According to a story in About Lawsuits.com, a woman from Louisiana has filed a lawsuit against Boston Scientific after she says she was injured and debilitated by the Pinnacle Pelvic Floor Repair Kit made by Boston Scientific.
The woman, Minnie V. Mann, says in her complaint that the synthetic mesh is defectively designed, the basis for a product liability lawsuit that was filed in U.S. District Court for the Western District of Louisiana on October 5. Mann claims she received the implant in January 2010 to treat incontinence and vaginal vault prolapse. She says she has experienced emotional distress, past and future medical expenses, pain and suffering, disability, and the loss of the enjoyment of life.
Boston Scientific is one of nine companies that make synthetic pelvic mesh. An FDA notification July 13, 2011, questioned for the first time whether surgical mesh for transvaginal repair of POP (pelvic organ prolapse) is more effective than traditional repair that involves non-mesh or sutures. And it said serious complications associated with surgical mesh are “not rare”.
Complications may include mesh eroding through the vagina, pain, infection organ perforation, urinary problems and bleeding, a recurrence of the symptoms and nerve damage, among other symptoms.
The FDA in its advisory said abdominally placed mesh had lower rates of complications compared to transvaginal POP surgery through the vagina.
Despite the warnings about 75,000 woman had transvaginal mesh surgery last year. There are about 600 lawsuits filed against various manufacturers.
There was a recall of about 540 Boston Scientific Pinnacle kits in August 2011 because of a defect that allowed the needle to detach during surgery because of low tensile strength between the needle and the suture in the pre-packaged mesh kits. Here is the recall notification.
In September, an FDA advisory panel met to determine whether synthetic surgical mesh for pelvic organ prolapse should be reclassified to a high-risk Class III medical device, which would require premarket approval. The panel has yet to make a recommendations to the FDA, which usually follows its expert’s advice.
The Patriot Ledger reports two new federal lawsuits have been filed against Boston Scientific Corp., just the latest of a long line of actions filed over the medical device synthetic mesh. Plaintiffs Veronica Rector of Tennessee and Rosemary Robinson of Kansas are represented by Cambridge lawyer William Hunt. The lawsuits were filed in Boston federal court, October 19, Wednesday. Both women say they are permanently injured by the Pinnacle or Advantage mesh made by Boston Scientific.
The Madison St. Clair Record reports that a Madison County woman, Susan Tallerico and her husband, Richard, have filed a lawsuit against a hospital and doctor who treated her with surgical mesh to treat incontinence. The suit was filed September 27, in Madison County Circuit Court against American Medical Systems, the maker of the Monarc mesh, Dr. Travis L. Bullock, and Anderson Hospital, in Maryville, Illinois, owned by Southwestern Illinois Health Facilities Inc. . Ms Tallerico says she sought treatment for urinary incontinence two years ago and Dr. Bullock improperly implanted the Monarc synthetic mesh which has causes Tallerico numerous and ongoing medical problems. The couple say they have spent more than $200,000 in medical bills and are seeking compensation for loss of consortium and court costs. The Circuit Court Case Number is 11-L-970 and Tallerico is represented by Michael Aschenbrener of Chicago and Mark Mueller of Austin, Texas.