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.”
Transvaginal Mesh Lawsuit
Submitted by Fred Levin on
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:
- Cystocele
- Rectocele
- Enterocele
- Vaginal Vault Prolapse
- Procidentia
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
- Pain
- Bleeding
- Mesh-related infections
- Pain during sexual intercourse (dyspareunia)
- Vaginal scarring or shrinkage
Resources
- 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
In The News
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.
Earlier this year, the United States Judicial Panel for Multidistrict Litigation issued an order that executed something never seen before in Multidistrict litigation: placing not one, but four (4) separate multidistrict proceedings in the hands of a single judge.
The Honorable Judge Carol Higbee of the New Jersey Superior Court has informed Johnson & Johnson that she will brook no more delays.
One of the standards used to determine liability in a personal injury case is whether or not the defendant knew, or should have known, that the cause of action would cause harm to the plaintiff. Another standard is whether or not the defendant failed in its duty to warn the plaintiff(s) about the hazards product or circumstances that led to the defendant's injuries.
