AVAILABILITY OF IMPLANTS.

Why is access to silicone gel-filled breast implants presently restricted?

On April 10, 1991, FDA asked the manufacturers to submit evidence that silicone gel-filled breast implants were safe and effective. However, they were unable to provide FDA with this information. This did not necessarily mean that the 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 breast implants could not be approved, and therefore gel-filled implants were removed from the market.

Currently, silicone gel-filled breast implants may be available to certain women only through a clinical study conducted under the Investigational Device Exemptions (IDE) regulations or an FDA-approved adjunct study.

How are breast implants studied under the Investigational Device Exemption (IDE)?

A manufacturer may conduct a study of silicone gel-filled breast implants or other alternative breast implants under an IDE study approved by FDA. Women participating in such a study would receive their breast implants for the indication(s) specified in the study protocol (study plan).

The IDE allows the manufacturer to study the device on a specified number of human patients according to the protocol without meeting all FDA requirements for marketed devices. Before the study begins, FDA reviews and approves the protocol to help assure that the resulting data will be meaningful and that patients will not be exposed to unreasonable risks. Under the law, FDA cannot acknowledge the existence of any study conducted under the IDE unless the company publicly announces the existence of the study. Likewise, the results of studies conducted under an IDE are not publicly releasable by FDA if the manufacturer has not made the data publicly available. Generally, these data are used as the basis for a future application to market the device.

Each patient who participates in an IDE study must give informed consent, and an Institutional Review Board (IRB) must oversee the study. An IRB is composed of scientists, health professionals and community members who do not have a conflicting interest in the outcome of the study. The IRB oversees research and protects the rights, safety and welfare of participating patients.

Recently, FDA gave approval for an IDE study of silicone gel-filled implants for augmentation, reconstruction, and revision (replacement), for a limited number of women at a limited number of sites, to be conducted by one manufacturer, McGhan Medical Corporation. This study is intended to provide scientific data on the safety and efficacy of silicone gel-filled implants. It is the only means by which silicone gel-filled implants are currently available for augmentation. According to the study protocol, each woman will be followed for at least ten years post-implantation.

For information on participating in a clinical trial with an approved IDE, contact the sponsor of the study.

How are breast implants available under an adjunct study?

Under the law FDA may extend its review period of devices already on the market if the agency determines that 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 gel-filled breast implants, and the known, potential and suspected risks, FDA reached the conclusion that silicone gel-filled breast implants should continue to be available for women seeking breast reconstruction or revision of an existing silicone gel-filled implant. FDA extended the review period for silicone gel-filled implants for the purpose of reconstruction. Therefore, silicone gel-filled breast implants are available when indicated for reconstruction for women with special medical needs or for revision.

Only women with special medical needs can obtain silicone gel breast implants in one of the adjunct studies. Those eligible women include those who have had breast cancer surgery, a severe injury to the breast, a birth defect that affects the breast, or a medical condition causing a severe breast abnormality. Additionally, those who need to have an existing silicone gel-filled implant replaced for medical reasons, such as rupture of the implant, are also eligible. Women who want silicone gel-filled implants for breast augmentation (enlargement) cannot be enrolled in these studies.

At this time, two manufacturers, Mentor Corporation and McGhan Medical Corporation, have been approved by FDA to conduct adjunct studies on silicone gel-filled implants. According to the study protocols, each woman will be followed for at least five years.

How can a woman enroll in an adjunct study of silicone gel-filled implants?

To enroll in an adjunct clinical study of silicone gel-filled breast implants, a woman must meet the previously mentioned criteria of medical need. She should contact the surgeon she chooses to perform her implant surgery.H The surgeon will determine the woman's eligibility for the study and contact the manufacturer. The surgeon must certify to the manufacturer that the woman qualifies for the implant, then make the necessary arrangements with the implant manufacturer. For further information on enrolling in an adjunct study, a woman or her doctor may contact Mentor Corporation or McGhan Medical Corporation. (See Resource Index.)

What is the status of saline-filled breast implants?

Saline-filled implants are currently available for augmentation, reconstruction and revision to anyone who wants them.

The manufacturers of saline-filled breast implants -- which contain salt water rather than silicone gel -- were notified by FDA in January 1993 that the agency will require data on their products' safety and effectiveness. While the companies are conducting the required studies, saline-filled breast implants remain on the market. FDA believes that saline implants present a lower degree of risk than gel-filled implants, because leakage or rupture would release only salt water into the body.

On December 23, 1994, FDA announced that companies marketing saline-filled breast implants are required to enroll patients promptly in clinical trials to demonstrate the safety and effectiveness of these devices. In addition to trials, the companies are required to report laboratory, animal, and clinical data to FDA and disseminate revised patient information. The reports to FDA will be made in stages. For additional information about the clinical trials, a woman or her doctor may contact the manufacturers of saline-filled breast implants. As of September 1998, five companies have saline-filled breast implants on the market: Mentor Corporation, McGhan Medical Corporation, Hutchinson International, Silimed L.L.C., and Poly Implant Prostheses.

What information is being collected on saline-filled breast implants?

Manufacturers are conducting both laboratory and clinical studies to assess the safety and effectiveness of saline-filled breast implants. Laboratory studies include animal studies and mechanical bench testing to assess the biocompatibility and long-term performance of these implants. Clinical studies are assessing both the complications (rupture, infection, capsular contracture, systemic effects, etc.) and benefits (quality of life, etc.) experienced by women enrolled in the study.

Although many of these studies have been completed, the data were submitted to the FDA under a premarket approval (PMA) application and are therefore confidential unless publicly released by the manufacturers.

It is expected that at the end of 1998, FDA will call for the submission of PMAs for saline breast implants. At that time, manufacturers of saline implants will submit studies on the topics above as part of their PMA submissions to FDA. The law requires that PMAs for these pre-Amendments devices be approved in order for the manufacturers to continue to sell these products. FDA will evaluate the data submitted to determine if the scientific evidence demonstrates the safety and effectiveness of each manufacturer's saline-filled breast implants.

Are other types of breast implants available besides silicone gel-filled and saline-filled implants?

Currently, there are no alternative breast implants approved for marketing. An alternative breast implant can only be made available through an IDE clinical study.

LipoMatrix Inc., a subsidiary of Collagen Aesthetics, Inc. (DBA Collagen Corporation), was testing an implant which has a silicone shell filled with purified soybean oil (Trilucent implant). Approximately 470 women (approximately 200 of who are in the USA) were enrolled in an IDE clinical study to evaluate the safety and effectiveness of the implant. In 1997, the manufacturer ceased new patient enrollment into the IDE. The IDE patients are being evaluated and no new clinical studies are planned for this breast implant.

In summary, what is the regulatory status of the breast implant manufacturers?

At the time of publication, breast implants were available from the following manufacturers: McGhan Medical and Mentor Corporations make both silicone gel and saline-filled implants; Hutchinson International, Silimed L.L.C., and Poly Implants Prostheses market saline-filled implants.

On May 6, 1998, Mentor Corporation and its subsidiary, Mentor Texas, signed a consent decree of permanent injunction, promising that the company would manufacture its breast implants in compliance with the Quality System Regulation. The quality system regulation is critical in helping to assure that medical devices are consistently high in quality and are safe and effective. FDA is permitting Mentor to continue marketing its breast implants because the deficiencies in Mentor's manufacturing process have not been shown to result in a significantly increased risk to women who have received this company's breast implants.