Mentor's Memory Gel silicone breast implant moved one step closer to earning FDA approval July 28 with the receipt of an "approvable letter" listing conditions the company must meet to bring the device to market.

According to Mentor, the requirements are "generally consistent" with the conditions of approval recommended by FDA's General Plastic Surgery Devices Panel at its April 13 meeting.

"As is typical of FDA approvable processes, Mentor intends to engage in confidential discussions with the FDA to address these conditions, prior to the FDA's final decision on approval," the company explains in a July 28 release.

Memory Gel could become the first silicone breast implant on the U.S. market since 1992.

The panel voted 7-2 in favor of recommending that the device be approved with conditions, including requirements that physicians be Board Certified and Eligible Plastic Surgeons and trained with the Memory Gel before receiving devices to implant (¹ Also see "Panel Responds To Public Comments With Silicone Implant Recommendations" - Medtech Insight, 18 April, 2005., p. 7).

The panel also advised FDA to have Mentor to follow their "core" clinical trial patients for at least 10 years. The company presented three-year data on 420 patients from the core study with one and two-year MRI follow-up. Roughly 1% of the devices in the study ruptured within three years of implantation.

The advisory committee voted in favor of holding a meeting to review 5-year follow-up data.

It also recommended that Mentor establish an independent data safety monitoring committee to review the data and attempt to obtain follow-up information on patients who have had their implants removed and not replaced.

The panel voted in favor of Mentor's device the day after recommending against approval of Inamed's application, citing the 8.3% rupture rate of the Style 153 implant at three years.

Following discussions with the agency, Inamed has dropped the Style 153 from the PMA. The firm also plans to supplement its PMA application with data on its Style 410 Cohesive implant, which Inamed expects the panel to review this summer (² Also see "Inamed’s Amended Silicone Breast Implant PMA Sheds Style 153 Model" - Medtech Insight, 25 July, 2005., p. 20).

In a release commenting on Mentor's approvable letter, Inamed says it "remains confident about its recently modified responsive silicone gel implant PMA, currently under FDA review, which is comparable to the competitor's in terms of safety and effectiveness."

The April meeting was extremely contentious with over 150 members of the public commenting over three days.

Following the panel, several women's health advocacy groups asked Congress to investigate the committee's deliberation and conclusions, claiming that FDA gave conflict-of-interest waivers to panelists who were biased in favor of approving the device.

President of the National Research Center for Women & Families called the approvable letter "a stumbling step in the wrong direction, amid mounting questions about FDA decision-making."

"We hope that [new FDA Commissioner Lester] Crawford's first act as commissioner will not be one of 'sales before safety.'" Command Trust Network Executive Director Sybil Goldrich said in a July 28 release. "He should not turn his back on eighteen years of appropriate caution on silicone breast implants by stamping 'guinea pig' on the foreheads of hundreds of thousands of women."

The National Women's Health Network also voiced alarm. "We are very concerned that the FDA has once again put industry interests ahead of women's health," the network argues in a same-day statement, reiterating its opposition to Memory Gel's approval.

NWHN argues that Mentor has yet to address three major deficiencies in their application. According to the Washington, D.C. advocacy group, Mentor's two-year rupture data does not adequately characterize the device's long-term risk.

Also, the group says that "it appears that Mentor skewed its data by dropping women from its study if they had problems with their implants" and notes that four of the six models of implants covered by the application were not actually used in the study.

The American College of Surgeons, National Coalition for Cancer Survivorship, Susan G. Komen Breast Cancer Foundation, the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery support Memory Gel's approval.

Mentor Earns FDA “Approvable Letter” For Silicone Breast Implant

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