Contributed by Ron Gara| 13 April, 2005 04:02 GMT
An FDA advisory panel voted narrowly against recommending approval of Inamed's silicone gel breast implants. Mentor, an Inamed competitor, will make a presentation in support of its product's safety on Wednesday.
With some members citing the need for more information on risks associated with the rupture of silicone gel breast implants, the General and Plastic Surgery Advisory Panel of the US Food and Drug Administration (FDA) voted 5-4 against recommending approval of the devices manufactured by Inamed.
Silicone gel implants have been subject to market restrictions imposed by the FDA for 13 years due to concerns they might break and leak silicone, which could make women ill.
Although Inamed manufactures and sells its gel-filled implants internationally in more than 60 countries. in the US they have been restricted to patients undergoing reconstruction or revision surgery, and who also are participating in clinical studies.
Inamed shares fell 9.4% in after-hours trading.
Inamed Disappointed
"We believe our clinical data and related information comply with the FDA's revised guidance document for breast implant PMAs (premarket approvals), and therefore we are disappointed by the Panel's vote," said Nick Teti, Chairman, President and Chief Executive Officer of Inamed Corporation. "However, we intend to work with the FDA to address the PMA issues raised by the Panel during today's session."
Inamed's Style 410 cohesive gel-filled breast implants are the subject of a separate PMA and were not part of the PMA under consideration today by the Panel, Teti noted.
Mentor Crosses Fingers
Another breast implant maker, Mentor Corporation (NYSE:MNT), announced this evening that in its presentation to the advisory panel tomorrow, it plans to provide among other data, up to 12 years of evidence supporting the integrity of Mentor's Memory Gel silicone gel-filled breast implants.
Wednesday will be the third and final day of the advisory panel meeting.
"It's important to note that there are differences among breast implants as well as among the studies that support their safety and efficacy," said Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation. "We believe the advisory panel will weigh the scientific evidence and find that Mentor's silicone gel-filled implants are an important and safe option for women." |
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