FDA

Ban on implants

Until two days before he called for a temporary halt to the use of silicone gel breast implants, Food and Drug Administration Commissioner David A. Kessler was planning to allow certain exceptions, including breast cancer patients seeking reconstruction after mastectomies, according to knowledgeable sources.

But he changed his mind after reviewing hundreds of internal documents from Dow Corning Wright, the leading manufacturer of the controversial devices, the sources said.

"He was headed toward some limited availability" for several different categories of women, sources said. These would have included--in addition to breast cancer patients--women seeking a replacement for a ruptured implant, burn and trauma patients and those suffering from congenital abnormalities, such as the absence of a breast, sources said.But the FDA chief experienced real concern after "seeing the whole picture" portrayed in the memos. >>

FDA hearings

Radio-interview with implants researcher/scientist in chemistry Dr. Blais. Listen here: >>

Diana Zuckerman, director of National Research Center for Women & Families. / Breastimplantinfo.org >>

Dr. Edward Melmed. plastic surgeon >>

Kim Gandy. President National Organization for Women.>>

225 articles and testimonies about this in the archives of breastimplantinfo.org >>

Conflict of interests

2003 Michael Miller, a voting member of the FDA panel and the plastic surgeon, said to be a consultant for Inamed.

The concluding words in a letter about possible conflicts of interest between silicone implants Advisory Committee Member and Inamed Aesthetics: " It is very likely that other members of the advisory committee had been given a different perspective on the enthusiasm

of Dr. Miller regarding the safety of breast implants, if they had been aware of this conflict of interest..

This must surely have had an effect on the consideration of the FDA's advisory committee on the voting which was so strongly influenced by the support of Dr. Miller's approval. >>

Remarkable

This will be Inamed's second appearance before the FDA's plastic surgery devices advisory committee since October 2003, when members voted 9-6 that the company should be allowed to sell silicone-gel implants to anyone who wants them.

In a letter the next month, however, non-voting panel chair Thomas Whalen, a pediatric surgeon at the Robert Wood Johnson Medical School in New Jersey, asked the FDA to ignore the committee's "misguided" vote because Inamed had not conducted rigorous long-term safety studies.

The FDA appeared to take Whalen's letter seriously. In January 2004, the agency rejected the advisory panel's advice, a rare step, and issued Inamed a "non-approvable" letter. A few days later, the FDA released a revised "guidance" detailing what information manufacturers must provide to resume marketing silicone-gel implants. >>

Two former employees of a major manufacturer of silicone breast implants said in sworn depositions in 2003 that the company for years made defective implants that were prone to rupture and hid this information from customers and federal regulators.

One employee, J.C.K, who from 1996 until 1998 was manager of product evaluation for the company, the Mentor Corporation, said some top executives instructed him to destroy reports detailing the high rupture rates and poor quality of some types of implants because the products "are in the customers." 2005 >>

Physicians who are advising the FDA, are no longer allowed to receive large payments ($50,000 threshold) from pharmaceutical industry 2007 >>

Approved?

FDA Approves Silicone Gel-Filled Breast Implants After In-Depth Evaluation. Agency Requiring 10 Years of Patient Follow-Up >>

However:

Three years into the studies, Mentor, the maker of Memory Gel implants, has lost 79% of the patients they enrolled, while Allergan, the maker of Natrelle implants, has lost nearly 40% of their study participants two years after enrollment.

As a result, experts said the studies had already lost the power to detect the rare events they were designed to look for. >>

Reactions on approval

American organizations for women shocked about approval silicone breast implants (2 movies) >> and >>

Reaction from Breast Cancer Action >>

Reaction dr. Pierre Blais and Robert Guidoin: They are still unsafe >>

News on breast implants American websites

1. Breastimplant. org >>

2. NOW's work on breast implants >>

3. National Women's Health Network >>

4. Public Citizen >>

5. Testimonies >>

6. Humantics Foundation (no longer updated) >>

7. Our bodies Ourselves >>

8. The movie: Absolutely Safe>>

As a condition of approval for the Natrelle 410 breast implants, Allergan must:

  • Continue to follow, for an additional five years, approximately 3,500 women who received the Natrelle 410 implants as part of the company’s continued access study;
  • Conduct a 10-year study of more than 2,000 women receiving Natrelle 410 silicone gel-filled implants post-approval to collect information on long-term local complications (e.g., capsular contracture, reoperation, removal of implant, implant rupture) and less common potential disease outcomes (e.g., rheumatoid arthritis, breast and lung cancer, reproductive complications);
  • Conduct five case control studies to evaluate the possible association between the Natrelle 410 implants, as well as other silicone gel-filled breast implants, and five rare diseases—rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma;
  • Evaluate women’s perceptions of the patient labeling; and
  • Analyze the Natrelle 410 implants that are removed from patients and returned to the manufacturer.

FDA approves new silicone breast implants. 2013 >>

FDA approves silicone gel breast implants without public meeting 2013 >>

Statement of dr. Diana Zuckerman on FDA approval of new silicone breast implant Natrelle 410 >>

Summary of safety and effectiveness data 2013 >>

Regulatory History of Breast Implants in the U.S. 1976-2013 >>

The FDA's deadly gamble with the safety of medical devices 2012 >>

FDA Update on the Safety of Silicone Gel-Filled Breast Implants 2011 >> This research was financed by Inamed and Mentor

Testimony of Pamela Bridgewater on behalf of our bodies ourselves 2011 >>

FDA Panel Calls for Silicone Breast Implant Registry 2011 >>

Summary of safety and effectiviness data 2005 >>

Guidance for Industry and FDA Staff - Saline, Silicone Gel, and Alternative Breast Implants 2004 >>

FDA Breast Implant Consumer Handbook - 2004 Edition (about toxic chemicals) 2003 >>

Adjunct study protocol Mentor silicone breast implants 1993 >>

More news: the FDA and implants >>

The Basis of the FDA's Decision on Breast Implants 1992 >>