The first vaginal mesh recall goes back to the 1990s when Boston Scientific Corp. voluntarily took its ProteGen device off the market. Since then, Mentor Worldwide stopped production of its ObTape product in 2006 and just last year Johnson & Johnson took four of their mesh products off the market.
How has the Federal Drug Administration (FDA) responded to the obvious problems with these products?
In an official report in 2011, they admitted that mesh prolapse repairs resulted in thousands of injuries and seven deaths. Additionally, they found no evidence that mesh implants improve the results of prolapse surgery.
After this report, the FDA’s Obstetrics & Gynecology Devices Advisory Committee investigated the health risks of vaginal mesh implants. Shockingly, the panel refused to remove the products from the market. The only action taken was to reclassify the products as Class III, which means new products require pre-market approval. One last step taken by the FDA was to require mesh manufacturers to conduct three-year studies regarding the side effects of the implants.
What does the FDA’s inaction mean for victims of vaginal mesh injury?
The FDA’s failure to take these products off the market sends a message as to the seriousness of the victim’s complaint. The bottom line is you need a vaginal mesh injury victim lawyer. It is true that some companies have stepped up and taken accountability. In fact, Boston Scientific ended up settling more than 1,000 lawsuits over a decade after they removed their mesh from the market. However, you can be sure that these huge companies have their own team of attorneys focusing on what’s best for the company. You need your own advocate, an attorney with your best interests in mind. The fact is that the side effects from these untested products have resulted in pain and suffering and decreased quality of life for many women.
Presently, the first vaginal mesh trials are proceeding . Juries and the rest of the world are not learning the truth about the known defects in these systems. One such defect ignored by J&J that the mesh needed to be very lightweight with pores in one direction. Despite being told this, J&J proceeded with a different design that was unreasonable dangerous to women.
If you are a victim of vaginal mesh injury, you are entitled to compensation. The FDA’s failure to pull these products from the market have resulted in even more injury. Trust The Levensten Law Firm to be your advocate. Contact us for a consultation.