On October 19, 2017, Mentor Worldwide LLC, announced the release on the U.S. market of a new silicone breast implant: the MemoryGel Xtra. However, many plaintiffs who sued the company, keep claiming that the purportedly safe devices caused them serious injuries, life-threatening diseases and severe discomfort.

According to Mentor, the newest MemoryGel Xtra allows for increased firmness and softness to produce the fully natural feel desired by many women. This latest implant follows the launch of the Artoura Breast Tissue Expander line in July 2017, and has been approved by the Food and Drug Administration (FDA) in April 2017. The manufacturer also claims this implant is more protective, reducing the chance that the capsule breaks, leaking silicone over nearby tissues.

Together with Allergan Inc., today Mentor is the only company allowed to produce silicone devices used for breast reconstruction and cosmetic breast augmentation. Back in the 1980s and 1990s, in fact, many women who received the implants quickly started suffering from serious adverse reactions such as rheumatoid arthritis. Many devices also ruptured or broke, releasing their fluids and causing severe tissue inflammation. In 1992, the regulators eventually banned their use and a storm of lawsuits hit the manufacturers, causing many of them to file for bankruptcy.

Many years later, in 2006, the FDA thought that lifting the ban was a good idea since the evidence showing that silicone breasts were harmful was deemed inconclusive. The agency decided to grant permission to the two corporations cited above to distribute the new implants on one condition, however. That at least 6 clinical trials had to be run to confirm the new breast implants’ safety. More than 11 years have passed, but to date, no study has ever been submitted. It’s unclear whether the manufacturers actually play possum, or simply found that the silicone devices are all but safe and decided to conceal the data. Many lawyers are currently trying to provide many state and federal courts with evidence of the latter hypothesis, though.

In 2011, the FDA collected almost 400 adverse reaction reports from patients who developed a rare form of cancer called anaplastic large cell lymphoma (ALCL) after receiving a Mentor implant. In 9 of these reports, the patient eventually died. Today, a new wave of litigations is currently being filed by patients who suffered the many harmful side effects of a silicone breast. Breast implant rupture suits are becoming more and more common every day, and plaintiffs claim that Mentor and Allergan negligently distributed a dangerously defective device in the market.

Article by Dr. Claudio Butticè, Pharm.D.