Fw: Letter to the FDA from your Senator or Congressman

[Guest guest]

Sent: Saturday, October 04, 2003 10:20 AM

Subject: Letter to the FDA from your Senator or Congressman

ALL BREAST IMPLANT WOMEN AND THEIR LAWYERS - PLEASE FAX A COPY OF THIS LETTER REQUESTING THAT YOUR SENATOR OR CONGRESSMAN SIGN THIS AND FAX TO THE FDA PRIOR TO OUR OCT. 14-15 MEETINGS.

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September 29, 2003

The Honorable Mark McClellan, M.D.

Commissioner

Food and Drug Administration

Parklawn Building

5600 Fishers Lane

Rockville, land 20857

Dear Dr. McClellan:

We are writing to express our concern about the upcoming Food and Drug Administration (FDA) review of clinical data on silicone gel-filled breast implants scheduled for October 14 and 15, 2003.

It has come to our attention that at least one manufacturer of silicone gel-filled breast implants has filed clinical data from an investigational device exemption (core) clinical trial based on only a few years of patient follow-up. It is our concern that clinical data based on only a few years of clinical patient follow-up will fail to address the long-term problems that can affect women’s health.

Due to the late onset of local, regional and systemic complications and that potential long-term risks of silicone gel-filled breast implants could vastly outweigh any benefits for the “healthy” patient population, we strongly believe the core clinical trials should be extended to better assess long-term safety prior to approval.

In a recent letter sent to Senator Kennedy (D-MA), the FDA acknowledged that “there are additional safety issues that apply to the silicone implants that do not apply to the saline implants, such as silent rupture and gel migration, which will need to be evaluated.” Research has consistently demonstrated that the onset of the majority of complications related to silicone gel-filled breast implants occur between 7 to 10 years and, unlike saline breast implants, are often not detected by women for many years after they occur. Research conducted at the FDA by S. Lori Brown, Ph.D., verified the latency of developing complications associated with silicone gel-filled breast implants, including rupture and gel migration. [1][1]

The manufacturing community has acknowledged the potential risks associated with silicone breast implants. A United States Patent dated June 26, 2001 filed by McGhan Medical Corporation (now Inamed Corporation) states:

“Adverse medical consequences have recently become associated with the use of silicone gel filled implants because it has been discovered that the silicone oil can migrate through the implant shell and the silicone oil is not biocompatible with other human tissues. Therefore, the use of silicone based filler materials has been discontinued in the industry.”

Despite a decade passing since silicone gel-filled breast implants were restricted on the market, a prevailing concern remains about the long-term safety of these devices, particularly an elevated risk of an immunological response, potentially contributing to the development of systemic illness, following long-term implantation of silicone gel-filled breast implants. Recently published and ongoing research continues to demonstrate the real potential of an immunological response to long-term implantation of silicone gel filled breast implants particularly in the presence of significant rupture or verifiable gel migration. Research at the National Institutes of Environmental Health Sciences and published research by the FDA has demonstrated the presence of immunological responses to silicone gel-filled breast implants including a significant association with fibromyalgia. [2][2]

Given the decades-long availability of silicone gel-filled breast implants despite never having been approved, it is imperative that the FDA complete a thorough assessment of the long-term safety of these devices prior to approval. Recent research suggests that complications often have a delayed onset. The ongoing and loosely monitored adjunct “study” is not a sufficient substitute for long-term safety data collected through rigorous core clinical trials. Therefore, we request that the FDA delay the review of the current trials in order to collect long-term data and fully assess the risks of silicone gel-filled breast implants. It is vital to ensure that the health of future generations of women is not put in jeopardy by a device whose long-term risks far outweigh the long-term benefits.

We also request a meeting with you on or prior to September 30, 2003 to discuss these outstanding issues.

Sincerely,

Gene Green

Member of Congress

GG:sgs

[1][1] Brown SL, MS Middleton, WA Berg, MS Soo, G Pennello. Presence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama. American Journal of Roentgeonology; 175: 1057-1064, 2000.

[2][2] Brown SL, Duggirala HJ, Pennello G. An Association of Silicone-Gel Breast Implant Rupture and Fibromyalgia. Current Rheumatology Reports, 2002; 4:293-298.