Thu, 19 Oct 2006 22:49:20 EDT
FDA APPROVES CLINICAL STUDIES OF SILICONE BREAST IMPLANTS
We have been receiving inquiries about the status of silicone gel-filled breast implants. On July 24, FDA granted approval to Mentor Corporation of Santa Barbara, Calif., to begin clinical studies of these implants. The agency's action will provide access to silicone gel implants, via participation in the studies, to all women who desire them for reconstruction after mastectomy or serious injury and who meet certain criteria. It may be several weeks, however, before the implants are actually available, due to final preparations for the studies by Mentor.
The following can be used to answer public inquiries.
On Jan. 6, 1992, FDA called for a moratorium on the use of silicone gel breast implants until new information on their safety could be reviewed by an advisory panel (see P92-1). On Feb. 20, the panel recommended that breast implants be made available only on a limited basis under carefully controlled clinical studies (see T92-9). On April 16, FDA Commissioner David A. Kessler, M.D., adopted that recommendation, stating that more studies were needed to answer basic questions about the safety of silicone gel breast implants before they could be commercially marketed (see P92-11). Mentor's studies will attempt to find answers to some of these questions, including the rate of rupture, infection and contracture. Participants will be watched closely by their doctors after surgery and will be required to have periodic checkups for five years.
To be eligible, women must be 18 years old, have a medical need for breast reconstruction for which saline-filled implants are not suitable and be willing to provide basic personal information for the study.
Participants may include:
Women who need reconstruction after mastectomy or other treatments for cancer, or after mastectomy for other medical reasons. This includes cancer patients who previously had breast reconstruction with saline implants or their own tissue with unsatisfactory results.
Women who need reconstruction because of other severe breast or chest deformities, such as those resulting from congenital or developmental problems or medical-surgical complications. (Because "severe" is a subjective assessment, the physician must judge the severity of the deformity and certify that there is a medical need for corrective surgery.)
Women who have or have had silicone gel implants and for whom replacement is medically necessary. The studies exclude women who are pregnant or nursing; have an abscess or infection; have been diagnosed with lupus or scleroderma; have uncontrolled diabetes or other disease which affects healing; have incompatible tissue characteristics; or who are an unwarranted surgical risk.
In order to enroll in the studies, women must agree to read and sign a detailed informed consent form, get follow-up examinations after surgery and periodically for five years and consider enrolling in a patient registry. At least 3,000 surgeons are expected to participate as clinical investigators in the study. These surgeons must provide a special consent form to each patient, certify that the patient meets all the criteria and that saline implants are not a viable alternative, notify Mentor of all breast implants implanted and provide information needed for the patient registry. They must also keep comprehensive records of the patient's health prior to the operation and details of the surgery and results of follow-up checkups, including any complications. In addition, surgeons must give each patient a record of the implants she received, including the brand and model, identifying characteristics and implant placement.
Each surgeon's participation must be approved by an institutional review board. At this time, Mentor is the only firm that has received FDA approval to conduct clinical studies of silicone breast implants. Other manufacturers may have similar clinical studies approved at a later date. Also at a later date, silicone gel-filled breast implants will be available in other studies that will include a limited number of women who desire implants for breast enlargement as well as those who need them for reconstruction. The studies will focus on additional safety questions and on the psychological benefits of implants. Only enough women to answer the scientific questions posed will be allowed to enroll in these studies. Women who want to enroll in the current studies should contact their doctor. Physicians can obtain a list of participating investigators or additional information from the Mentor Corporation.
They may write or call
Mentor at:
Mentor Corporation
Clinical Studies Monitor
5425 Hollister Ave.
Santa Barbara, CA. 93411
1-800-525-6747
Saline breast implants are still on the market and are not part of thecurrent studies.FDA will soon be notifying manufacturers that they will be required to submit safety and effectiveness information for these products.
