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Leaking Silicone Breast Implant Lawsuits Filed in California

Leaking Silicone Breast Implant Lawsuits Filed in California

February 7, 2017 — Two women who got sick when their Mentor MemoryGel silicone breast implants leaked have filed lawsuits in California against Johnson & Johnson.

The first lawsuit (PDF) was filed in San Francisco by a woman from Seattle. She blames a variety of health problems on “systemic toxicity due to her body’s reaction to the toxic elements contained within the gel of the implants.”

The lawsuit was filed on September 28, 2016 in the U.S. District Court for the Central District of California — In RE: Sara Ebrahimi vs. Mentor Worldwide LLC — Case No. 2:16-cv-07316.

The second lawsuit was filed last week by a woman who claims her Mentor MemoryGel breast implants leaked silicone and caused severe pain, chronic fatigue, nausea, skin rashes, and other health problems. Her attorneys 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 on February 2, 2017 in California Superior Court (Los Angeles) — In RE: Mize vs. Mentor Worldwide LLC — Case No. BC-649083.

Mentor Worldwide was the first company allowed to start selling silicone breast implants in the U.S. after the FDA lifted a 14-year ban on the devices in 2006. Johnson & Johnson bought Mentor in 2008. Mentor is now part of the company’s Ethicon medical device unit.

The problem is that Mentor failed to adequately complete long-term safety studies required by the FDA as a condition of returning the devices to the market. The FDA required several 10-year follow-up studies involving 80,000 women — but only 3 years into those studies, Mentor “lost track” of 79% of women who enrolled in the studies.

The low participation rate makes the outcome of those studies all but useless. The FDA was so concerned that it proposed recalling silicone breast implants. In 2011, the FDA rejected a recall after an advisory meeting, allowing the devices to remain on the market.

Two lawsuits may indeed be the tip of the iceberg. The FDA banned silicone breast implants because hundreds of thousands of women who were injured filed lawsuits in the 1980s and 1990s, forcing Dow Corning Corporation into Chapter 11 bankruptcy in 1995.

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