Despite Unanswered Safety Questions, U.S. FDA Lifts Restrictions On Silicone Breast Implants

The U.S. Food and Drug Administration today announced that it would lift restrictions on the sale of silicone gel breast implants. The agency approved applications by two companies — Inamed (now part of Allergan) and Mentor. The agency also took the unusual step of imposing nearly a dozen conditions on the sale of the devices — including requiring each company to study the safety and effectiveness of the implants in 40,000 women for ten years. The implants are approved for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older. The approval comes just after a former Mentor scientist announced that important research results had been withheld from the FDA (Washington Post, October 13, 2006).

Virtually all silicone breast implants disintegrate in the body over time, according to independent studies. The largest ever analysis of explantation showed that approximately half of silicone implants fail within 10 years and that three-quarters will rupture within 20 [1]. When a silicone implant ruptures, silicone gel can migrate away from the breast area [2]. The manufacturer’s own data revealed that over half of cancer survivors and one in five cosmetic patients require additional surgery within three years of receiving breast implants [3].

“The FDA has decided to approve now and collect safety data later,” said Sybil Niden Goldrich, a long-time women’s health advocate on breast implant issues. “It is simply unacceptable to lift restrictions on the sale of these devices when there are so many known problems and so many unanswered questions.”

“No medical device should be granted final approval if data that reveal potential dangers have not been fully investigated and analyzed. The health and safety of American women should be the top concern of your agency as the approval process moves forward,” said Senators Dianne Feinstein (D-CA) and Olympia Snowe (R-ME) in an October 20th letter to Acting FDA Commissioner Andrew von Eschenbach.

An advisory panel issued a split decision in April of 2005, recommending the denial of Inamed’s pre-market approval application and the approval of Mentor’s. During the advisory panel hearing, FDA scientists expressed concern about high rupture rates, the lack of scientifically valid short-term safety data and the lack of any meaningful long-term safety data presented by either company. Several clinical trial participants testified that they had been unable to report their health problems to the companies.

“I’m very concerned that the patients that develop signs and symptoms are ignored. I propose that data be reviewed again in five years by our panel,” said panel member Dr. Amy Newberger during the April 2005 hearings. Another panel member, Dr. Stephen Li, said, “This device has a 30-year history that is checkered and we need a higher standard for this device [4].”

“These unenforceable post-market approval conditions cannot protect women from a defective product,” said Goldrich. “This decision clearly shows that the FDA is broken and unable to protect Americans.”

Last year the FDA released an internal report that concluded more than half of medical device manufacturers were not performing post-market safety studies required on over half of the products approved between 1998 and 2000 (The New York Times, April 1, 2005).

Background on the Regulatory History of Silicone Breast Implants

The sale of silicone gel breast implants was restricted in 1992 to women who needed them for medical reasons — for augmentation after cancer surgery, for example, or to replace a broken implant. The devices have been available for augmentation since the late 1990s in clinical trials. In 2005, almost 300,000 women got cosmetic breast implant surgery. The majority received saline implants, an implant filled with a saltwater solution. This number has risen significantly in recent years — more than tripling since 1997.

Background on Sybil Niden Goldrich

Sybil Goldrich was one of the first women to speak out publicly about problems with silicone gel breast implants when she published her story in Ms Magazine in 1988. Her appearance on CBS’s “Eye to Eye with Connie Chung” and subsequent activism led to restrictions on the sale of the devices in 1992. Goldrich had four separate sets of implants after mastectomy. Later surgery found silicone in her liver, uterus and ovaries.

[1] Marotta et al. Silicone gel breast implant failure and frequency of additional surgeries: analysis of 35 studies reporting examination of more than 8000 explants. Journal of Biomedical Materials Research, 1999; 48(3): 354-64.

[2] Garrido. Migration and chemical modification of silicone in women with breast prostheses. Magnetic Resonance in Medicine, 1994; 31: 328-30; Katzin et al. Pathology of lymph nodes from patients with breast implants: a histologic and spectroscopic evaluation. Laboratory Investigation, 2002; 82(1): 246A.

[3] FDA Summary Panel Memorandum, Mentor PMA Review Team, March 2, 2005; and FDA Summary Panel Memorandum, Inamed PMA Review Team, March 2, 2005.

[4] See transcript at http://www.fda.gov/cdrh for 66th Meeting, Wednesday, April 13, 2005, U.S. Food and Drug Administration, Center for Devices and Radiological Health, Medical Devices Advisory Committee, General and Plastic Surgery Devices Panel.

Leave a Reply