1) What type of study was the Mayo Clinic Study, reported In the New England Journal of Medicine?

The Mayo Clinic Study was a review of medical records of women in Olmstead County, MN; 749 of whom had breast implants; 1,498 of whom did not have implants. The purpose was to examine the risk of connective tissue diseases in women with breast implants.

2) What kind of breast Implants had the women received?

78.3% Of the implants were silicone gel, 9.6% were polyurethane-coated implants, 6.7% were a combination of silicone and saline, and 5.2% were saline in a silicone shell.

3) What diseases were studied?

The authors defined connective tissue disease (CTD) as a group of disorders that includes rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, dermatomyositis, polymyositis, systemic sclerosis, ankylosing spondylitis, psoriatic arthritis, polymyalgia rheumatica, vasculitis, arthritis associated with inflammatory bowel disease, and polychondritis. Other disorders considered included Hashimoto's thyroiditis, primary biliary cirrhosis, sarcoidosis and cancer other than breast cancer.

4) What were the findings of the study?

The authors stated, "We found no association between breast implants and the connective tissue diseases and other disorders that were studied".

5) Did the authors examine the risk of ruptures, contracture, infections, scarring, local inflammation or deformity associated with breast implants?

No.

6) I have been diagnosed with atypical connective tissue disorder because of my breast implants, Does this study indicate that my illness was caused by something else?

No. This study's ability to detect CTD's was limited by the small sample size and did not look for connective tissue disorders such as muscle pain, joint pain, weakness, or fatigue.

7) Should we conclude, as the newspapers reported, that this study is "reassuring" to women with breast implants?

No. A close examination of the Mayo Clinic study reveals that, unfortunately, such a conclusion is not warranted. One problem with the study is that, because only 749 women with implants had their records examined, the ability of the study to detect a significant doubling of the risk of CTDS among women with breast implants was very low, only 31% (this is described as the power of the study). The odds are strongly against this study being able to detect a significant increase in these risks.

8) So, did the authors come to the wrong conclusion?

No, but their conclusion was misleading. They should have reported that because of the limited size, the power of the study was weak. Such negative findings should not be taken as an assurance that breast implants are not causing CTD's. When the negative results of any study are reported, it is imperative to put them into perspective by assessing the power of the study as a means of determining the significance of the negative findings.

9) Are there any other weaknesses in the study?

Yes. The women who had breast implants were only followed by the researchers for a mean of 7.8 years. In many women with implants, CTD's do not become noticeable until 10 or even 15 years after implantation. This study would not detect cases of CTD in these women.

10) How was the study funded?

The study was funded in part by the Plastic Surgery Education Foundation, which is an arm of the American Society of Plastic and Reconstructive Surgeons, which has lobbied to keep the implants on the market.

11) Will this study affect the proposed global settlement between breast implant manufacturers and woman injured by implants?

No. A spokeswoman for Dow Coming, the largest contributor to the settlement, was quoted in the Wall Street Journal of June 16 as saying 'It [the Study] won't derail the settlement.'

12) What kind of study is needed to determine the quantitative risks of CTD's and other injuries associated with breast implants?

Because some of the diseases, such as scleroderma, are rare, a large multicenter study, preferably a prospective study (One where women are enrolled as they receive the implants, for later study) is needed. In fact, the FDA requires all women who receive silicone gel implants to be enrolled in such studies. The saline implants, however, are still being implanted in women without requiring their enrollment in studies. Next best would be a much larger retrospective study (a study looking at women who have received implants in the past), such as a study being carried out by the National Cancer Institute, which has enrolled 12,000 implanted women.

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