C. -- Stress is a well known culprit in disease, but now researchers have shown that stress can intensify the effects of relatively safe chemicals, making them very harmful to the brain and liver in animals and likely in humans, as well. Even short-term exposure to specific chemicals -- just 28 days -- when combined with stress was enough to cause widespread cellular damage in the brain and liver of rats, said Mohamed Abou Donia, Ph.D., a Duke pharmacologist and senior author of the study. Results of the study were published in the Feb. 27, 2004, issue of the Journal of Toxicology and Environmental Health.

Abou Donia's study was designed to reproduce the symptoms of Gulf War Syndrome, a disorder marked by chronic fatigue, muscle and joint pain, tremors, headaches, difficulties concentrating and learning, loss of memory, irritability and reproductive problems. The Gulf War Syndrome symptoms have been difficult to explain because veterans outwardly appear healthy and normal, said Abou Donia. Likewise, the chemically exposed animals in Abou Donia's studies looked and behaved normally. But a decade of neurologic research has revealed widespread damage to the brain, nervous system, liver and testes of rats exposed to 60 days of low-dose chemicals -- the insect repellant DEET, the insecticide permethrin, and the anti-nerve gas agent pyridostigmine bromide. These are the same drugs that the soldiers received during the 1990 - 1991 Persian Gulf War, and Abou Donia's rats were exposed to the same levels -- in weight adjusted doses -- as the soldiers were reportedly given.

Now, Abou Donia has demonstrated that the combination of stress and short-term exposure to chemicals (28 days) can promote cellular death in specific brain regions and injury to the liver. Moreover, the chemical trio combined with stress caused damage to portions of the brain where its protective blood-brain barrier was still intact.

The latter finding suggests that the chemicals permeated the protective barrier in one region, then leaked into other regions of the brain where the barrier remained intact. The ability of chemicals to leak from one area of the brain to another holds the potential for much greater damage to occur to the entire brain. Brain regions that sustained significant damage in this study were the cerebral cortex (motor and sensory function), the hippocampus (learning and memory) and the cerebellum (gait and coordination of movements). Abou Donia's earlier studies demonstrated severe damage to the cingulate cortex, dentate gyrus, thalamus and hypothalamus. (The thalamus is the major relay for visual and auditory information going to the cortex and is also responsible for subjective feelings. The hypothalamus regulates metabolism, sleep and sexual activity, as well as control of emotions.)
Abou Donia's team found a significant number of dead or dying brain cells in all of these brain regions, as well as major alterations to brain chemicals that are necessary for learning and memory, muscle strength and body movement. Stress alone caused little or no brain injury in the rats, nor did the three chemicals given together in low doses for 28 days. "But when we put the animals under moderate stress by simply restricting their movement in a plastic holder for five minutes at a time every day, the animals experienced enough stress that it intensified the effects of the chemicals dramatically," said Abou Donia.
Soldiers in the Gulf War were likely under stress 24 hours a day for weeks or months at a time, a scenario which could explain the origins of their diverse physical and cognitive complaints, said Abou Donia.

"The brain deficits we found in rats reside in specific areas of the brain that we can't measure in living humans," said Abou Donia. "This is why the deficits are so difficult to assess clinically and why animal studies are so critical to understanding the cellular damage."

In addition to brain injuries, the Duke study found unexpected damage to the liver, including swollen cells, congested blood vessels and abnormal fatty deposits that diminish the liver cells' function. Liver cells also showed reduced activity of an important enzyme -- BuCHE -- that helps rid the body of some toxic substances. Neither stress by itself nor chemicals alone had any impact on BuCHE levels, but the combination did.

Such damage to the liver can reduce its ability to rid the body of toxic substances -- its primary function as a vital organ. And, the less effectively the liver filters out toxic substances, the more the chemicals can concentrate in the brain and nervous system, he added.

Finally, the study showed that stress plus chemicals increased the amount of destructive molecules in the brain called reactive oxygen species -- also known as oxygen free radicals. Reactive oxygen species are produced by the body as it metabolizes various substances in the presence of oxygen. Reactive oxygen species attack DNA, RNA and proteins, causing cellular and membrane damage. Normally, the
body removes these chemicals from the body and the brain. But excessive production of reactive oxygen species can overwhelm the body's ability to dispose of them.

"In our study, there was an increase in reactive oxygen species. We think that either the three chemicals and stress directly produce these free radicals, or the chemicals impede the body's ability to get rid of them," said Abou Donia. Source: Duke University.

An FDA study on problems with mammography for women with breast implants was published in the Journal of Women's Health in May, 2004. (1). The preliminary results of this study were presented at the FDA Science Forum in April, 2003. The study was a review of adverse event reports from the FDA's Manufacturer and User Facility Device Experience (MAUDE) database
(http://www.fda.gov/cdrh/databases.html).
Researchers found 66 reports that mentioned problems with mammography for women with breast implants.

The majority (62.1%) of problems reported were for breast implant rupture that was suspected to occur during mammography. Rupture during compression for mammography was reported for both silicone gel-filled and saline-filled breast implants. Other adverse events reported to FDA included implants crushed by mammographic compression, pain during mammography attributed to the implants, inability to perform mammography because of capsular contracture or because of fear of implant rupture, and delayed detection of cancer attributed to the breast implants. It is unknown how often these problems occur because the MAUDE database cannot be used to determine rates of problems occurring.

FDA researchers also reviewed published medical literature on mammography for women with breast implants. Their review found medical reports describing:
* an additional 17 reported cases of breast implant rupture during mammographic compression
* breast implant interference with imaging breast tissue, with between 22% and 83% of mammographically visualizable breast tissue obscured by breast implants
* special techniques needed to maximize breast tissue visualization for women with breast implants
* a delay in breast cancer detection in women with implants, but without increased mortality to women with implants.

The risk for breast cancer does not differ in women with breast implants compared to other women. Recommendations for breast cancer screening also apply to women with breast implants. Women considering breast implants should be aware of potential issues with mammography in order to make an informed decision. Women who already have breast implants should always inform the mammography center that they have breast implants when they make an appointment and always remind the mammography technician that they have breast implants when they go for their exam.

(1) Brown SL, Ferlo Todd J. Luu H-MD. Breast implant adverse events during mammography: reports to the Food and Drug Administration. Journal of Women's Health. Volume 13, Number 4, 2004.

AB Birkefeld, H Eckert, and B Pfleiderer: A study of the aging of silicone breast implants using (29)Si, (1)H relaxation and DSC measurements. Biomaterials, August 1, 2004; 25(18): 4405-13.Institute of Physical Chemistry, University of Mu"nster, Schlossplatz 4/7, D-48149 Mu"nster, Germany.

In this study 26 previously implanted silicone breast implants from the same manufacturer (Dow Corning) were investigated with two different analytical methods to characterize potential aging processes such as migration of monomer material from the gel and shell to local and distant sites, chemical alterations of the polymer, and infiltration of body compounds such as lipids.(1)H and (29)Si NMR relaxation measurements (spin-lattice, [Formula: see text], and spin-spin, [Formula: see text], relaxation times) were used to study the molecular dynamics of polysiloxane chains, both in gels and in shells. In addition, changes in physical properties were monitored by differential scanning calorimetry (DSC).

The results of these measurements indicate that NMR relaxation times are influenced by implant generation, implantation time, shell texture and implant status. (1)H [Formula: see text] values of shells and gels show a tendency to increase with increasing implantation time, indicating higher mobility and possible disintegration of the polymer network of older implants.

Furthermore, the data suggest that aging also involves the migration of low cyclic molecular weight (LMW) silicone and linear chain polymer material from the gels into the shells. The high "bleeding" rate of second-generation (G2) implants (implantation period around 1973-1985), exhibiting thin shells is reflected in reduced relaxation times of these devices, most likely due to a loss of low molecular weight fractions from the gels.

Moreover, "gel bleeding" also influences the melting behavior observed in DSC studies. Increased shell rigidity (high [Formula: see text] and [Formula: see text] ) tends to be correlated with longer (29)Si relaxation times of the corresponding gels, suggesting a reduced transfer of LMW silicones and linear chain polymer from the gel to the shell and to the outside. Remarkably, textured implants seem to be less susceptible to degradation processes than implants with thin shells.


Los Angeles Times, March 20, 2004:
Federal Caveat Issued on the Catch of the Day, By Richard Simon, Times Staff Writer

WASHINGTON The federal government on Friday warned that pregnant women and young children should limit their intake of tuna and other types of seafood because the mercury content can harm developing nervous systems.

But the advisory by the Food and Drug Administration and the Environmental Protection Agency also said tuna that staple of school lunches and diet menus offered health benefits that should not be ignored.

That triggered a political food fight, with consumer and environmental groups complaining the advisory did not go far enough, and a tuna industry official accusing critics of trying to scare people away from a food that was low in fat at a time when America faced an obesity epidemic.
A member of an FDA advisory group resigned in protest, saying the agency should have discouraged more strongly the consumption of albacore tuna by pregnant women.

Abstract: Anal. Bioanal Chem (2003) 375: 356-362--Daniela Flassbeck, Bettina fleiderer, Patrick Klements, Klaus G. Heumann, Elke Eltze, Alfred V. Hirner: Determination of siloxanes, silicon, and platinum in tissues of women with silicone-gel-filled implants: Published online: 28 January 2003.

Silicone (poly/dimenthylsiloxane)) gel used in breast implants has been known to migrate through intact silicone elastomer shells, resulting in the clinically observable "gel bleed" on the implant surface. Although silicon concentrations in capsular tissues of women with silicone protheses have been measured with element-specific silicone analyses, no silicone-specific investigation of these tissues has been performed as yet.

This investigation of human tissues by a combination of element-specific and species-specific analytical techniques clearly demonstrates for the first time that platinum
and siloxanes leak from prostheses and accumulate in their surrounding tissues.

Chronic Fatigue Syndrome: As many as 80% of CFS patients have a history of allergies, compared to 15% of the general population. When an allergic reaction occurs, the IgE antibody binds to the allergen (the foreign substance that induces the allergy), causing a release of histamine. Histamine is responsible for many of the symptoms related to allergy, such as fatigue, headaches, respiratory problems, and so on. Since such a high percentage of CFS patients have allergies, it may be possible that their immune systems are overreacting to the presence of general infectious agents in the same way they overreact to the presence of allergens. (Source: Chronic Fatigue Syndrome: A complete guide to symptoms, treatments, and solving the practical problems of CFS. By Gregg Charles Fisher, with contributions by Paul Cheney, M.D., Ph.D., Nelson Gantz, M.D., David Klonoff, M.D., and James Oleske, M.D.)

Inflammation: A new link to disease: Inflammatory substances in body may help cancer spread. April 18 One of the current "hot topics" in health research is how inflammation affects our risk of heart disease, stroke, diabetes and even cancer. Scientists are increasingly focused on a certain kind of inflammation specifically, the form that takes place deep in our cells and tissues and the important role it may play in the development of disease.

Normally, inflammation is a good sign. When your thumb swells up after you accidentally bang it with a hammer, it tells you that your immune system is sending white blood cells and other, hormone-like substances to help start the healing process. But not every kind of inflammation is that easy to see, and it's the invisible kind that takes place throughout our body, over and over again, that is attracting so much attention.

COX-2 is an enzyme in our bodies that boosts the production of inflammatory chemicals. Normally, these proteins and hormone-like substances are churned out by our immune systems with no ill effects.

Under certain conditions, however, they may actually help cancer cells multiply and spread. That's why one type of anti-inflammatory drugs, collectively called COX-2 inhibitors, are under study for a potential role in preventing or treating cancers of the colon, uterus, breast, prostate and other tissues.

Does nutrition play a role? And now, scientists are investigating whether the way we eat could also influence the kind of chronic inflammation that might be linked to cancer risk and other health problems.

Other scientists are seeking to determine if inflammation may be one reason that obesity has been linked to higher cancer risk. Research now suggests that the body's fat cells produce cytokines (proteins that promote low-grade inflammation) and that the distribution of body fat might also play a role.

A study in the Journal of the American Medical Association shows that one measure of inflammation increased by more than 50 percent in obese women whose fat was mainly in their hips and thighs ("pear-shaped"), and by more than 400 percent in obese women with significant waistline fat ("apple-shaped").

Interestingly, some studies now show that regular exercise may have precisely the opposite effect on the immune system, and may reduce levels of inflammatory proteins. This might help to explain why research has linked regular physical activity with lower cancer risk

Research on plant-based diets: Still other scientists, including many sponsored by the American Institute for Cancer Research, are investigating how an overall plant-based diet might help keep inflammation in check. Antioxidant nutrients and phytochemicals in fruits and vegetables protect cells' DNA from damage that can lead to cancer; and some evidence now suggests they may also lower production of inflammation-promoting hormones. In fact, a wide variety of natural phytochemicals found in fruits and vegetables are under investigation for possible COX-2 lowering effects.

All of this evidence linking diet to the kind of chronic inflammation associated with cancer risk is still preliminary, however, and it would be premature to change our diets if this was the only reason to do so. Of course, it isn't the only reason a plant-based diet with plenty of fruits and vegetables, maintenance of a healthy weight and regular exercise is already a strategy that is estimated to lower cancer risk by 30 to 40 percent. We know that it works the incoming research about inflammation may soon help us get a better idea of some of the how and why.

Nutrition Notes is provided by the American Institute for Cancer Research in Washington, D.C. From PubMed

Rupture of Silicone Gel Breast Implants and Symptoms of Pain and Fatigue: RUUD C.W. VERMEULEN and HANS R. SCHOLTE.

ABSTRACT. Objective: To compare symptoms of women with silicone gel breast implants and women with chronic fatigue syndrome (CFS), and to study the effect of rupture of the silicone implant.

Methods: Five hundred readers of the Dutch silicone breast implant support group magazine were asked to respond if they had been informed by the surgeon about the silicone implant status at removal operation, and to answer questions about symptoms of CFS. Their complaints were compared with those of 100 female patients with CFS and 40 female controls.

Results: The questionnaires were returned by 319 women. Of these, 227 had symptoms of debilitating chronic fatigue. The patterns of symptoms differed from those in patients with CFS. An analysis of the relation between integrity of the implants and the symptoms could be carried out in 176 women, and 74% of these latter women reported ruptured implants. Significantly more women with ruptured implants than those with intact implants had debilitating chronic fatigue (75% vs 51%), postexertional malaise > 24 h (77% vs 51%), impaired short term memory (58% vs 38%), and multi-joint pain (77% vs 60%).

Conclusion: Women with silicone breast implants often report severe pain and chronic fatigue. Rupture of the implant is associated with an increase in symptoms of pain and chronic fatigue. (J Rheumatol 2003;30:22637)

What is Restless Legs Syndrome?
Restless legs syndrome is a sensori-motor (movement) disorder characterized by uncomfortable sensations in the legs, which are worse during periods of inactivity or rest or while sitting or lying down. There is often a positive family history of the disorder. Individuals affected with the disorder describe the sensations as pulling, drawing, crawling, wormy, boring, tingling, pins and needles, prickly, and sometimes painful sensations that are usually accompanied by an overwhelming urge to move the legs. Sudden muscle jerks may also occur. Movement provides temporary relief from the discomfort. In rare cases, the arms may also be affected. Symptoms may interfere with sleep onset (sleep onset insomnia). Research suggests that restless legs syndrome is related to periodic limb movement disorder (PLMD), another more common motor disorder which causes interrupted sleep. The symptoms often exhibit circadian rhythmicity in their peak occurrence during awakening hours.

Is there any treatment? Treatment for restless legs syndrome is symptomatic. Massage and application of cold compresses may provide temporary relief. Medications such as temazepam, levodopa/carbidopa, bromocriptine, pergolide mesylate, oxycodone, propoxyphene, and codeine are effective in relieving the symptoms. However, many of these medications have side effects. Current research suggests correction of iron deficiency may improve symptoms for some patients.

What is the prognosis? Restless legs syndrome is a life-long condition for which there is no cure. Symptoms may gradually worsen with age, and their most disabling feature is the sleep onset insomnia they cause, which can be severe.

What research is being done? The NINDS supports an extensive program of basic and clinical research aimed at discovering the mechanisms responsible for many motor disorders such as restless legs syndrome, especially those associated with sleep changes. The goal of this research is to discover ways to prevent, diagnose, treat, and, ultimately, find cures for motor disorders including restless legs syndrome.


What is Restless Legs Syndrome?
Restless legs syndrome is a sensori-motor (movement) disorder characterized by uncomfortable sensations in the legs, which are worse during periods of inactivity or rest or while sitting or lying down. There is often a positive family history of the disorder. Individuals affected with the disorder describe the sensations as pulling, drawing, crawling, wormy, boring, tingling, pins and needles, prickly, and sometimes painful sensations that are usually accompanied by an overwhelming urge to move the legs. Sudden muscle jerks may also occur. Movement provides temporary relief from the discomfort. In rare cases, the arms may also be affected. Symptoms may interfere with sleep onset (sleep onset insomnia). Research suggests that restless legs syndrome is related to periodic limb movement disorder (PLMD), another more common motor disorder which causes interrupted sleep. The symptoms often exhibit circadian rhythmicity in their peak occurrence during awakening hours.
Is there any treatment?
Treatment for restless legs syndrome is symptomatic. Massage and application of cold compresses may provide temporary relief. Medications such as temazepam, levodopa/carbidopa, bromocriptine, pergolide mesylate, oxycodone, propoxyphene, and codeine are effective in relieving the symptoms. However, many of these medications have side effects. Current research suggests correction of iron deficiency may improve symptoms for some patients.
What is the prognosis?
Restless legs syndrome is a life-long condition for which there is no cure. Symptoms may gradually worsen with age, and their most disabling feature is the sleep onset insomnia they cause, which can be severe.
What research is being done?
The NINDS supports an extensive program of basic and clinical research aimed at discovering the mechanisms responsible for many motor disorders such as restless legs syndrome, especially those associated with sleep changes. The goal of this research is to discover ways to prevent, diagnose, treat, and, ultimately, find cures for motor disorders including restless legs syndrome.
Select this link to view a list of all studies currently seeking patients.

Restless Legs Syndrome Foundation:
819 Second Street, SW Rochester, MN 5902-2985
rlsfoundation@rls.org http://www.rls.org
Tel: 507-287-6465 Fax: 507-287-6312

(I have this disorder, and have found that taking 400 mg. of magnesium glycinate at dinner and at bedtime helps tremendously. Lynda)

Pot-like chemical helps brain overcome fear, researchers say: (July 31, 2002 5:39 p.m. EDT) - Natural molecules that act like the primary active ingredient in marijuana apparently play a key part in helping the brain wipe away fearful memories, perhaps averting undue anxiety and panic attacks, researchers report.

The discovery, detailed in the British journal Nature, could lead to the development of psychiatric drugs for the treatment of such fear-based conditions as phobias and post-traumatic stress disorder, they said. The results of the mouse studies provide clues to the influence on human behavior of so-called "endocannabinoids," naturally occurring molecules related to the psychoactive ingredient in cannabinoids such as pot and hashish that have been used for medicinal and recreational purposes for some 3,000 years.

The ingredient, called delta9-tetrahydrocannabinol or delta9-THC, affects the nerve cells in the brain, producing its signature mind-altering effects by attaching itself to a protein on the surface of each cell. The protein, called the CB1 receptor, also provides a critical hook-up point for the endogenous cannabinoids - the cannabinoids naturally produced by the body. Without it, the chemicals cannot do their prescribed job.

The five-year study, by Beat Lutz of the Max Planck Institute of Psychiatry in Munich, Germany, and his German and Italian colleagues, revealed a previously unknown component of that job - snuffing out terrifying memories as part of the body's fear-coping mechanism.

"Our work shows an involvement of the endogenous cannabinoid system in extinction of fear memory for the first time," Lutz told United Press International.

"We really had no idea before that this system might be involved in erasing of particular types of memories," neuroscientist Pankaj Sah of Australian National University in Canberra, Australia, who wrote an accompanying commentary, told UPI.

"Although we understand how fearful memories are stored in the brain, how they are extinguished remains a mystery. The answers may lie with the cannabinoid compounds our bodies produce," he added. "The finding might have implications for treating anxiety disorders in humans."

Anxiety disorders are the most common of all mental health diseases, costing the United States some $46 billion a year in direct and indirect health-care expenses. Social phobia, the No. 1 anxiety disorder, affects some 5.3 million Americans annually. The persistent, irrational fear of social interactions leads to a compelling desire to avoid them at any cost. Specific phobias, of animals, objects or situations, touch more than one out of every 10 persons in the United States.

Another 5.2 million Americans suffer from post-traumatic stress disorder, characterized by emotional numbness and denial in the wake of extreme psychological stress brought on by war, violence, childhood abuse, sexual attack or serious accident, followed by months or years of recurring nightmares, "flashbacks," short-term memory problems, insomnia or heightened sensitivity to sudden noises.

Estimated cases of panic disorder - sudden, repeated, intense feelings of terror and impending doom - range between 3 million and 6 million a year. Twice as many women as men suffer the disorder that renders them sweaty, weak, faint, dizzy, trembling, numb and believing they are losing their mind or facing imminent death.

Such exaggerated reaction to a perceived threat - be it a social engagement or an animal encounter - is a legacy left humans by their earliest ancestors. This evolutionary inheritance includes instincts to stay alert in potentially dangerous situations, including binding or boundless spaces, lofty heights or impending confrontations with creatures perceived as repulsive or threatening, such as spiders or snakes.

Guarding against possible hazards is as important as recognizing false alarms. When the prospect of danger fails to materialize, most humans sigh with relief and relax. But there are those, termed phobics, who cannot adapt and remain on high alert even in the absence of any threat. Examples include the uncontrollable over-reaction that leads to panic attacks or the emotional scars from accidents, war experiences or other traumatic experiences that fail to heal with time. The new findings point to the endogenous cannabinoid system of the brain as a key prop in this delicate balancing act.
In the experiments, normal mice and those lacking the cannabinoid receptor CB1 heard a tone, then felt an electric shock to the foot. Over the next few days, the researchers sounded the tone without administering the shock. The normal rodents soon started to regard the sound as benign and stopped responding by freezing in fear. The mutants, on the other hand, continued for a much longer time to react to the tone as if it portended terrible things to come.

"All animals showed a remarkable fear reaction during the first re-exposure to the tone," Lutz explained. "With repeated tone presentations, control mice quickly recovered from this fear reaction. CB1-deficient mice, in contrast, showed only a weak reduction of fear."

To wipe away frightful recollections, endocannabinoids flood the amygdala - the brain's almond-shaped center of threat recognition, fear and aggression - where they dampen the action of its nerve cells, helping to dismantle terrifying associations. Drugs that boost the chemicals' activity in this region of the brain might help sufferers of post-traumatic stress disorder, phobias, panic attacks and certain forms of chronic pain, scientists told UPI.

"The finding that the endocannabinoids contribute to extinction raises the possibility that drugs that target these molecules and their receptors could be useful new treatments for anxiety disorders," Sah said.

Once thought of as character flaws, these conditions are now recognized as having biological and psychological components. Treatment often combines medication with psychotherapy. "To my mind (the study) raises issues about why people use cannabis in the first place," Sah told UPI. "We all take aspirin for headaches and toothaches - of course, aspirin does not have the same gamut of cognitive actions as cannabis. But it's worth considering that people (who) constantly use cannabis may be doing it for other reasons than just to 'get high' - perhaps they are experiencing some emotional problems which taking cannabis alleviates. Much the same way as some people drink alcohol to relieve anxiety."

Sah concluded, "This work tells us that the cannabinoid system is very old and plays roles in evolutionarily quite old behaviors. This, I suppose, fits with the very long history of use of cannabis in human society. It tells us that trying to work out how cannabinoids act is a very useful exercise whose outcome could have important medical benefits in the future."

Breast implant induced alopecia: Silicone breat implants may induce alopecia according to some publications. How this might occur is not known, but most likely an adverse immune reaction occurs against the silicone. The immune system reaction may directly promote alopecia through skin inflammation and disruption of the hair follicles or it may indirectly cause hair loss through a reduction in general health as occurs in chronic inflammatory diseases. The immune system response can lead to much more than just hair loss with various inflammatory conditions being reported in women with implants. Conditions arising from a reaction to breast implants include the autoimmune disease Sjogren's syndrome, and/or more subtle symptoms including fatigue, stiff and arthritic joints Raynaud's phenomenon (cold fingers and toes), adenopathy, night sweats, and frequent sore throats. Alopecia may be just one of many symptoms.
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Breast implant induced alopecia references
* <http://www.keratin.com/ae//ae/ae008ref001.shtml>Freundlich B, Altman C, Snadorfi N, Greenberg M, Tomaszewski J. A profile of symptomatic patients with silicone breast implants: a Sjogrens-like syndrome. Semin Arthritis Rheum. 1994 Aug;24(1 Suppl 1):44-53.
* <http://www.keratin.com/ae//ae/ae008ref002.shtml>Solomon G. A clinical and laboratory profile of symptomatic women with silicone breast implants. Semin Arthritis Rheum. 1994 Aug;24(1 Suppl 1):29-37.
* Huang CL, Kuo TT, Chan HL. Acquired generalized hypohidrosis/anhidrosis with subclinical Sjogren's syndrome: report of a case with diffuse syringolymphoid hyperplasia and lymphocytic sialadenitis. J Am Acad Dermatol. 1996 Aug;35(2 Pt 2):350-2.
* Shoaib BO, Patten BM. Human adjuvant disease: presentation as a multiple sclerosis-like syndrome. South Med J. 1996 Feb;89(2):179-88.
* Cuellar ML, Gluck O, Molina JF, Gutierrez S, Garcia C, Espinoza R. Silicone breast implant--associated musculoskeletal manifestations. Clin Rheumatol. 1995 Nov;14(6):667-72.
* Lappe MA. Silicone-reactive disorder: a new autoimmune disease caused by immunostimulation and superantigens. Med Hypotheses. 1993 Oct;41(4):348-52.

ALTERNATIVE MEDICINE: For more information see:
http://www.mercola.com/2004/apr/7/sinus_infections.htm
Fungus May be Causing Your Sinus Infections--Here's What Can Help By Dr. Joseph Mercola with Rachael Droege: About 37 million Americans suffer from sinusitis, an inflammation of the nasal sinuses commonly known as a sinus infection, each year and for many this is a chronic problem that can seriously affect the quality of your life. Most cases of sinusitis are treated with antibiotics, which may help to cover up symptoms in the short-term but are a disaster when used in the
long-term.

Sinusitis can be acute or chronic, and can last for months or years if not addressed. Symptoms vary for each type but can include:

Runny nose
Nasal Congestion
Thick, colored nasal drainage
Cough
Head congestion
Headache
Post-nasal drip
Facial pain or swelling
Toothache
Fatigue
Diminished sense of smell and taste
Fever

And despite constant treatment with antibiotics, many people's sinusitis continues to return. According to the American Academy of Allergy, Asthma & Immunology, not only is sinusitis one of the most expensive disorders in the United States, but also its prevalence is on the rise, indicating that the common treatment methods are not getting to the root of the problem.

So what is the root of the problem? Researchers have found that most cases of chronic sinusitis are not caused by infection but are actually an immune disorder caused by fungus. In a 1999 study, the researchers discovered that fungal organisms were present in the mucus of 96 percent of patients who had surgery for chronic sinusitis, and inflammatory cells were clumped around the fungi, which meant the condition was an immune disorder caused by fungus.

Fungus and mold spores are in the air all the time and are commonly inhaled so most people have fungi lodged in the mucus lining of the sinuses. However, only people who are prone to chronic sinusitis will experience an immune response to the fungi that results in the symptoms of sinusitis.

They took the research a bit further and in the next study found that a fungicide was effective in decreasing inflammation and nasal swelling among participants suffering from chronic sinusitis. The researchers are hoping the study will lead to the development of new antifungal medications to treat the condition.

Although antifungals may be more effective than antibiotics--antibiotics make fungal infections worse--there are other steps you can take to lessen your risk of sinus infections by getting at the underlying cause.

Make Your Body Less Hospitable to Fungus As the body attempts to destroy the fungus, the immune system damages the sinus membranes, which causes the symptoms of sinusitis, the researchers say. To combat the fungus and prevent the immune system reaction, you'll need to create an environment that makes it more difficult for fungus to thrive.

Here are the top ways to do this:

Avoid Eating Sugar or Grains: Fungus feeds on sugar and grains (which break down to sugar in your body), so reducing or eliminating these foods is necessary to keep fungus under control.

Eat Raw Garlic: Garlic's anti-fungal properties are excellent for reducing fungal infections. Garlic must be fresh in order for it to be beneficial because the active ingredient is destroyed within one hour of smashing the garlic. For this reason garlic pills are virtually worthless and should not be used. When you use the garlic, compress it with a spoon prior to swallowing it, or put it through your juicer to add to your vegetable juice.

Eat Coconut Oil: Coconut oil is rich in lauric acid, which is known for being antiviral, antibacterial and antifungal. However, be careful with which oil you choose, as many coconut oils contain fungal toxins. This is because they are commonly made with copras, or dried coconuts, which are often contaminated with mycotoxins. So in order to fully enjoy the benefits of this coconut oil, you will want to be sure that you find a company that uses only fresh coconuts to make their oil, like the Tropical Traditions virgin coconut oil on this site.

Avoid Eating the Top 10 Mycotoxic Foods: Here's a list of the top 10 foods that are contaminated with mycotoxins (fungal toxins) that need to be avoided. Alcoholic beverages, the yeast causes the problem. 2) Corn, universally contaminated with fumonism and other fungal toxins such as aflatoxin. 3) Wheat, not only often contaminated with mycotoxins, but so are the products made from wheat, like breads, cereals, pasta, etc. Pasta may be the least offensive form of grains, since certain water-soluble toxins are partially removed and discarded when you toss out the boiling water it was cooked in. Unfortunately, traces of the more harmful, heat-stable and fat-soluble mycotoxins, such as aflatoxin, remain in the grain. 4) Barley, similar to other grains that can be damaged by drought, floods and harvesting and storage processes, barley is equally susceptible to contamination by mycotoxin-producing fungi. 5) Sugar, not only are sugar cane and sugar beets often contaminated with fungi and their associated fungi, but they, like the other grains, fuel the growth of fungi. Fungi need carbohydratessugarsto thrive. 6) Sorghum, used in a variety of grain-based products intended for both humans and animals. 7) Peanuts, 24 different types of fungi are colonized on the inside of peanuts. The molds that grow inside cause mycotoxins. 8) Rye, same as for wheat and other grains. 9) Cottonseed, typically found in the oil form, but also in the grain form for many animal foods. 10) Hard cheeses, which often show mold. When mold is present, so are mycotoxins. Gouda cheese is not hard cheese, and a much healthier alternative.

Naturally, this means that you should not eat fungus, which means mushrooms and myco-protein products.

Exercise: Physical activity causes the sinuses to expand and stimulates air circulation and cleansing mucus to move through the sinuses. This will help to clear out any particles that are contributing to the irritation. Similarly, a past study found that humming increases the amount of air exhaled from the nose and facilitated the exchange of air from sinuses into nasal passages, which could lower the risk of sinus infections if done routinely.

Clear Your Sinuses Without Medication: To help clear sinuses that are congested, you can consider washing the nasal cavities with a solution of salt and room temperature purified water. Breathing in certain essential oils can also be beneficial.

COMMENTARY: Included without comment: Brazilian Firm Pumps Up Silicone Breast Business: RIO DE JANEIRO: Exuberant breasts exposed by beauty queens at Rio de Janeiro's Carnival or those stretching scanty bikini tops on Brazil's beaches often have little to do with nature's generosity. In fact, a small plant on the ugly outskirts of Rio de Janeiro that produces transparent silicone implants stands behind most of the so-called turbo-charged cleavages in the tropical country famous for its cult of body beautiful. Apart from endowing with silicone eight out of every ten Brazilian women who choose breast enlargement surgery, Silimed, as the Brazilian manufacturer is called, exports 65 percent of its output and is the world's No. 3 supplier of breast implants. This summer, Silimed will open a new plant capable of producing 500,000 silicone packs annually, more than three times the size of its current capacity of 150,000 pieces, as it prepares an assault on the U.S. market -- the world's biggest. Using certified raw materials imported from the United States, Silimed mostly makes breast implants but also facial, buttocks and even testicle implants of silicone gel. "We are going to make a real go on the U.S. market in 2004 or 2005 ... We can take 10 percent of their market easily from the very start," said Silimed President Antoine Robert, a Frenchman who has lived in Brazil since 1974. For now, however, Silimed's implants are undergoing clinical studies for the U.S. market. A total of 1,000 patients will have to be studied over two years to gain the approval. United States consumers buy an estimated 350,000 implants a year, making up 60 percent of global demand. In Brazil, 25,000 to 27,000 women undergo breast augmentation annually. Silicone packs with Silimed's logo were used on some 19,000 women here last year.

The Holistic Mystic
"Alternative" Is Relative(c)
by Lonny Brown, Ph.D. WHAT'S IN A NAME?
Alternative Health is big news these days, but the term is misleading. Herbology, for instance, is thousands of years old, but to many sounds novel because our society has a short memory. Two generations ago, all medicines came from plants. Now they come from test tubes, yet we call the far older approach "alternative." Within a few decades, western medicine has "normalized" synthetics, and all but discarded centuries of accumulated indigenous knowledge about valuable, natural medicines.

When I first moved to New England in the early '70's, midwifery and home-birth was still a underground, quasi-legal movement. Today,
nurse-midwives, family-assisted home-birthing, and breast feeding are recommended as healthier by the same establishment that denigrated them a few years ago. Likewise, chiropractic, massage, yoga, meditation, and vegetarianism have all gone from fringe to chic within the past two decades.

As alternatives go mainstream, the word quickly loses its meaning. An alternative term for "alternative" is "non-traditional" but that's relative too. To many of us, "traditional" medicine means MD's and drug-stores. To native Americans, shamanism is traditional. I prefer terms like complementary medicine, or integrative therapy. This implies cooperation - not competition - with established methods. The new, holistic over-view is like a larger umbrella covering our previous medical knowledge, not excluding it.

A PLACE FOR HIGH-TECH
What we have come to think of as conventional medicine is a high-intervention, bio-analytical form of allopathy. It relies primarily on chemical drugs, surgery, radiation, and other high technology. It excels at symptomology and exacting diagnosis. It is the system of choice for infectious and life-threatening diseases, organ failure, traumatic injuries, acute pain and emergencies. In other words, if you have a broken leg, forget the home remedies and go get it repaired by the best medical technicians!

However, if you suffer from chronic fatigue, hypertension, digestive disorders, colds, tension headaches, back pain, allergies, complexion problems, or the numerous other unfortunate consequences of stress, junkfood, overweight, substance abuse, lack of exercise, or pollution, neither the hospital nor your doctor will be able to offer much help. First you have to do your own health-care homework.

A GOOD DOCTOR
Eighty percent of modern America's medical complaints are preventable life-style or stress-related disorders. The holistic practitioner's job is to educate and encourage people to take care of themselves. He or she does not diagnose, prescribe, or cure, but rather coaches. An adjunct practitioner, she takes some of the load off your Doctor, who does not have the time to review your lifestyle, assess you work environment, analyze your diet, counsel your addictions, examine your relationships, teach you stress management, monitor your fitness program, or direct you to further resources.

Supposing you discover - while taking medications to lower your blood pressure, reduce pain, or get to sleep - that you can learn relaxation with bio-feedback, a low-risk, inexpensive alternative. Any good doctor would support this worthwhile goal (although not all offer it). In this case an "alternative" makes a good co-therapy, or may just become the treatment of choice.

We should also be aware of how commercialism and the media co-op and corrupt health terminology. The word "organic" finally has a federally-defined legal definition, but not so for terms like "natural," "holistic," or even "herbal." Unfortunately and all too often, these have become meaningless
marketing tools.

WHATEVER WORKS
The New England Journal of Medicine, has reported that millions of Americans spend billions of their own dollars on health services not covered by medical insurance. The fact that 80% of these determined health consumers did not tell their regular physicians of their decision to seek alternatives reveals a crises of confidence in the establishment.

The government has recognized the issue by forming a special Office of Alternative Medicine at the National Institutes of Health to investigate the efficacy of homeopathy, acupuncture, massage, apitherapy, magnetic therapy, and other "traditional" modalities. But the surge of acceptance of new (and old) approaches need not lead to a turf war between MD's and alternative practitioners. In a shrinking world and a time of information explosion, what will prevail is what works. Twenty-first-century medicine will witness the inevitable and long-overdue reconciliation of science and art, east and west, old and new, body, mind and soul. The resulting Co-operative Medicine, will naturally allow for all the diverse and mysterious ways in which healing occurs.

Lonny J. Brown, Ph.D. is the author of "Self-Actuated Healing" (Amazon.com),
"Meditation - Beginners' Questions & Answers" www.SelfHelpGuides.com), and "Enlightenment In Our Time" www.BookLocker.com/LonnyBrown), and his writings on holistic health have appeared on AOL's Alternative Medicine Forum and in Alternative Health Practitioner, Yoga Journal, and many other progressive publications. Dr. Brown offers holistic health counseling by email, phone, and in person in the Monadnock region of New Hampshire, and teaches meditation, mind/body healing, and stress reduction courses at hospitals, schools and businesses throughout the US. His Web site also features essays, tapes, books, and links to a variety of integrative health sources.www.holistic.com/lonny lonny@holistic.com lonnybrown@aol.com

http://www.ananova.com/news/story/sm_1030214.html
US servicemen and women are being offered free plastic surgery, including breast enlargements, on the taxpayer. The New Yorker magazine reports that members of all four branches of the US military and their families can get face-lifts, breast enlargements, liposuction and nose jobs for free. "Anyone wearing a uniform is eligible," Dr Bob Lyons, chief of plastic surgery at Brooke Army Medical Centre in San Antonio told the magazine. Soldiers needed the approval of their commanding officers to get the time off. Between 2000 and 2003, military doctors performed 496 breast enlargements and 1,361 liposuction surgeries on soldiers and their dependents, the magazine said . The magazine quoted an army spokesperson as saying: "The surgeons have to have someone to practice on."

THE OPINIONS EXPRESSED IN THIS NEWSLETTER ARE THOSE OF THE EDITOR AND ANY CONTRIBUTORS AND ARE NOT TO BE CONSTRUED AS MEDICAL OR LEGAL ADVICE. ANY ARTICLES OR INFORMATION SUBMITTED MAY BE EDITED BECAUSE OF SPACE, CONTENT OR GRAMMATICAL ERRORS.
LYNDA ROTH, EDITOR

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