FDA Approves Saline Breast Implants from Two Makers
The implants, which are made of a silicone shell filled with sterile salt water, were approved for breast augmentation in women 18 years or older and for breast reconstruction.
FDA's decision was based on a review of the firms' clinical studies, on inspection of the firms' manufacturing facilities, and on the recommendation of the Plastic and Reconstructive Surgery Devices Panel of FDA's Medical Devices Advisory Committee (see related story).
In clinical studies, the companies looked at various short-term or "local" complications associated with the products, such as infection, hardening of tissue surrounding the implant (capsular contracture), leakage/deflation, and implant removal. The firms also looked at the effectiveness parameters of patient satisfaction, body esteem, self-esteem, and breast size. Altogether, some 9,000 women were enrolled in three McGhan studies and two Mentor studies.
"It's clear from these studies that there is a possibility that a substantial number of women who get these implants will require additional surgery at some point to remove or replace their implants because of complications," said David Feigal, director of FDA's Center for Devices and Radiological Health.
Despite the complications experienced by some, the majority of women still in the studies after three years reported being satisfied with their implants. However, this does not include women who had their implants removed due to problems and were dropped from the studies.
Saline-filled breast implants have been marketed for over 30 years, before FDA was given the authority to regulate medical devices. After questions began to arise about their safety in the 1980s, FDA decided to call for specific safety and effectiveness data from manufacturers.
McGhan said it will now seek approval for five styles of silicone gel-filled breast implants. Clinical trials are expected to begin shortly, and the company's PMA application should be submitted to FDA by the fourth quarter of 2002.
According to a Reuters news article, other companies that make saline breast implants must stop distributing the products after May 15.