Silicone Breast Implants- Mentor MemoryGel Lawsuit

Many women with Mentor MemoryGel Breast Implants claim the silicone gel in the implants are leaking dangerous chemicals into their bodies, and could potentially cause serious health risks. The Silicone breast implant lawsuits allege that Mentor Worldwide failed to comply with FDA regulations stipulating that the medical device company must conduct proper studies of all of the health risks associated with its MemoryGel breast implants.

In the late 1990s Dow Corning was almost a household word. Thousands of women filed lawsuits claiming the implants leaked and caused numerous diseases, including cancer and rheumatoid arthritis. The company was ordered to pay $3.2 billion dollars to women who had a ruptured or leaking breast implant, which led to its bankruptcy. Years later the Institute of Medicine and the FDA found that the breast implants do not cause major illnesses.

The Rheumatologist (December 2016) Journal published an article by Osteopathic physician Charles Radis titled “Lupus or Mass Somatization?” in which Radis told of the first silicone breast augmentation in 1962 and how the procedure was common over several decades for both cosmetic purposes and to repair cancer-related mastectomies. By the early 1980s Ralph Nader’s Public Citizen Health Research Group warned a possible link between implants and cancer. The first breast implant lawsuit against Dow Corning, claiming autoimmune disease could arise from silicone breast implants, was filed in 1984.
  The FDA banned the manufacture of silicone breast implants in 1992 but lifted its ban at the end of 2006, when it pre-approved Mentor to manufacture and sell their silicone breast implants on condition that it undergoes six safety studies. Mentor has reportedly not submitted those proper studies to the agency. The studies were supposed to track about 80,000 women, but after only three years, Mentor said it had “lost track” of 79 percent of women who had enrolled in the studies.

Mentor Worldwide LLC, a subsidiary of Johnson & Johnson, calls its silicone breast implants Memory Gel. (J&J paid $1.1 billion for Mentor in December 2008, after it became the first company allowed to put silicone implants back on the market.) Complaints allege that dangerous chemicals and heavy metals are leaking either microscopically through the silicone membrane or in the event of a rupture, leaking out of the implant itself.

The MemoryGel Silicone-Filled Breast Implants have a silicone outer shell that is filled with silicone gel. They are approved for breast augmentation in women age 22 or older, for breast reconstruction in women of any age and for use in revision surgeries, which correct or improve the result of an original surgery.

The New York Times (November 2006) reported that Mentor was already advertising its product online, called Mentor4Me.com, before the FDA lifted its 14-year ban on the use of silicone gel breast implants in the US.

Mentor, along with Allergan Plc and Sientra Inc. are the only companies the FDA has authorized to market the devices.
  In September 2016, a Seattle woman filed a lawsuit against Mentor and J&J in federal court in San Francisco. Sara Ebrahimi claimed MemoryGel silicone caused skin rashes, extreme fatigue and left her bloodstream laced with heavy metals used to manufacture the devices. The case is Sara Ebrahimi vs. Mentor Worldwide LLC — Case No. 2:16-cv-07316.

A second Mentor lawsuit was filed by a woman in California. Rexine Mize claims the implants leak, causing her and other women a number of health problems, including long periods of muscle pain and nausea. Lawyers for Mize argue that her injuries could have been prevented if Mentor completed the six safety studies required by the FDA. The case is Mize v. Mentor Worldwide LLC, No. BC-649083, California Superior Court (Los Angeles).

Another lawsuit was filed in Washington State and many more are expected, according to plaintiff attorneys (above). The silicone breast implant lawsuits all claim that Johnson & Johnson failed to conduct proper studies to warn both patient and physicians of the potential risks involved with the breast implants.
 

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Last updated on May-26-20