You may recall back in the late 1980s and early 1990s, there was an avalanche of litigation stemming from leaking breast implants. These silicone implants did not last as manufacturers promised they would, and there were also accusations that companies failed to warn consumers of the possible hazards caused by ruptured implants. These included pain and soreness, change in breast size or shape and may be connected to joint problems, such as rheumatoid arthritis.
All this led to the U.S. Food & Drug Administration banning manufacture of silicone breast implants for nearly 15 years. That ban was lifted in 2006, with the FDA agreeing to authorize just three companies to sell silicone implants in the U.S. Last year, the breast implant market generated about $635 million – and 8 out of 10 customers opted for silicone implants.
Now, one of those companies, a subsidiary of Johnson & Johnson, is the target of litigation that some are saying could be the “tip of the iceberg” for a new onslaught of personal injury claims.
The product liability lawsuit filed against Mentor Worldwide alleges the company sold defective breast implants that cause a myriad of problems for patients, including severe muscle pain and nausea.
The personal injury action was filed in a state court in Los Angeles, California, though many others could follow, particularly if this case is successful. Plaintiff alleges the company did not do proper diligence in conducting adequate studies of the potential health risks of these silicone-based implants, as required by government regulators. Instead, plaintiff contends the company, seeing an opportunity for enormous financial gains, simply rushed the implants to market.
An attorney for plaintiff said it’s her belief, after conducting extensive research into the issues affecting her client, that the alleged issues with this particular brand of silicone implant are actually pervasive, and in fact may have harmed thousands of woman – some of whom may not yet realize the cause of their ailments.
The FDA lists many local complications and adverse outcomes that may result from breast implants – both silicone and saline – that include:
- Breast pain;
- Implant displacement or malposition;
- Redness/ bruising/ scarring;
- Necrosis (dead tissue around the breast);
- Infection, including Toxic Shock Syndrome;
- Seroma (collection of fluid around the breast);
- Swollen/ enlarged lymph nodes;
- Hematoma (collection of blood near the surgical site).
These issues are more often than not the result of medical malpractice, which would mean action taken against a physician, particularly if complications are severe and/or require revision surgery.
However, issues pertaining specifically to product liability, that is, the defectiveness of the implant itself, might include:
Ruptures (particularly within a relatively short period of time).
The FDA does require breast implant manufacturers to conduct ongoing studies to learn more about the long-term performance and safety of their devices. Of course, it’s highly unlikely that any research commissioned by these companies will red flag any major concerns. More likely than not, the truth will emerge in the course of these lawsuits, where independent research and sworn depositions are more likely to produce truthful, unbiased answers. That’s part of the reason we’re watching this case closely.
Call Freeman Injury Law — 1-800-561-7777 for a free appointment to discuss your rights. Now serving Orlando, West Palm Beach, Port St. Lucie and Fort Lauderdale.
Johnson & Johnson Unit Sued Over Leaking Breast Implants, Feb. 3, 2017, By Jef Feeley and Edvart Pettersson, Bloomberg
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