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Regulatory History

Overview

Due to loopholes in federal law, the U.S. Food and Drug Administration (FDA) has never conducted a proper safety assessment of silicone gel breast implants. When Congress first gave the FDA authority to regulate medical devices in 1976, silicone implants had already been on the market for many years. They were "grandfathered in" by the law and allowed to remain on the market even though the data submitted by the manufacturers was either deemed insufficient by the FDA or withdrawn by the manufacturers.

In the early 1990s, growing evidence of problems related to silicone implants prompted the FDA to require manufacturers to submit data on safety and effectiveness. The agency said that silicone implants could be used for augmentation only as part of approved clinical trials. In November 2006, manufacturers gained FDA approval to widely offer silicone implants to women once again.

Saline implants were approved in 2000, despite serious concerns about manufacturers' safety data and considerable evidence that implants routinely cause complications. In the press release announcing the approval, David Feigal, M.D., then-director of the FDA's Center for Devices and Radiological Health, stated that "it's clear from these studies that there is a possibility that a substantial number of women who get these implants will require additional surgery at some point to remove or replace their implants because of complications."

FDA Timeline – Breast Implants

2006 The FDA lifts a 14-year ban on silicone breast implants. Its approval of silicone breast implants manufactured by Allergen and Mentor includes no requirements for safety assurances.

2006 The FDA announces they would conduct a study of 80,000 women over 10 years to see if the devices are safe.

2003 Commenting on the safety of breast implants, Dr. David Feigal, head of the FDA's Center for Devices and Radiological Health, remarks to the Los Angeles Times that people have the misconception that an FDA-approved product is safe. Rather, he says, the agency evaluates products to see if risks outweigh benefits and then it's up to "the consumer to decide whether or not they're willing to take those risks."

2000 The FDA approves saline-filled breast implants, despite concerns noted during the review process. In an agency press release announcing the approval, David Feigal, director of the FDA's Center for Devices and Radiological Health, states that "it's clear from these studies that there is a possibility that a substantial number of women who get these implants will require additional surgery at some point to remove or replace their implants because of complications."

1998 The FDA opens a criminal investigation of Mentor Corporation. The investigation is never properly and thoroughly pursued, according to company informants and former FDA employees.

1992 The FDA restricts sales of silicone breast implants because of the absence of good safety data. The greatest concern was growing evidence that breast implants do not "last a lifetime," as had been claimed, and would eventually rupture, leaking silicone that could migrate to other parts of the body, including vital organs.

1990 The House of Representatives holds oversight hearings, chaired by Rep. Ted Weiss (D-NY), on the FDA's regulation of breast implants. The hearings focus on safety information and the potential risks of polyurethane-covered silicone implants. The FDA is criticized in the hearing and subsequent report (published in January 1993) for not requiring breast implant manufacturers to prove that their products are safe.

1988 Reported problems lead the FDA to propose that all breast implants, both saline and silicone, be placed in Class III, which requires manufacturers to produce data demonstrating their safety and effectiveness.

1976 Congress passes the Medical Device Amendments to the Food, Drug, and Cosmetic Act, for the first time giving the FDA responsibility for regulating all medical devices. Since breast implants were already being sold in the U.S., they are "grandfathered in" and allowed to stay on the market despite the fact that manufacturers had submitted no data or proof to the FDA establishing their safety.

Current Research

The following selective bibliography is for anyone desiring more details on the scientific evidence detailing the risks of breast implants. Links to reports and abstracts are provided where available.

© 2007. Command Trust Network