Mentor Worldwide, a subsidiary of Johnson & Johnson, has been named in two new lawsuits involving its MemoryGel silicone breast implants. An attorney representing one of the plaintiffs recently told Bloomberg News that hundreds of women may be eligible file similar claims.
Mentor is one of three device makers that have been authorized to market silicone breast implants since the U.S. Food & Drug Administration (FDA) lifted restrictions on the devices in 2006. The other companies include Allergan Plc, and Sientra Inc. MemoryGel implants are approved for breast augmentation in women age 22 or older and for breast reconstruction in women of any age. They are also used in revision surgeries, which correct or improve the result of an original surgery.
According to Bloomberg News, a California woman filed suit earlier this month in Los Angeles Superior Court alleging that leaking silicone from her MemoryGel breast implants caused pain, nausea, skin rashes and extreme fatigue. She further claims that Mentor failed to provide patients and doctors with adequate warnings regarding the risks associated with the devices, and asserts that the company never performed proper safety testing as mandated by the FDA.
“We believe the problems with Mentor’s silicone implant are pervasive and may have harmed thousands of women,” her attorney told Bloomberg News “This suit may be just the tip of the iceberg.”
In September, another breast implant lawsuit was filed against Mentor in San Francisco federal court by a Seattle woman who also received Mentor’s MemoryGel implants. She claims the devices caused a range of ailments, including skin rashes, extreme fatigue and high levels of heavy metals in her bloodstream.
Silicone breast implants were the subject of massive litigation in the 1980s and 1990s, after thousands of woman claimed that the devices had caused autoimmune disorders and other problems. The litigation was eventually settled for billions of dollars, but not before Dow Corning was forced to file for bankruptcy. Dow and other device makers eventually left the silicone breast market.
The resulting safety controversy prompted the FDA to restrict silicone breast implants in 1992, which resulted in a near-ban of the devices for 14 years. Today, only five silicone implants are approved for use in the U.S.: