Johnson & Johnson and its Ethicon subsidiary unit Mentor Worldwide are accused of selling defective breast implants that can rupture, leak silicone, and make women sick.
Lawsuits have been filed by women who suffered health problems such as muscle pain, nausea, extreme fatigue, skin rashes, and bloodstream poisoning with heavy metals used in manufacturing.
Two lawsuits have now been filed in California by women who were injured by Mentor MemoryGel Silicone Gel-Filled Breast Implants. The first lawsuit was filed in federal court in San Francisco in September 2016 by a woman from Seattle named Sara Ebrahimi.
On February 2, another lawsuit was filed by Rexine Mize in California Superior Court. Her lawyer, Jaime Moss, 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.”
U.S. regulators banned the use of silicone-based breast implants in 1992 after a wave of litigation in the 1980s and 1990s. Hundreds of thousands of lawsuits were filed by women who said the implants caused cancer, Rheumatoid arthritis, and other serious side effects.
Mentor Worldwide was the first company to put silicone breast implants back on the market after the FDA lifted its 14-year ban in 2006. Johnson & Johnson bought Mentor for $1.1 billion in 2008.
As a condition of approval, the FDA required Johnson & Johnson to conduct several 10-year studies. Just three years into those studies, researchers “lost track” of 79% of women who enrolled at the start.
The studies were supposed to track about 80,000 women, but the results will be useless with such as low participation rate. The FDA proposed recalling silicone breast implants due to a lack of long-term safety data, but rejected a recall after an advisory meeting in 2011.
Lawyers for Mize say her injuries could have been prevented if Mentor had actually completed those safety studies. They accuse the company of failing to warn about “the risk of serious defects and life-altering complications” from the leaking implants.
Mentor, Allergan, and Sientra are the only companies allowed to sell silicone breast implants in the U.S. — and all of them could face lawsuits from women who were injured by leaking breast implants.
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.