The Johnson & Johnson subsidiary, Ethicon, now has company in being sued for defective tranvaginal mesh devices. A new lawsuit filed by a Wisconsin woman alleges that the Pinnacle Pelvic Floor Repair Kit, by Boston Scientific, is “defective and caused her a number of serious injuries.”
Transvaginal mesh devices are marketed as a means to “repair weakened or damaged tissue” and is “permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse.” But the mesh implants have some very serious effects on patients, actually doing the opposite of their intended purpose. According to the U.S. Food and Drug Administration, complications associated with the device include mesh erosion through the vagina, infection, bleeding, and organ perforation.
Boston Scientific is being sued for “negligence on three counts of strict liability – including design defect, manufacturing defect, and failure to warn.” This is the latest development in a string of lawsuits connected to transvaginal mesh implants. One of the more recent suits filed against Ethicon for its Gynecare Prolift vaginal mesh implant, where Ethicon was ordered to pay out $3.35 million. That’s also not including the $16.75 million it may have to pay in punitive damages.
“This verdict establishes that Johnson & Johnson and Ethicon failed to tell physicians and women the truth about the catastrophic complications that can result from the Prolift,” said the South Dakota plaintiff’s attorney.
This case was the first in a line of about 2,100 lawsuits against Ethicon for the Prolift product.
The FDA has ordered over 30 makers of vaginal mesh products to engage in “post-market safety tests” that better explain and detail the dangers that the manufacturing companies have swept under the rug from patients and doctors. This is a common practice among pharmaceutical and medical companies. The companies can even shirk the FDA approval process by going through its 510(k) expedited approval, which isn’t really an “approval” in the actual sense, but rather, a mere “rubber-stamp” clearance for marketing.
“The interesting thing about this product (the Prolift), and about Ethicon’s, which is essentially Johnson & Johnson’s behavior, is that they didn’t even go to the FDA with this product,” said Robert Price, a transvaginal mesh litigation attorney with Levin, Papantonio, Thomas, Mitchell, Rafferty, & Proctor, P.A. “They saw another product on the market . . . by a competitor, American Medical Systems, and before even going to the FDA, Johnson & Johnson just decided to put this thing out on the market and then go get clearance three years later.”
Patient well being is not a priority for companies like Ethicon. They see medicine as a competition where the “winner” is the one that can distribute faster and sell more products with absolutely no consideration for the health of their consumer base.
Joshua de Leon is a writer and researcher with Ring of Fire.