Allergan and Mentor have won FDA approval to resume sales of silicone breast implants, reigniting a long-standing debate over safety of the devices.
The FDA said its decision to approve the implants was based on a thorough review of each company’s clinical and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels.
“The FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products,” said Daniel Schultz, director, center for devices and radiological health director, FDA. “The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices.”
During its announcement of the approval late Friday, the FDA said it would require Allergan and Mentor to conduct a large postapproval study to follow the progress of 40,000 women for 10 years after receiving breast implants.
Additionally, the FDA has mandated that patient labeling for the implants contain information conveying breast implants risks including hardening of the breast tissue, pain, shape and position change, lost sensation, muscle pain, fatigue and the likelihood of follow-up surgeries.
Silicone-gel breast implants were first sold in 1962, before the FDA required proof that all medical devices be safe and effective. In 1992 they were banned amid safety concerns. Cases of ruptures added to those concerns.
In 1995, Dow Corning, once the major manufacturer of silicone breast and other implants, faced 19,000 lawsuits related to its silicone breast implants, pushing the company into Chapter 11 bankruptcy. The company came out of Chapter 11 in 2004, after setting aside $2.35 billion to settle claims.