12.15.06
Silicone Implant History - INAMED Provides Update on Its U.S. Silicone Gel Filled Breast Implant Regulatory Activities and Clinical Studies
INAMED Corporation (NASDAQ:IMDC), a global healthcare company, today provided an update with respect to certain of its silicone gel-filled breast implant regulatory activities and clinical studies. The Food and Drug Administration (FDA) is currently reviewing the company’s responsive gel implant and its cohesive gel implant (BioDimensional(TM) Style 410 Matrix) premarket approval applications (PMAs).
Press Release
SANTA BARBARA, Calif.–(BUSINESS WIRE)–July 18, 2005–INAMED Corporation (NASDAQ:IMDC): Company modified its responsive gel implant PMA by:
- Separating data for round and Style 153 investigational devices
- Including 10-12 year European rupture prevalence data
- Company ends availability of Style 153 for U.S. clinical studies
- Company in final discussions with FDA for expanding access to BioDimensional(TM) Style 410 Matrix cohesive gel implant to supplant Style 153 breast implant
- Company intends to update its Style 410 PMA to include 3-year follow-up data and new 5-9 year European rupture prevalence data
INAMED Corporation (NASDAQ:IMDC), a global healthcare company, today provided an update with respect to certain of its silicone gel-filled breast implant regulatory activities and clinical studies. The Food and Drug Administration (FDA) is currently reviewing the company’s responsive gel implant and its cohesive gel implant (BioDimensional(TM) Style 410 Matrix) premarket approval applications (PMAs).
After consideration of the outcome of the April 2005 FDA Advisory Panel meeting and in consultation with the FDA, the company modified its responsive gel PMA by separating data for eight round and the shaped Style 153 investigational devices. This PMA modification also included new 10-12 year European data for these styles.
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