As reported by various sources including the UK’s Daily Mail, regulators for the U.S. Food and Drug Administration recently sent warning letters to two of the top breast implant manufactures for “failing to complete the safety studies” required for medical devices to remain on the market. The letters were issued just days before a new hearing that will be held on breast implant safety. The breast implants “have stayed on the market for years without adequate safety data, despite ranking in the highest risk bracket for medical devices.”
The letters and the new federal review of breast implants come amid growing concerns world-wide over silicone breast implant safety; the implants have been linked to autoimmune disorders as well as immune system cancer. Silicone implants were banned in the early 1990s, after a decade of attempts by regulators to get complete safety data from manufacturers were unsuccessful.
The companies responded with vigorous efforts to get the implants back on to the market, efforts that finally met success in 2006 despite the fact that complete safety data was still not provided. The FDA received only three years of data on the risks of rupture, leaks, scars contracting, difficulties performing mammograms around implants, links to lupus, and links to cancer, despite the fact that 10 years of data were required. “To this date, nobody has seen complete data from those studies the firms promised to complete.”
Through 2011, the omissions were accepted on the basis of the safety research being a work in progress. But amidst concerns from regulators around the world, the FDA published a new statement indicating the existence of strong evidence the silicone breast implants are linked to cancer of the immune system. In the years since, thousands of women have reported ruptures, scar contractions, cancer, and other adverse autoimmune reactions. At least 9 women have died, and over 450 have contracted the “rare” immune system cancer.
As the Daily Mail observed, “The FDA cites ‘several serious deficiencies in the manufacturer’s post-approval study’, including low numbers of patients involved, a poor follow-up rate, and data inconsistencies, particularly failure to account for racial and ethnic disparities.”
Lieff Cabraser’s Work on the Breast Implants Class Action
Lieff Cabraser served on the Plaintiffs’ Steering Committee and was one of five members of the negotiating committee in the historic In re Silicone Gel Breast Implants Products Liability Litigation, MDL No. 926 (N.D. Ala.) which achieved a $4.25 billion global settlement on behalf of implanted women. Over 100,000 breast implant recipients received payments, reimbursement for the explanation expenses, and/or long term benefits. Learn more about Lieff Cabraser’s work on the silicone gel breast implants class action.