Fw: Platinum Research needed

[Guest guest]

Martha Murdock, DirectorNational Silicone Implant Foundation | Dallas Headquarters"Supporting Survivors of Medical Implant Devices"4416 Willow LaneDallas, TX 75244-7537

----- Original Message ----- From: m keeling

MARTHA ; jcraig@... ; S3733@...

Cc: jameyslacy@... ; toxicdiscovery@... ; rubyrm@... ; Llfladung@... ; JAGUAR4ME@... ; LADT65@...

Sent: Wednesday, March 19, 2003 5:23 PM

Subject: Platinum Research needed

Please post this to your e-mail lists:

March 17, 2003

Senator Kay Hutchison

248 Senate Building

Washington, D. C.. 20510

FAX: 202/224-0776 ATTN: Kalynne Harvey Welsh

Dear Senator Hutchison:

Thank you for your letter dated 2/10/03. While I appreciate your work to increase the budget of the NIH to help discover the causes for diseases, I am at a loss to explain to the women of Texas why your office refused to co-sign Senator Kennedy's enclosed letter to the FDA. We need your leadership to hold the manufacturers of defective medical devices and the FDA accountable for making safe and effective breast implants. If one in eight women can expect to get breast cancer, a lot of women will need accurate information to make an informed decision about the risks versus the benefits of implanted devices.

Recent Dow funded Swedish research (Koot, et al., 2003) confirmed NIH research finding increased rates of lung cancer and suicide among breast-implanted women. The Swedish study makes the absurd conclusion that women who choose breast implants have some sort of "psychopathology" that is responsible for the high suicide rate. I know from networking with women with implants they often suffer from unendurable pain, declining health, depression when the medical establishment turns their back on them after they get sick from "unknown" causes, guilt when they suspect their child's health has been effected, loss of insurance, lack of funds to get their ruptured implants removed, and a feeling of not wanting to be a burden to their families.

Recent German independent research (Flassbeck, et al., 2003) found that siloxanes (D4, D5, D6) and platinum leak from prostheses and accumulate in surrounding tissue including breast, muscle, and fat tissue, while no siloxanes were detected in control tissue. Platinum is suspected to be an immunotoxicant, a neurotoxicant, and an organ toxicant. Dow notified the EPA on 12/27/96 of substantial risk to 3-8015 intermediate platinum #2 (used as a catalyst in making the gel and shell of implants). We need independent NIH research to determine if siloxane and platinum accumulation in combination with smoking, may account for the increase of lung cancer, brain cancer and other cancers in breast-implanted women.

Just like women needed independent research to assess the risk versus the benefits of hormone replacement therapy, women deserve to know the risks versus the benefits of implanted medical devices. I hope we can count on your support of this important issue.

Sincerely,

Keeling

12615 Misty Valley

Houston, Tx. 77066

Senator Kennedy's letter follows:

Mark McClellan, M.D., Ph.D

Commissioner

U.S. Food and Drug Administration 5600 Fishers Lane

Rockville, MD 20857

Dear Dr. McClellan:

We are writing about the FDA's oversight of breast implants. Specifically, we have several questions about FDA's approval of saline breast implants, FDA's upcoming review of applications for approval of silicone breast implants, and significant gaps in our knowledge about the safety of these products.

(1) FDA approved Mentor Corporation's premarket approval application for saline breast implants in May 2000. We understand that, at the time, FDA was conducting a criminal investigation that implicated Mentor's conduct of clinical trials that produced the data for that approval. Why didn't FDA invoke its Application Integrity Policy, both to delay approval of Mentor's premarket approval application and to require clinical data about which there were no questions of integrity or reliability? Although no criminal charges arose out of this investigation, has FDA nonetheless found evidence to question the integrity or reliability of clinical data used to approve Mentor's saline breast implants?

(2) We understand that, when approving the saline breast implants, FDA considered there to be no alternative device available to meet the public health need of treating, for example breast cancer survivors seeking reconstructive surgery. Considering the needs of breast cancer survivors seeking reconstructive surgery, will silicone breast implants need to show a higher level of safety and effectiveness than if saline breast implants were not available?

(3) We understand that breast implant manufacturers have used incorrect identifiers (identifiers assigned to other device manufacturers) when reporting adverse events for their breast implants under the agency's medical device reporting system. Has FDA investigated these violations? If not, why not? If so, what did it find? How have losses of adverse event data caused by use of incorrect identifiers affected FDA's ability to monitor and assess the safety of saline breast implants and review the safety of silicone breast implants?

(4) We understand that the agency has permitted alternative summary reporting for breast implant adverse events when these products have been under clinical investigation or before at least 2 years after approval, contrary to stated agency policy. Why did the agency permit such summary reporting in these situations? Why is such summary reporting appropriate for an implanted device, whose long term use raises issues about safety and effectiveness that cannot be answered, and may not even come to light, within 2 years of approval? How does the consequent loss of adequate adverse event data affect FDA's ability to assess the safety of saline breast implants post-approval and, in the context of approving silicone breast implants, their safety?

(5) We understand that breast implants under investigational device exemptions are routinely promoted in advertisements that, although they may comply narrowly with requirements for advertisements to seek clinical subjects, suggest to patients that they will be receiving an approved product, not an investigational product to be studied in a clinical trial. Have these promotional activities in effect lead to the inappropriate distribution of investigational medical devices? How has FDA responded? How will these activities affect FDA's review or approval of applications seeking to market these devices?

(6) Significant loss to follow up in clinical trials for a device can leave gaps in the data about the safety and effectiveness of the product. We understand loss to follow-up to be a problem not only for breast implants but also for temporomandibular joint implants. Indeed, the gaps in the data due to loss to follow-up raised concerns among members of FDA's advisory committees reviewing these products. Despite these concerns, FDA has approved these products. Some have charged that these data gaps amount to lack of a showing of reasonable assurance of safety and effectiveness. How does FDA respond to these charges?

Please provide responses to these questions, with supporting documentation where appropriate, by April 4, 2003. If you have any questions about this request, please contact Dorsey of Senator Kennedy's staff at 202/224-6064.

Thank you for your timely response to this request.

Sincerely,

Senator M. Kennedy

Senator Jeff Bingaman

Senator Hillary Rodham Clinton

Senator Barbara Boxer

Senator L. Landrieu