Subscribe to RSSAbsolutely Safe: FDA Regulation
FDA Mission Statement
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
“It’s not that they are free of risk, nothing is free of risk. There are no products that
we regulate that are absolutely without risk, and absolutely with 100 percent benefit.
It’s just not the nature of things we deal with. We’re dealing with medical equipment.
We’re dealing with implants. Nothing lasts forever. Nothing is perfectly safe. And nothing
is absolutely adequate for everyone.”
–Dr. Susan Alpert, Former Director FDA’s Office of Device Evaluation
What does the FDA say about breast implants? Visit the FDA website on Breast Implants
Key Dates
May 28, 1976 -
- FDA gains regulatory authority over breast implants.Breast implants are already on the market.
January 6, 1992 -
- FDA calls for voluntary moratorium (delay) on the use of silicone gel implants until new safety information can be reviewed by advisory panel.
April 16, 1992 -
- FDA lifts voluntary moratorium and places restrictions on silicone gel-filled implants. Calls for more safety studies.
June 22, 1999 -
- The IOM (Institute of Medicine) issues a report stating that there is insufficient evidence to establish that silicone gel and saline breast implants cause “systemic health effects.”
May 10, 2000 -
- FDA approves Mentor and Inamed Corporations saline-filled implants based on three-year studies.
October 2003 -
- FDA advisory panel reviews safety data on Mentor and Inamed’s silicone breast implants. The advisory panel recommends approval; the FDA declines approval.
April 2005 -
- FDA advisory panel reviews safety data on Mentor and Inamed’s silicone breast implants.
November 2006 -
- FDA approves Allergan(formerly Inamed) and Mentor’s silicone implants. Recommends regular MRIs to detect rupture. Calls for continued studies by manufacturers.
Silicone breast implants were on the market for over forty years without formal FDA approval.
When the FDA gained regulatory authority of breast implants in 1976, silicone gel implants had already been sold by Dow Corning Corporation since 1962, and used by thousands of women. Since implants were already on the market, the FDA “grandfathered” them in; the FDA allowed implants to be sold without going through the normal FDA regulatory process and earning formal FDA approval. In essence, the FDA allowed breast implants to be sold without requiring manufacturers to provide data proving implants as safe and effective.
By the early 1990s, thousands of women with similar symptoms, such as fatigue, lupus, joint-pain, and hair loss, believed they were sick from their breast implants. Many women believed that what they were putting in their chest had been FDA approved. However, implants had slipped through a regulatory crack and were neither FDA approved nor vigorously monitored.
In 1992, after public outcry and controversy, the FDA called for a voluntary moratorium (delay) on the sale and use of silicone implants until a panel of experts reviewed existing safety data. After this formal review, the FDA lifted the voluntary moratorium and placed restrictions on the sale of silicone implants. FDA restrictions allowed for silicone implant use by all reconstruction patients and only augmentation patients who chose to take part of in clinical trials. Sixteen years after gaining regulatory authority over breast implants, the FDA had still not granted formal approval to silicone breast implants.
Even with FDA restrictions and without FDA approval, breast implants were profitable products. Over the next six years, manufacturers continued to apply for FDA approval of both silicone and saline implants. In 2000, the FDA approved Mentor and Inamed Corporation’s (now Allergan) saline breast implants, which were often marketed as an alternative to controversial silicone implants. Saline implants were approved based on short-term safety research.
For approval of medical devices such as breast implants, the FDA turns to panels of independent experts on the Medical Devices Advisory Committee to review safety data and make recommendations regarding FDA approval. In 2003, the FDA advisory panel on breast implants held hearings to review safety data submitted by Inamed Corporation on the company’s silicone implants. During this hearing, FDA panelist Nancy Dubler was shocked that the manufacturers presented safety data with only short-term research:
“It’s rare that something shocks me. But I sat on the panel in ’92 and that was
11 years ago. How we could have come from 11 years ago, where we were going
to collect data, to a point where we have a year’s data simply boggles the mind.”
Despite the reservations of several FDA advisors at the 2003 safety hearing, the FDA advisory panel rendered a surprising vote and recommended that the FDA approve Inamed’s silicone breast implants, However, the FDA declined approval of Inamed’s silicone breast implants.
Over the next few years, manufacturers continued efforts to gain FDA approval. Once again, in 2005, the FDA advisory panel held safety hearings. This time it was for two companies’ breast implants—Inamed (now Allergan) and Mentor Corporation. At the conclusion of the 2005 panel hearing, the advisory panel recommended approval for Mentor’s silicone implants, but not for Inamed’s silicone implants. However, in November 2006, the FDA rejected its advisory panel’s recommendation and approved both Inamed (now Allergan) and Mentor’s implants.
Today, under FDA guidelines, any woman may have Allergan (formerly Inamed) and Mentor silicone implants for reconstruction, and any woman 22 or older may have silicone implants for augmentation. The FDA does advise, however, that implant patients have regular MRIs to detect rupture. The FDA also called on manufacturers to conduct post-approval studies.