The government has issued a warning about the use of transvaginal surgical meshes to treat pelvic organ prolapse and urinary leakage. Thousands of women have reported serious complications including organ perforation, pain, bleeding, infection, and urinary incontinence. In some cases the mesh - also called a bladder sling, pelvic sling or pelvic support - has
eroded or shrunk after being inserted, requiring additional surgeries. As a result, hundreds of lawsuits have been filed against the manufacturers of the transvaginal mesh products; including Ethicon Inc., a New Jersey subsidiary of Johnson & Johnson, which on June 4, 2012, said it would halt sales of most of its mesh products.
We trust our physicians to treat our illnesses and ailments, and physicians, in turn, trust pharmaceutical companies and medical device manufacturers to provide them with safe, reliable treatment options. When a medical device used in the course of treatment is found to be damaging, the company issuing the device can be held liable. Such is the case with transvaginal mesh.
What is transvaginal mesh?
Used as a treatment for weakened pelvic muscles such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women, transvaginal mesh is made of polypropylene and is designed to be a permanent implant. Developed in the late 1990's, transvaginal mesh became a leading method of treating these gynecologic conditions, and hundreds of thousands of women had the devices implanted.
What are the complications from transvaginal mesh?
Unfortunately, transvaginal mesh has proven to be a dangerous and damaging course of treatment for POP and SUI. Not all women experience every symptom of complication from the insertion of transvaginal mesh, but among the symptoms are:
- Nerve damage
- Vaginal scarring
- Painful sexual intercourse
- Recurrence of prolapse or incontinence
- Neuro-muscular damage
More severe complications for this device include organ perforation and mesh erosion. Because the mesh is designed to be a permanent implant, blood vessels and tissues grow around the device, making removal difficult if not impossible. Revision surgery, in which the mesh is removed in sections over the course of several surgeries, sometimes does not correct the complications caused by the device.
Why is transvaginal mesh a legal issue?
The development of transvaginal mesh stems from the use of standard surgical mesh. Surgical mesh had been a standard treatment for hernia repair since the 1950's, and surgeons began to use this mesh in the 1970's for the repair of pelvic muscle weakness. Surgeons cut the surgical mesh to a specific size and shape for each patient and implanted this modified device via abdominal surgery. In the 1990's, medical device manufacturers began to develop surgical mesh products specifically designed for gynecologic use, creating and marketing kits that included the mesh, special tools, and instructions for implanting the mesh. These kits promoted a new method for implanting the mesh trans-vaginally, which was quicker, simpler, less invasive than traditional abdominal surgery, and did not require the specialized training associated with abdominal surgery.
Unfortunately, the Food and Drug Administration (FDA) did not require the manufacturers of transvaginal mesh products to test these products via clinical trials before they entered into the market as a treatment option. Many of the products in use today are modeled after a product that was recalled in the late 1990's, further compounding the problem.
The legal issues of the use of transvaginal mesh stem from the lack of testing to assure the product would be safe for widespread use.
What happens when a medical device is found to be damaging?
Often, the problems that come associated with medical devices are the result of little to no testing on the part of the manufacturer, which is a result of a loophole in the certification process of the FDA. The FDA only requires that a medical device introduced onto the market be comparable to other devices already in use in the medical community. In the case of transvaginal mesh, the comparable device cited was the surgical mesh that had been in use since the 1950's.
As a governmental entity, the FDA can and does issue recalls for medical devices. These recalls are based upon reporting from manufacturers, the medical community, or the CDC, depending on the product in question. If a medical device is found to be defective, causing serious health issues or even death, the FDA can issue a recall of that device. Recalled medical devices can become part of both individual and class action lawsuits. However, despite the mounting evidence against transvaginal mesh as a dangerous and damaging medical device, the FDA has not recalled it. Instead, they have issued a Section 522 order, a postmarket surveillance which requires companies manufacturing transvaginal mesh to conduct studies that will provide data on the devices.
Who is liable for the problems caused by transvaginal mesh - a physician or a medical device manufacturer?
The difference between medical malpractice and products liability in the case of transvaginal mesh lies in the responsibility of the manufacturer of the device, not the surgeon who implanted the device, although there may be some residual legal responsibility borne by the physician. Medical malpractice is a legal field unto its own, and may or may not have bearing on a products liability case, depending on individual circumstances. An experienced attorney can help a client untangle the various legal issues involved in a transvaginal mesh case.
The news media and the legal system are filled with stories of women whose lives were jeopardized by the use of transvaginal mesh, and because a recall has not been issued by the FDA, the mesh is still being used by the medical community. This is a serious public health issue, and the outcome of the thousands of lawsuits currently in the nation's legal system will serve to protect others from falling victim to this damaging medical device. If you or someone you know has been affected by the use of transvaginal mesh, contacting an attorney experienced in pharmaceutical products liability is a first step in determining your rights.