Breast implant information

Silicone-Filled Breast Implants

*Caution: Silicone Filled breast implants are limited distribution devices and are only available by or on the order of a licensed physician as part of an Allergan McGhan Medical Clinical Study

For some women, breast implants can improve their quality of life. Some breast cancer survivors believe that getting breast implants can be an important part of their recovery. However, other women find external breast forms to be satisfactory. Reconstruction options include breast implants or surgery using tissue from a patient's own abdomen, back, or buttocks to form a new breast. This surgery requires sufficient fat tissue and a longer operation, and like any other procedure, it is not always successful. For each woman, whether her goal is augmentation or reconstruction, the benefits may be different. With your physician's advice, you must decide whether or not you wish to accept the possible risks in order to achieve the expected results.

Breast implant surgery presents the same general risks associated with anesthesia as any other surgery. After the surgery, there are other special risks related to silicone-filled breast implants.

Availability of Silicone-Filled Breast Implants On April 10, 1991, FDA asked the manufacturers to submit evidence that silicone-filled breast implants were safe and effective. However, much of the information was not available. This did not necessarily mean that the breast implants were unsafe, but it did mean that FDA could not, as the law requires, confirm their safety.

With insufficient data on safety and effectiveness, FDA determined that silicone-filled breast implants could not be approved and could not be marketed for the purpose of breast augmentation in healthy women. However, under the law, FDA may extend its review period of devices already on the market if the agency determines that a continued availability of the device is necessary for the public health. In April 1992, after a careful evaluation of the public health need, the alternatives to silicone-filled breast implants, and the known, potential and suspected risks, FDA reached the conclusion that silicone-filled breast implants should continue to be available for women seeking breast reconstruction because of their public health need.

Because there are FDA concerns about the possible short-term and longterm effects of silicone-filled breast implants, FDA has limited access to these devices to women who are enrolled in a clinical study sponsored by the manufacturer and approved by FDA. Each patient must give informed consent, and the study must be overseen by an Institutional Review Board. An Institutional Review Board is composed of unbiased scientists, health professionals and community members who oversee and protect patients participating in a clinical study.

How to Enroll in a Study on Silicone-Filled Breast Implants To enroll in a study on silicone-filled breast implants, you must meet certain criteria. You should first contact the physician you choose to perform your breast implant surgery. A list of participating physicians can be obtained by calling McGhan Medical at 800.624.4261. The physician will determine your eligibility for the study and contact McGhan Medical to make the necessary arrangements. The physician must certify to McGhan Medical that you qualify for the breast implant, then make the necessary arrangements with McGhan Medical. You or your physician may contact McGhan Medical directly at 800.624.4261 for further information.

Your Expectations

Your consideration of breast implants should be based on realistic expectations of the outcome. To help you get an idea of what results may be possible, request "before and after" pictures of patients who have had this surgery from your physician. Keep in mind, however, that there is no guarantee that your results will match those of other women. Your results will depend on many individual factors, such as your overall health, chest structure and body shape, healing capabilities (which may be hindered by radiation and chemotherapy, smoking, alcohol and various medications), bleeding tendencies, prior breast surgery(ies), infection, skill and experience of the surgical team, and the type of surgical procedure.