21 septembre, 2005 13:23
FDA: Inamed breast implants 'approvable'
SEP. 21 9:57 A.M. ET Medical device maker Inamed Corp. confirmed Wednesday that the Food and Drug Administration said its silicone gel breast implants will be approved as long as the company adheres to a number of conditions.
Shares of Inamed surged 8.6 percent to a new 52-week high of $77.19 in morning trading on the Nasdaq. The shares have traded over the past year in a range of $45.17 to $75.38.
The announcement comes nearly two months after rival Mentor Corp. said it received an "approvable" letter from the FDA for their silicone gel breast implants. Shares of Mentor fell $1 to $51.56 on the NYSE.
Silicone gel breast implants have been banned from the U.S. market for 13 years after thousands of women claimed that leaking implants damaged their health. Saline-filled implants remain on the market, but some consumers have sought the return of silicone-gel implants because they look and feel more natural.
In April, both companies' marketing applications were reviewed by a panel of scientific advisers convened to discuss reintroducing the implants to the market. While Mentor got high marks from the panel, Inamed did not.
Inamed said the conditions for approval outlined in the letter are generally in line with recommendations made by FDA advisory panels. The panels have stipulated that companies must ensure that women understand the devices could leak internally with no outward signs, recommend that women get regular MRI exams to check for breaks, allow only specially trained plastic surgeons to place the implants, and conduct new studies to prove how long implants last.
The company said it will meet with the agency privately to discuss points addressed in the approvable letter.
