Fwd: Comments of Sybil Goldrich, Executive Director of the Command Trust Network on the FDA's 'Approvable Letter' to Mentor on Silicone Gel Breast Implants

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Bravo Sybil ...

Comments of Sybil Goldrich, Executive Director of the Command Trust Network on the FDA's 'Approvable Letter' to Mentor on Silicone Gel Breast ImplantsThursday July 28, 7:33 pm ET

WASHINGTON, July 28 /PRNewswire/ -- The following is being released by the Command Trust Network:

STATEMENT: "The battle is not over on silicone breast implants -- FDA can still do the right thing. We hope that Crawford's first act as commissioner will not be one of 'sales before safety.' He should not stamp 'guinea pig' on the foreheads of hundreds of thousands of women.

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As FDA staff scientists have said repeatedly, the safety data are insufficient to show safety -- at best. At worst, the research has been manipulated.

The absurd number of post-market approval conditions recommended at panel cannot protect women from a defective product, especially since the agency itself has made clear it is unable to enforce these conditions.

If the FDA chooses to lift restrictions, Crawford will completely reverse the standards for safety and data on breast implants of nearly twenty years. Eighteen months ago, then-FDA Commissioner Mark McClellan established a clear set of guidelines and required the companies to meet them if they wanted FDA approval. Today, Dr. Crawford has proposed lowering this standard. If the devices are ultimately approved, Crawford will have abandoned any rational basis for FDA's decision making and further underscored the necessity of radical reform at the agency."

SYBIL'S BIO: Sybil Goldrich was the first woman to speak out about problems with silicone gel breast implant when she published her story in Ms. Magazine in 1988. Her 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.

BACKGROUND: The U.S. Food and Drug Administration (FDA) today issued an "approvable letter" to Mentor Corporation for their application for silicone gel-filled breast implants that outlines a number of conditions which the company must meet for full approval of the devices. While this does not mean that Mentor may now market the devices without restriction, it is one of several intermediate steps in the FDA review process of new products. Inamed, another implant manufacturer that is seeking approval for its silicone breast implant, has not yet received indication of approval.

The letter comes after an advisory panel issued a split decision in April of this year, recommending Inamed's application be denied and Mentor's be approved. During the panel, FDA scientists expressed grave concerns over the short-term data and lack of meaningful long-term data presented by both companies. Several clinical trial participants testified that they had been unable to report their health problems to the companies. In May, The New York Times reported that former Mentor employees swore under oath that they had been required to suppress information about breast implant problems.

The unusual number of post-approval conditions reflected the panel's discomfort with the safety data on the devices. In addition to a patient registry and required doctor training, the majority of conditions focused on improving and continuing the research for 10 years. They also required an independent annual data review and reconvening of the FDA panel in five years to analyze the data. However, an FDA report released this March showed that the agency has no power to enforce post-approval conditions and that the majority of companies fail to meet them.

Virtually all breast implants fall apart 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). The manufacturers' own data revealed that over half of cancer survivors and one in five cosmetic patients require additional surgery within 3 years of receiving breast implants(2). In addition, a study conducted by the National Cancer Institute found that women with silicone implants had leukemia and cervical and brain cancers at twice the rate of women without implants(3).

Last year more than 330,000 women got cosmetic breast implant surgery and about 35,000 women had reconstruction after mastectomy. This number has more than tripled since 1997.

The sale of silicone gel breast implants was restricted in 1992 to women who needed them for medical reasons -- for augmentation after mastectomy, for example, or to replace a broken implant. The devices have been available for augmentation since the late 1990s in clinical trials. Saline breast implants -- a silicone shell filled with saltwater solution -- are widely available.

(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) FDA Summary Panel Memorandum, Mentor PMA Review Team, March 2, 2005;

and FDA Summary Panel Memorandum, Inamed PMA Review Team, March 2,

2005.

(3) Brinton et al. Cancer risk at sites other than the breast following

augmentation mammoplasty. ls of Epidemiology, 2001; 11: 248-56.

Source: Command Trust Network