FOR IMMEDIATE RELEASE
Contact: Adriana Surfas
Thursday, October 11, 2007
FDA Ignoring Requirement for Post-Market Surveillance of Breast Implants
Less than one year after approval, FDA allows company to change study requirement Washington , D.C. – Congresswoman Rosa L. DeLauro (Conn. – 3), as part of an on-going effort to ensure that science – and not corporate interests – informs decisions within the Food and Drug Administration, sent a letter to Dr. Andrew von Eschenbach, FDA Commissioner, seeking information regarding a change in a mandatory post-market requirement for silicone breast implants.
Earlier this year, Mentor , a manufacturer of silicone breast implants, announced that the FDA approved an amendment to the company's Post Approval Study Protocol that eliminated a mandatory requirement that each patient receiving silicone breast implants be enrolled into a study.
The FDA approval of silicone breast implants last November was based on a number of conditions that the manufacturers were to follow, and those conditions already appear to be changing less than on year after their approval.
"If true, this raises serious policy questions regarding the FDA's post marketing approval process," DeLauro stated. "This also raises serious questions about the FDA's ability and willingness to conduct the new post-market safety measures that were recently enacted in the new Prescription Drug User Fee Act.
If industry will be able to dictate the terms and conditions of the post-market studies required under PDUFA, it will be rendered useless."
In May of this year, Rep. DeLauro introduced The FDA Scientific Fairness for Women Act, which would rescind the approval of silicone breast implants if their safety has not been conclusively demonstrated for the life of the implant.
This bill has been endorsed by the National Research Center for Women and Families, Breast Cancer Fund, National Women's Health Network, NOW, Reproductive Technologies Project, Our Bodies Ourselves, In the Know and Command Trust Network.
Additionally, the legislation would require the FDA to convene a scientific workshop on the use of emergency contraception by young women under the age of 18 and elevate the Office of Women's Health within the FDA so that it reports directly to the Commissioner. Below is the full text of the letter:
October 11, 2007
The Honorable Andrew von Eschenbach, M.D.
Commissioner Food and Drug Administration
5600 Fishers Lane Room 14-71 Rockville, MD 20857
Dear Dr. von Eschenbach:
I am writing to express concern about the potential amendments to Mentor's MemoryGel Breast Implants Post Approval Study (PAS) Protocol. Silicone breast implants were approved based on a number of conditions that Mentor and Allergen were to follow, and less than one year after their approval, the conditions appear to be changing. If true, this raises serious policy questions regarding the FDA's post marketing approval process.
Mentor announced on May 2 that the FDA approved an amendment to the PAS protocol, which removed a mandatory requirement that each patient receiving silicone breast implants be enrolled into a study. The announcement claimed that the amendment was a response to feedback from Institutional Review Boards and physicians who were concerned about the restriction of patient access to silicone breast implants. What specific data was provided to the FDA to justify this request?
Was an advisory board called or asked about the change? In addition, please provide a status report of the post- approval studies for saline breast implants made by Mentor and McGhan (now Allergan). As a condition for approval in 2000, both companies were required to continue their 3-year safety studies for an additional 7 years, so these 10-year studies should be completed this year.
However, when the FDA held a public meeting to discuss the 5-year data in July 2002, Mentor did not have follow-up health data on most of their patients. Since the same companies are also responsible for 10-year post-market studies of silicone gel breast implants, the quality of their 10-year studies of saline breast implants, and the rigor of FDA's monitoring of those studies, is an important indication of whether the FDA will exercise its regulatory authority on the silicone gel breast implant studies or any other required post-market studies. As part of this request, please include information about the number of women initially enrolled in each study, the number of women for whom data regarding health and complications were collected at 3 years, 5 years, 7 years, and 10 years, the results of the studies, and the FDA's assessment of the quality of the studies and the implications for patients.
Please also include all appropriate information pertaining to Mentor's request, such as information about FDA's internal process for considering it, and the current status of post- marketing studies and conditions. All documents (electronic or hard copies), internal memoranda, communications, data, public input, and notes pertinent to this consideration also would be appreciated.
I look forward to your timely response.
Sincerely, ROSA L. DeLAURO
Chairwoman House Appropriations Subcommittee on Agriculture Rural Development, Food and Drug Administration, and Related Agencies