Johnson & Johnson’s Mentor Worldwide unit has found itself the subject of a lawsuit alleging that it sold breast implants that have caused a host of health problems for at least one patient.
According to a report in Bloomberg, the lawsuit is the first related to these specific silicone-based implants. It stems from a string of complaints by a woman who says that leaks from the implants gave her muscle pain and nausea.
Silicone breast implants have long been the subject of controversy, perhaps much of it unfounded. In fact, some point to silicone breast implants as a case study in government regulations run amok.
Mentor MemoryGel breast implant. (Image credit: AP)
In the 1980s, the U.S. Food and Drug Administration (FDA) classified the implants “high risk,” despite the ubiquitous use of silicone in a range of medical devices. Tort lawyers soon pounced, leveling thousands of lawsuits against manufacturers and surgeons. The financial pressure of the lawsuits was so massive that Dow Corning, the leading manufacturer of silicone products, ultimately filed for bankruptcy.
Then in 1999 a scientific review of silicone came to the conclusion that the breast implants did not “provide a basis for health concerns.”
Even though the FDA once again began allowing companies to sell silicone breast implants in 2006, the industry was spooked. Today, only three companies — including Mentor — are currently in the market.
This most recent case could trigger a renewed wave of litigation against silicone breast implants, one of the lawyers involved in the Mentor case told Bloomberg.
“We believe the problems with Mentor’s silicone implant are pervasive and may have harmed thousands of women,” the lawyer said. “This suit may be just the tip of the iceberg.”
Lawyers in the case allege that Mentor did not conduct the necessary safety assessments of the implants and did not warn patients about possible health complications. The patient in the case says she suffered extreme fatigue, nausea, skin rashes, and pain after her implants leaked.
Filed Under: Industry regulations
