Breast Implant Co. To Boost Quality
May. 05, 1998
WASHINGTON (AP) _ A California breast implant manufacturer agreed to significantly upgrade its quality controls in a consent decree filed with the Food and Drug Administration Tuesday.
Mentor Corp. makes saline-filled breast implants and some silicone-gel breast implants.
The consent decree was not prompted by problems with Mentor implants, and there's no reason that women who have Mentor-made implants should worry, said FDA medical device chief Dr. Bruce Burlington.
FDA regulations require that medical device makers institute specific manufacturing processes that help ensure defective products don't come off the assembly line.
The FDA had attempted for several years to get Mentor to upgrade its manufacturing to meet the quality rules. The company wasn't upgrading fast enough, so the FDA went to court to negotiate the consent decree, Burlington said. The decree requires Mentor to be in full compliance with FDA regulations by the end of the year.
After thousands of women claimed they were sickened by leaking gel implants, the FDA in 1991 restricted silicone-gel implants to breast cancer patients who receive them in special scientific studies. Until this month, Mentor was the only company offering silicone implants to breast cancer patients. Saline implants are widely available.
Manufacturers of silicone implants face thousands of lawsuits. Many scientific studies have found no increased risk of serious diseases. But local complications, such as hardening of the breast, are well-known when implants leak.
``Mentor has made a commitment to make sure they are upgrading their quality so future implants are going to be better manufactured, with the goal of reducing the chance of leakage,'' Burlington said.
Mentor said in a statement that it agreed to the quality improvement program, which it said would also help increase productivity.