FDA Panel Backs Mentor Breast Implant

In a surprise move, a federal advisory panel on Wednesday approved a silicone-gel breast implant made by Mentor(MNT Quote), one day after rebuffing a similar device from Inamed(IMDC Quote).

If the Food and Drug Administration follows the lead of its advisory panel, the Mentor product would be the first silicone-gel implant approved for widespread use in the U.S. since 1992. The advisory committee voted 7-2 for the product.

The FDA usually follows the recommendations of its advisory panels, but it isn't bound by their suggestions. In October 2003, for example, an advisory panel endorsed an Inamed silicone-gel implant by a 9-6 vote; but the FDA voted against approving the device in January 2004. The FDA said the company didn't prove that the product would be safe over time.

Long-term safety was the key reason the advisory committee on Tuesday voted 5-4 against the latest Inamed application. Analysts who follow the two implant companies said they believed Inamed had a better chance of gaining advisory committee approval.

The advisory committee's decision on Wednesday sent Mentor's stock rising in after-hours trading. In regular trading, the stock closed up 77 cents, or 2.2%, to $35.33. But after hours, the stock gained another $3.87, or 11%.

Meanwhile, Inamed's stock suffered. In regular trading, it fell $2.90, or 4.4%, to $63.51. After hours, it lost another $3.21, or 5.1%.

The advisory panel attached an assortment of conditions to its recommendation, according to wire service reports. For example, it said Mentor could only sell the implants to board-certified plastic surgeons who complete special training, and to patients who sign documents showing they understand that the implants could rupture.

Mentor also must prepare a patient registry to assess the long-term results of the device and conduct a clinical study to track the implant rupture rate over 10 years.