breast reconstruction breast augmentation FDA Approval

the U.S. Food and Drug Administration (FDA) has approved for sale the Company's MemoryGel(TM) silicone gel-filled breast implants with post-approval conditions. The products are indicated for women undergoing breast reconstruction and for women who are at least 22 years old undergoing breast augmentation.

"At this historic moment for Mentor, we would like to recognize with gratitude the dedication of the patients, nurses, and surgeons who have participated in the studies that provided the clinical and scientific support for this approval,“ said Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation. “Over the past 14 years we have remained devoted to returning MemoryGel(TM) implants to the U.S. market, and we are pleased to be able to provide women seeking breast augmentation and reconstruction with important new options."

The post-approval conditions and other requirements associated with the FDA's approval include the following: continue the ongoing Mentor Core Study through 10 years, provide physician training to access the device, conduct a large post-approval study for 10 years, complete additional device failure studies, conduct a focus group with patients on the format and content of the approved labeling, utilize a formal informed decision process with patient labeling, cease new enrollment in the Mentor Adjunct Study, and implement device tracking.

Silicone breast implants will be widely available in the United States for the first time in 14 years after U.S. health officials approved sales by two companies on Friday.

Mentor Corp. (MNT.N) and Allergan Inc. (AGN.N) each must study the implant risks in 40,000 women for 10 years, the Food and Drug Administration said. Silicone breast implants were banned for most U.S. women in 1992 after some complained the devices leaked and made them chronically ill.

FDA officials said the companies had provided "reasonable assurance of the benefits and risks" that would enable women to make informed decisions.

"We now have a good understanding of what complications can occur and at what rates. We also know that women who get these devices will probably need to have additional breast implant surgery at least once," said Dr. Daniel Schultz, director of FDA's Center for Devices and Radiological Health.

Breast pain, hardening of the area around the implant, change in nipple sensation, implant rupture and the need for additional surgery all were reported in the companies' studies, the FDA said. Still, most women said they were happy with the implants.

Mentor's data tracked women with implants for about three years, while Allergan's followed women for four years, the FDA said.

Independent research over the past decade has found no convincing evidence that breast implants were associated with connective tissue diseases or cancer, the FDA said. The manufacturers' post-approval studies are expected to further examine those issues.