Implants and the FDA

The FDA (Food and Drug Administration) was given the legal authority to police the production and use of breast implants back in 1976. Although it is the main regulating body when it comes to breast implants, the FDA itself is not composed of scientists who conduct their own investigations on the various medical products that they are looking after. Often, the FDA relies on the research findings of other bodies or creates a panel of experts to examine existing data and generate judgments about whether a product is safe for public use or not.

The FDA placed breast implants under classification III in 1982, which meant that it was under the category for products which are to be evaluated for safety and effectiveness. However, subsequent lapses in documenting the effects of the implants, along with other medical devices already on the market at that time led to questions about the safety of the implants, particularly after women began to emerge with complaints concerning their breast implants.

In 1992, complaints about the safety of silicone implants led the FDA to impose restrictions on the implants. The FDA also came out with guidelines and recommendations for breast implant manufacturers. However, these guidelines are not legal requirements and the company is not obligated to follow the recommendations. The most recent version of the guidance document produced by the FDA titled "Saline, Silicone Gel, and Alternative Breast Implants" came out in November 2006.

Today, four types of implants have been approved by the FDA. Mentor and Allergan, breast implant manufacturers, received their approval from the FDA on 2000 to produce saline-filled breast implants. These implants were approved for use in women 18 years or older for reconstructive purposes. The FDA's decision to approve the products of both companies for public use came after a thorough review of the companies' CORE studies, laboratory testing data, inspections of the manufacturing facilities of each company, and after thorough deliberations of the 2003 and 2005 Advisory Panels.

Approval for silicone-filled implants came in 2006 for both companies, under the provision that the implants be used in women 22 years or older and for reconstructive purposes in women of any age.