If a medical device is implanted in a patient, and afterward, someone at the company determines there are defects and issues a written memo suggesting improvements, can those memos constitute evidence against the company in a lawsuit for that patient's pain, suffering and medical expenses?
Transvaginal Mesh Lawsuit
Vaginal Mesh Recall
Pelvic mesh, also known as transvaginal mesh, is mesh that is surgically placed for the treatment of women's gynecological and urogynecological issues such as pelvic organ prolapse or stress urinary incontinence. Pelvic mesh is made of synthetic material, usually polypropylene, and is made of porous or micro porous weave. Some products even claim to have a "biologic element" made of a collagen blend.
Surgical mesh has been used in gynecology since the 1990's. By using the FDA's 510(k) expedited approval process, the mesh industry would produce dozens of these products each year without having to prove the safety or efficacy of these devices. In 2004, the industry began producing "pelvic organ prolapse kits" under the premise that these products were a safe and effective alternative to proven traditional surgical techniques.
Pelvic Organ Prolapse is the downward descent of the pelvic organs, usually after childbirth. Statistics show that pelvic organ prolapse affects approximately 50% of women who have given birth. Many treatments are available to treat pelvic organ prolapse, including surgical repair. Traditional surgical repairs are available to physicians and surgeons, either through Colporrhaphy (use of native tissue and sutures) or Sacrocolpopexy (laparoscopic surgery). Since the inception of mesh prolapse kits in 2004, doctors have increasingly turned to pelvic mesh over traditional surgery due to the false premise created by the mesh industry that mesh is a better alternative. In 2010, it is estimated that 100,000 pelvic organ prolapse procedures were performed using pelvic mesh.
In July 2011, the FDA issued heightened warnings regarding the use of transvaginal mesh for the repair of pelvic organ prolapse. Three months later, in September, 2011, an FDA panel recommended that pelvic organ prolapse mesh be reclassified to prevent any more clearance of these products through the 510(k) expedited clearance process.
Pelvic mesh is used to treat pelvic organ prolapse conditions known as:
- Vaginal Vault Prolapse
If you received a mesh product during a surgery to repair pelvic organ prolapse, that product could be responsible for serious complications such as:
- Mesh erosion
- Mesh-related infections
- Pain during sexual intercourse (dyspareunia)
- Vaginal scarring or shrinkage
- July 13, 2011 - FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
- October 20, 2008 - FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence
Devices Disfiguring Women
In The News
The media recently marked a grim milestone. The number of plaintiffs who have filed a vaginal mesh lawsuit has passed the thirty thousand mark. Approximately one third of these are scheduled to be heard in the U.S. District Court, Southern District of West Virginia. Vaginal mesh lawsuit cases currently involve six (6) separate Multidistrict Litigation dockets pertaining to six manufacturers: American Medical Systems, Boston Scientific, Coloplast, Ethicon, Cook Medical and C.R. Bard.
It should come as no surprise.
The first civil lawsuit against medical device maker C.R. Bard, manufacturer of the Avaulta Transvaginal Mesh, had been going on for little more than a week when it was revealed that the supplier of the plastic material used to manufacture the device had warned the company that their product – polypropylene – was unsuitable for use in the human body.
Those are the words of one Dr. David Grimes, who in July 2011, speaking to an NBC news reporter about the problems with pelvic meshes, added that “...we have a long history of accepting things without critical appraisal.”
LP attorneys Troy Rafferty and Robert Price write about the serious injuries resulting from medical mesh products in the latest issue of the Journal of the Florida Justice Association.
Learn more about Pelvic mesh lawsuits
In January 2013, yet another (!) lawsuit was filed in a Minnesota district court on behalf of a woman who received a pelvic mesh implant manufactured by Boston Scientific. This by itself is hardly news; litigation over pelvic slings has just gotten started. It's worth looking at the specific grounds of her lawsuit, however.
The complaint alleges negligence, failure to warn and defective design – as well as breach of “express” and “implied” warranties.
Recently, we discussed product liability for medical device manufacturers and medical malpractice on the part of physicians – and how in some cases, determining responsibility for a plaintiff's injury is not always simple.
They manufacture, market and sell prescriptions and medical devices they allegedly know to be harmful – then, when caught and called to the carpet on it, wind up paying out fines, penalties and settlements that amount to pocket change in relation to their multi-billion dollar profits (which they write off as the “cost of doing business”). Not one executive goes to jail.
If you have been prescribed a dangerous drug or received a defective medical device – such as a hip or joint implant or a pelvic mesh, both of which have been demonstrated to cause serious health problems – you understand that you have a right to sue the manufacturer for damages.