There were a few more indications last month that at least some transvaginal lawsuit defendants may face criminal charges. A few months ago, the consumer advocate organization Corporate Action Network called upon U.S. Attorney General Eric Holder to initiate a criminal investigation into allegations that Johnson & Johnson, parent company of mesh manufacturer Ethicon, engaged in obstruction of justice when documents relating to its products went missing.
Robert Price, a vaginal mesh lawyer with the Levin, Papantonio law firm, is currently reviewing cases where patients suffered complications and injuries from an implanted transvaginal mesh device.
Transvaginal mesh, also known as pelvic mesh, is a mesh device that is surgically placed for the treatment of women's gynecological and urogynecological issues, such as pelvic organ prolapse or stress urinary incontinence. Transvaginal 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.
Vaginal Mesh Recall
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.
Vaginal Mesh Warnings
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
Vaginal Mesh Lawyer
If you or a loved one suffered injuries from a vaginal mesh implant, please contact us to have an experienced vaginal mesh lawyer review your or your loved one's situation to determine if a transvaginal mesh lawsuit can be filed.
- 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
In The News
Despite its attempts to have the judgment in a transvaginal lawsuit overturned, Johnson & Johnson subsidiary Ethicon is still on the hook for over $11 million.
Endo, a subsidiary of American Medical Systems, recently announced that it will be paying out $830 million to settle around 20,000 transvaginal mesh lawsuit actions pending against it in multidistrict litigation. This is on top of over $54 million paid out last year as well as over $1 billion the company is holding in reserve to cover its legal costs.
It doesn't happen very often, but when it does, it's big news – and can have serious ramifications for the defendant.
It's when civil litigation leads to a criminal investigation. For example, if evidence in a wrongful death lawsuit indicates that the defendant acted willfully, and these actions led to the victim's demise, that defendant could wind up facing murder charges.
While the number of transvaginal mesh lawsuit cases in the U.S. has now passed the 60,000 mark, incredibly, many doctors are continuing to use them. In most cases, these meshes are used to treat urinary stress incontinence (this method is widely called using a “bladder sling”). Most doctors still prefer using “bladder slings,” which they still view as safer and more effective than traditional procedures.
“Right! This calls for immediate discussion!”
- John Cleese in Life of Brian
At this point in time, anyone attuned to the news surrounding transvaginal mesh lawsuits has heard of several large verdicts surrounding Pelvic Organ Prolapse (POP) mesh kit litigation.
However, in 2014, there are multiple trials set for the mass of TVM cases out there – the Stress Urinary Incontinence (SUI) sling meshes (also known as “Bladder Slings”). The question for most people involved in a transvaginal mesh lawsuit is “what is going to happen with the SUI Sling/Bladder Sling cases?”
For every woman who has filed a transvaginal mesh lawsuit, some vindication may be on its way.
Recently, the U.S. Food and Drug Administration proposed new restrictions on the use of vaginal meshes for the treatment of pelvic organ prolapse. These more stringent safety regulations would move such use of transvaginal meshes from the moderate risk (class 2) to the high-risk category (class 3).
The Texas woman who identified herself only as “Barbara” hasn't had it has bad as some women. For many vaginal mesh lawsuit plaintiffs, there have been numerous revision surgeries, disabling pain and complete inability to engage in the sex act.
“Barbara” had her first vaginal mesh implanted in 1996 to treat urinary stress incontinence. She was informed that the procedure would help her deal with the problem for ten years before another surgery would be necessary. She experienced mild discomfort over that time, but says it was “nothing I couldn't live with.”
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?