Breast Implant and FDA

If you are considering breast augmentation, the breast implant and FDA relationship is something you should understand.

Breast Implant and FDA

Prior to 1976, the breast implant industry was unregulated. Given the current regulations, this certainly is surprising. Regardless, the government eventually got involved with the Federal Drug Administration being assigned oversight. Here is a timeline of key events in the breast implant and FDA relationship.

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 submissions in which manufacturers present data showing the safety and effectiveness of these devices.
January - March 1989: An unpublished study showed that polyurethane foam, which was used as a coating on certain types of silicone gel-filled breast implants, would degrade and release 2-toluene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. Shortly afterwards, the manufacturer of polyurethane foam-coated breast implants removed them from the market.
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 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).
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.
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).
September 4, 1996: Poly Implants Protheses (PIP)'s 510(k) for their saline-filled breast implants was cleared for marketing by FDA.
May 6, 1998: Mentor Corporation and its subsidiary, Mentor Texas, signed a consent decree of permanent injunction, promising to 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 permitted Mentor Corporation to continue marketing its breast implants because the deficiencies in Mentor Corporation's manufacturing process were not shown to result in a significantly increased risk to women who received this company's breast implants.
June 5, 1998: FDA approved Inamed Corporation's IDE study for silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites.
June 22, 1999: The IOM released a comprehensive report of the published literature and ongoing studies on both saline-filled and silicone gel-filled breast implants entitled Safety of Silicone Breast Implants. The IOM made a clear distinction between local complications and systemic health concerns. The IOM determined that there was insufficient evidence to establish that either or both types of breast implants cause systemic health effects, such as autoimmune disease, and that there were no new health or safety issues associated with the use of both types of implants. The IOM also concluded that local complications are "the primary safety issue with silicone breast implants." These local complications, which include rupture, pain, capsular contracture, disfigurement, and serious infection, may lead to medical interventions and repeat surgeries.
May 10, 2000: FDA granted approval of Mentor Corporation's and Inamed Corporation's saline-filled breast implant PMAs. Both PMAs included data on the types and rates of local complications experienced by patients. Despite complications experienced by some women, the majority of those women still in the Inamed Corporation and Mentor Corporation studies after three years reported being satisfied with their implants.
August 22, 2003: Consent Decree with Mentor Corporation was vacated by court. Mentor satisfied FDA's requirement that Mentor's Irving, Texas facility be in continuous compliance for at least five years with the FDA's current good manufacturing practices requirements.
December 12, 2003: Mentor Corporation submitted a PMA for their silicone gel-filled breast implants.
January 7, 2004: Inamed Corporation announced that they received a "Not Approvable" letter from FDA for their silicone gel-filled breast implant PMA and that the letter outlines the additional information that Inamed Corporation must provide prior to the FDA's further review.

As this timeline shows, the breast implant and FDA relationship has been a long running dance. The FDA demands empirical data on the health ramifications of implants and manufacturers grudgingly supply bits and pieces. This process will eventually play out at some point, but it is difficult to ascertain when.

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