FDA's General & Plastic Surgery Devices Panel concurred with public commenters who urged that women should have access to silicone breast implants by recommending approval for Mentor's premarket approval application April 13.

However, the panel attached significant conditions to its recommendation for approval and opted against approval for Inamed's implants on April 12 in response to opponents' charges that silicone implants lack long-term safety data.

The panel heard from over 150 presenters in an emotional three day meeting, underscoring the controversy surrounding silicone implants.

Panelist Marilyn Leitch, MD, University of Texas Southwestern Medical School, stressed that "choice for victims of breast cancer is critical."

Although augmentation accounts for roughly 80% of the breast implant market, panelists and public commenters alike asserted that the reconstruction patients were more likely to benefit.

Because mastectomy leaves breast cancer survivors without native breast tissue, saline implant side effects may be more apparent, according to public commenter Michelle Lockwood, MD, a fellow in plastic surgery at Georgetown University and breast cancer survivor.

"Due to the thinness of my skin tissue, I was quite concerned that saline implants would produce significant rippling in my reconstructed breast," she said in explaining her decision to receive silicone implants.

Additionally, a comment letter from 18 organizations - including the American College of Surgeons, National Coalition for Cancer Survivorship and Susan G. Komen Breast Cancer Foundation - advocates "the right of each patient to select and receive individualized treatment options."

"External prostheses can be impractical, and saline-filled breast implants often may not achieve acceptable symmetry, appearance or comfort," the letter adds.

Groups such as the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery also urged the panel to consider the non-medical benefits of the implants, including more natural aesthetics and quality-of-life issues.

The Washington Legal Foundation also supported approval based on a legal perspective. The firm claimed on April 11 that FDA cannot deny approval for silicone breast implants, according to federal law.

WLF Chief Counsel Richard Samp maintained that the "basic tenets of administrative law" underscore that the collection of "additional long-term data may be imposed in the postmarket phase only."

In a January 2004 draft guidance, which corresponded with a "not-approvable" letter regarding Inamed's silicone implants, FDA suggests it is seeking about 10 years of follow-up data.

Because both Inamed and Mentor submitted their premarket approval applications to FDA before issuance of the guidance, the two firms are exempt, Samp argued.

Silicone breast implant opponents were equally adamant that the devices remain banned until further safety can be established.

National Organization for Women President Kim Gandy urged against approval in both spoken and written comments. She lamented that FDA is "still without long-term safety data."

"The data provided by Inamed and Mentor continues to be unimpressive - despite years of clinical trials, silicone implant manufacturers simply have not provided regulators with the necessary data," Gandy's written comments state.

She refers to the need for information about the impact of implants on mammography results, citing a five-year study finding much higher rates of undetected breast tumors in women with implants.

Despite their positive vote for Mentor's application, panelists did heed warnings from the public commenters' negative rally cries.

In an extensive list of recommended conditions, panelists voted to include connective tissue disorder sign and symptom analyses and quality-of-life measures in long-term follow-up from the firm's core study. They also asked FDA to stipulate a registry to collect information including pregnancy outcomes, breastfeeding effects and mammography results.

Panel Responds To Public Comments With Silicone Implant Recommendations

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