⁶⁵Sketch from Inamed patient labeling at FDA's website at http://www.fda.gov/cdrh/breastimplants/.
⁶⁶Sketch from Inamed patient labeling at FDA's website at http://www.fda.gov/cdrh/breastimplants/.

TIMELINE OF BREAST IMPLANT ACTIVITIES

• May 28, 1976: The Medical Device Amendments were enacted, giving FDA authority to regulate medical devices such as breast implants, which were already on the market.

• July 23, 1976: The FDA General and Plastic Surgery Devices Panel (the Panel) recommended that breast implants be placed in class II, requiring general controls and performance standards. Under the law, there are three regulatory categories for medical devices. Class I devices are usually simple devices whose risks can be controlled by labeling and the manufacturing process. Class II devices require additional measures, called special controls, to control risks. Special controls may include performance standards, postmarket surveillance studies, user education, or other measures. If there is a lack of information about whether a device is safe and effective, it is put into class III, and the highest level of premarket review is required. Class III devices include innovative (creative), medical breakthrough, new technology devices, and devices with poorly established or questionable safety and effectiveness.

• January 19, 1982: Because of some reports of adverse events in the medical literature, FDA announced a proposal to place breast implants in class III. Class III devices have strict controls for safety and effectiveness.

• June 24, 1988: FDA classified all breast implants into class III. After a prescribed waiting period of 30 months, FDA could require the submission of PMAs in which manufacturers present data showing the safety and effectiveness of these devices.

• January 6, 1989: FDA published a notice of intent to require submission of PMAs for saline-filled and silicone gel-filled breast implants.

• January - March 1989: An unpublished study showed that polyurethane foam, which was used as a coating on certain types of silicone gel-filled breast implants, would degrade and release 2-toluene diamine (TDA), a chemical known to cause cancer in animals, under conditions of high temperature and alkalinity (high pH). FDA requested specific information from the manufacturer about the chemical make up and safety testing of polyurethane foam. Shortly afterwards, the manufacturer of polyurethane foam-coated breast implants removed them from the market.

• May 17, 1990: FDA issued a proposed 515(b) regulation (call for safety and effectiveness data) in the Federal Register on silicone gel-filled breast implants.

• February 1-2, 1991: FDA sponsored a Conference on Silicone in Medical Devices. This was an exchange of scientific information and views on the applications of silicone in medical devices.

• April 10, 1991: FDA published a final 515(b) regulation in the Federal Register that required manufacturers of silicone gel-filled breast implants to submit PMAs with data showing a reasonable assurance of safety and effectiveness of the implants by July 9, 1991.

• June 1991: FDA required the company of polyurethane foam-coated breast implants to conduct research on the material. In taking this action, FDA made the first use of new postmarket surveillance authority under the Safe Medical Devices Act of 1990.

• July 31, 1991: The Panel reviewed FDA's risk assessment of polyurethane foam coating. The Panel found that the risk of cancer, if any, appears small and would very likely be outweighed by the surgical risk involved in removing a polyurethane-coated breast implant.

• August 22, 1991: FDA determined that PMAs submitted by three companies of silicone gel-filled breast implants did not contain sufficient data to warrant a full review.

• September 26, 1991: FDA issued a Notice in the Federal Register requiring distribution of information to patients on the risks associated with saline-filled and silicone gel-filled breast implants.

• November 12-14, 1991: FDA convened the Panel to consider whether the PMA data received from the companies was sufficient to establish that the silicone gel-filled breast implants are safe and effective. Despite the lack of data, the Panel voted unanimously (complete agreement) to advise FDA that the implants filled a public health need for breast reconstruction and revision for medical or surgical reasons and that the implants should continue to be available while the companies collected additional data.

• January 6, 1992: FDA called for a voluntary moratorium (delay) on the use of silicone gel-filled breast implants until new safety information could be thoroughly reviewed by the Panel.

• February 18, 1992: The Panel met again to review new information on silicone gel-filled implants. This included case reports of autoimmune diseases, information not included in the companies' original submissions to FDA, and evidence that some early models may have leaked excessively.

• March 19, 1992: Dow Corning withdrew from the silicone implant market but continued to supply gel to one implant company.

• April 16, 1992: FDA lifted the voluntary moratorium on breast implants. FDA also announced its decision to allow access to silicone gel-filled breast implants only under controlled clinical studies for reconstruction after mastectomy, correction of congenital deformities, or replacement of ruptured silicone gel-filled implants due to medical or surgical reasons. Until the these clinical studies (adjunct studies) could be submitted and reviewed, FDA authorized temporary limited distribution of silicone gel-filled implants for reconstructive patients on an urgent need basis with a very detailed informed consent form. FDA denied applications for using silicone gel-filled breast implants for augmentation but planned that the companies would later conduct clinical trials that would include a limited number of augmentation patients (core or IDE studies).

• July 24, 1992: FDA approved Mentor Corporation's adjunct study protocol for silicone gel-filled breast implants for reconstruction and revision patients only.

• December 1992: Dow Corning announced that it would no longer make five implant grades of silicone for sale after March 31, 1993, but that it would continue to manufacture 45 other medical grades of silicone materials.

• January 8, 1993: FDA published a 515(b) proposal in the Federal Register calling for safety and effectiveness data for saline-filled breast implants.

• June 2, 1994: FDA sponsored a Part 15 Hearing on saline-filled breast implants to hear testimony from all interested parties concerning the timing of the agency's review of the safety and effectiveness of saline-filled breast implants. FDA promised to make a decision by the end of the year.

• July 15, 1994: FDA granted conditional approval of an IDE pilot study of 50 patients for a breast implant filled with a purified form of soybean oil (TrilucentT implant).

• October 21, 1994: FDA sponsored the workshop Alternatives to Silicone Breast Implants. The workshop provided a forum for FDA to present a draft guidance document for testing requirements for alternative breast implants.

• December 23, 1994: FDA issued a Talk Paper describing the types of studies required to demonstrate the safety and effectiveness of saline-filled breast implants and the date the studies are expected to be completed. Preclinical data were submitted throug