1. Fibrous Capsular Contracture

Fibrous capsular contracture, the formation of a constricting fibrous layer around the prosthesis, is the most common risk associated with breast augmentation and reconstruction. Capsular contracture may result in excessive breast firmness, discomfort, pain, disfigurement, and displacement of the implant. This condition occurs most commonly within the first few months following surgery. Degrees of capsular contracture have not been quantitatively defined. The rate of clinically significant contracture has been cited as between approximately 3 and 45 percent.

Although several etiological factors have been suggested, including hematoma, infection, foreign body reaction, and radiation, no single factor has been demonstrated to be the sole cause of contracture. The etiology of contracture is not understood.

2. Deflation

Deflation of the device results from partial or total loss of the contents due to puncture, rupture or other failure of the shell, or a faulty valve. Deflation results in the loss of shape of the prosthesis, which may cause deformity of the breast and require surgical intervention to correct.

3. Infection

Infection, a risk of any surgical implant procedure, is associated with the use of silicone inflatable breast implants. As in any implantation procedure, cornpromised device sterility and surgical techniques may be major contributing factors to this risk. Other factors specifically related to breast implants have been identified which may increase the risk of infection associated with this device. Burkhardt, et al. have concluded from their studies that Staphylococcus Epidermidis, which has been cultured from uninfected

breast glands, may cause subclinical infections of the periprosthetic area if the ductal system is disrupted during the surgical procedure. It has been suggested that this may also contribute to the early development of capsular contracture

4. Interference With Early Tumor Detection

Several reports have suggested that the presence of silicone inflatable breast implants may interfere with standard mammography procedures used to screen patients for breast cancer. The presence of the implant can produce a shadow on the radiograph that may reduce visual clarity of a significant portion of the breast. Furthermore, there is greater reduction of transmission of X-rays through the saline filler than through tissue. In addition, the presence of the implant compresses overlying breast tissue particularly fat,

creating a denser organ with less radiographic contrast. Compression obliterates the fine trabecular pattern of the breast, making architectural distortions difficult to see in a radiograph.

The risk of interference with early tumor detection could potentially affect a large number of patients, because most recent predictions indicate that approximately 10 percent of women in the United States will develop breast cancer during their lifetime.

5. Human Carcinogenicity

Carcinogenesis has been widely discussed as a reputed risk secondary to implantation of any material. Evidence from the literature indicates that in animal studies, different forms of silicone have been associated with various types of cancer. Cases of several types of cancer in humans have been reported in association with various forms of implanted silicone.

6. Human Teratogenicity

Teratogenesis includes the origin or mode of production of a malformed fetus and the disturbed growth processes involved in the production of a malformed fetus. Studies using silicone fluid in animals have been minimal and yield contradictory and inconclusive results. Prolonged contact with the silicone membrane and its components might present a potential risk of teratogenicity in humans.

7. Adverse Immunological Effects and/or Connective Tissue Disorders

Adverse immunological effects and/or connective tissue disorders may be a serious risk associated with the implantation of a silicone inflatable breast prosthesis. These problems have been discussed related to the use of silicone gel-filled prostheses and silicone injections in augmentation mammaplasty. There are clinical reports of several patients who have undergone augmentation mammaplasty with silicone gel-filled breast prostheses and who have presented with connective tissue disorders. Because the silicone inflatable breast prosthesis may contain a similar elastomer rubber shell, prolonged contact with this prosthesis presents a potential risk of adverse immunological effects and/or connective tissue disorders in humans.

8. Calcification

Calcification of the fibrous capsule surrounding the implant involves the deposition of mineral salts in the capsule and may compromise interpretation of mammagraphic films and contribute to diagnostic errors or delays in diagnosis of cancerous lesions.

9. Biological Effects of Silica

Amorphous (fumed) silica is bound to the silicone in the shell and may be fibrogenic. Fumed silica and the silicone shell each elicit cellular responses in rats. The biological effects of silica present a potential risk.

I have read this and have had my questions answered as a prerequisite to being implanted with saline-filled silicone implants.

Signature____________________________________________

Date: ___________________________

Source: Food & Drug Administration Letter

Witness________________________________________

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