Plastic Surgery Societies Applaud FDA Panel Recommendation That Mentor's Silicone Breast Implants Be Approved With Conditions

FDA’s General & Plastic Surgery Devices Panel voted against approval for Inamed’s silicone gel-filled breast implants, citing insufficient long-term data.

The panel decided 5-4 against recommending approval at the April 12 meeting, following a day of emotional public comment on April 11.

FDA presenters were critical of Inamed’s two data sets of magnetic resonance imaging-detected implant rupture taken at one and three years from its Core study. Using the two data sets, FDA presenters showed rupture rates were unpredictable by providing alternate models.

Although Inamed assumed that rupture rates would remain constant over a 10-year period for a 14% rate, FDA further argued that the rupture rate also could increase in a linear or quadratic manner over the 10-year period, yielding a significantly higher rupture rate.

Panelist Amy Newburger, MD, Dermatology Consultants of Westchester, stressed that her vote against approval “in no way denigrates the data collection.” However, she said “it was premature,” suggesting that another 18 months of data would answer FDA’s questions about rupture rates.

Fellow panelist Joseph LoCicero, MD, University of South Alabama, concurred, saying that the data, despite being “magnificently manipulated, [were] only two real data points.”

Inamed may have been hurt by FDA’s decision to prevent plastic surgeon Michael Olding, MD, George Washington University School of Medicine, from voting due to conflict-of-interest concerns. Although the agency offered him the opportunity to partake in panel discussions, Olding opted against participating, according to the agency.

The meeting marked Inamed’s second appearance before the General & Plastic Surgery Devices panel to seek approval for silicone breast implants for augmentation, reconstruction and revision indications.

The Santa Barbara, Calif. company received a positive recommendation for approval from the panel in December 2003, but FDA ultimately issued a non-approvable letter, citing insufficient safety data.

Since presenting study results at the 2003 meeting, the firm acquired an additional year of data, with all patients being followed for at least three years. Inamed also has completed MRI data for detecting silent rupture for augmentation patients at one and three years, and one-year and partial three-year data for reconstruction and revision patients.

The premarket approval application is based primarily on the firm’s core study, which enrolled a total of 940 patients (500 augmentation, 220 reconstruction and 220 revision patients), and planned to follow patients for 10 years. Approximately one-third of augmentation, reconstruction and revision patients were scheduled to receive an MRI at the one, three, five, seven and nine years following implantation.

Total rupture rates for the MRI cohort at four years were 3.4% for augmentation, 20.5% for reconstruction and 10.9% for revision. In comparison, total rupture rates in the non-MRI cohort through four years dropped to 1.1% for augmentation, 4.9% for reconstruction and 1.7% for revision.

In addition, panelists expressed dissatisfaction with the firm’s postmarket approval plans. Roughly half of the panelists thought that Inamed should collect data on children of women who have implants – a policy the firm had opted against in its proposal.

Panelists also were critical of Inamed’s proposal to discontinue its quality-of-life questionnaire at the six, eight and 10-year marks. Although Inamed insisted the questionnaire offered limited value, panelists believed it could provide information as long as natural aging is taken into account.

In addition, panelists were skeptical of Inamed’s plan to tap the Danish Registry to collect data addressing outstanding concerns, since the firm’s devices only comprise one-quarter of the implants in the registry.

http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Stories/0411-1205_SiliconeR1.htm