Boston Scientific Corp. is currently facing two vaginal mesh lawsuits, a medical device used to treat incontinence and pelvic organ prolapse. This is just two in a long-line of similar suits filed against medical device manufacturers.
Complaints were filed in Boston by Cambridge lawyer, William Hunt, on behalf of Veronica Rector of Tennessee and Rosemary Robinson of Kansas.
The two women claim that they were painfully and permanently injured by either the Pinnacle or Advantage mesh products made by the company. However, few details about the cases have been released to the public.
The lawsuit claims that the products had a number of defects including a tendency to migrate from their implant location. The suit alleges that the products failed to address the original problem in which they were intended to fix.
A Boston Scientific spokesman declined to comment, citing a company policy against speaking about pending litigation.
Vaginal mesh is a synthetic mesh used to treat pelvic organ prolapse (POP) and stress urinary (SUI) which commonly effect women. Pelvic organ prolapse occurs when the pelvic organs slip out of place and descend into the vagina. This can happen after a woman has had multiple childbirths or a hysterectomy. The most common organ that is affected is the bladder.
SUI is a condition in women where they involuntarily loose urine during physical activity like laughing, coughing sneezing, or exercising. Many older women suffer from this condition, but many younger women can also suffer from it.
Both of these conditions can be treated with transvaginal mesh. However, there are many other alternative, non-surgical treatments available. Patients should discuss all treatment options with their physicians before deciding to undergo a vaginal mesh procedure.
The United States Food and Drug Administration (FDA) issued its first vaginal mesh warning 2008, advising patients of potential dangers the FDA deemed rare, but serious. Physicians were also required to receive specialized training on how to correctly implant the device.
In 2011, the FDA amended their warning, stating that the risks of vaginal mesh do not outweigh the benefits, citing more than 2,000 well-documented manufacturer complaints. The complaints were evenly split between patients who had the implant to treat POP and SUI.
Some of the complications include but are not limited to: bleeding, infection, painful sexual intercourse, mesh migrations, mesh shrinkage, and painful urination. Many of these complications require additional corrective surgeries, however because vaginal mesh is designed to allow human tissue to grow into the product itself, it becomes very difficult to remove.
According to Bloomberg, companies that make these devices collectively face more than 600 lawsuits from women who say that they were injured by the implants.