February 7, 2017 — Two lawsuits have been filed in California by women who got sick when their Mentor MemoryGel silicone breast implants leaked.
Mentor Worldwide was the first company to re-enter the silicone breast implant market after the FDA lifted a 14-year ban on the implants in 2006. Johnson & Johnson bought Mentor in 2008.
The company is facing two lawsuits from women who were injured — but lawyers say many more women have been injured.
The first lawsuit (PDF) was filed in September 2016 by Sara Ebrahimi, a woman from Seattle who says she experienced a wide range of side effects, “all of which indicated a systemic toxicity due to her body’s reaction to the toxic elements contained within the gel of the implants.”
The lawsuit was filed in the U.S. District Court for the Central District of California (San Francisco) — Case No. 2:16-cv-07316.
On February 2, a second lawsuit was filed in California. The plaintiff, Rexine Mize, claims her leaking breast implants caused muscle pain, nausea, fatigue, skin rashes, and other side effects. Her lawyer told Bloomberg:
“We believe the problems with Mentor’s silicone implant are pervasive and may have harmed thousands of women. This suit may be just the tip of the iceberg.”
The lawsuit was filed in California Superior Court (Los Angeles) — In RE: Mize vs. Mentor Worldwide LLC — Case No. BC-649083.
Silicone gel-filled breast implants were banned in the U.S. in 1992 after hundreds of thousands of lawsuits were filed in the 1980s and 1990s by women who suffered side effects like cancer and arthritis.
As a condition of the FDA lifting its ban on silicone breast implants, Mentor Worldwide was required to conduct several long-term safety studies. Only 3 years into those studies, the company “lost track” of 79% of women who had enrolled in the studies.
When the FDA learned that the low participation rate would make the study results all but useless, the agency proposed recalling all silicone breast implants on the market. However, in 2011, the FDA rejected the recall after an advisory panel meeting.
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