Inamed expects its modified silicone breast implant premarket approval application to receive FDA approval by the end of the summer.

After consulting with the agency, the company has removed the Style 153 shaped implants from its application and will no longer offer the model in U.S. clinical studies.

The decision to alter the application follows a negative review by FDA's General & Plastic Surgery Devices Panel in April. Panelists voted 5-4 to recommend against approval, citing concern with high rupture rates associated with the double-lumen Style 153 implants (¹ Also see "Inamed To Carry On Quest For Silicone Implant Approval After Panel Rejection" - Medtech Insight, 18 April, 2005., p. 4).

In a July 15 letter to clinicians and physicians disclosed in the firm's 8-K filing with the Securities & Exchange Commission, Inamed says it believes "the action...is appropriate based on the Core study interim data."

The data, which included 1,782 implants at three years follow-up, revealed an 8.3% rupture rate for the Style 153 implants. In contrast, the three-year rupture rate for the other implants was 0.9%.

To further buttress its application, Inamed has added 10-12 years of European rupture prevalence data, according to a July 18 press release.

Mentor, which received a favorable vote (7-2) for its Memory Gel silicone gel-filled breast by the same FDA panel, also expects FDA to rule on its application this summer.

In addition, Inamed anticipates that an FDA panel will be convened to review its next-generation Style 410 Cohesive implants. The company plans to supplement its premarket approval application with three-year follow-up data from the Style 410 Core study and five-to-nine-year European rupture prevalence data.

Inamed submitted a PMA for the cohesive gel implants in December 2004; FDA requested further information in April (² Also see "Inamed Plans FDA Dealings: Panel First, Data Request For Style 410 Second" - Medtech Insight, 11 April, 2005., p. 4).

The Style 410 implants - touted as being thicker and more durable than current silicone implants - are marketed outside of the United States under the brand name BioDimensional Cohesive Gel Matrix .

Inamed’s Amended Silicone Breast Implant PMA Sheds Style 153 Model

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