In addition to investigating and pursuing claims involving defective metal-on-metal artificial hip implants, SUGARMAN has formed a team, led by principals Marianne LeBlanc and David McCormack, to represent women who have been injured as a result of defective transvaginal mesh used to treat pelvic organ prolapse and/or stress urinary incontinence. These transvaginal mesh products are increasingly being recalled or investigated by the Federal Drug Administration (FDA) due to the serious and long-term health risks that the implanted mesh can cause to women.
Surgical mesh is a medical device which has been used for more than three decades for hernia repair. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In most transvaginal mesh products, the manufacturer typically uses polypropylene, a synthetic plastic or polymer, to make the mesh. In 1996, the FDA cleared the first transvaginal mesh product for treatment of stress urinary incontinence, and in 2001 the agency cleared the first transvaginal mesh device for treatment of pelvic organ prolapse. Pelvic organ prolapse (displacement or slippage of pelvic organs through the vagina or rectum) and stress urinary incontinence (involuntary leakage of urine) can occur in women who have given birth. These are two fairly common medical conditions that such women can develop as they age.
By 2010, the FDA had cleared 168 transvaginal mesh devices under the FDA’s controversial fast-track 510(k) clearance process. The 510(k) process allows for FDA approval of a medical device without substantive studies if the device is “substantially equivalent” to another device already on the market (such devices are known as “predicate devices”).
While there are a number of companies that manufactured transvaginal mesh devices, Johnson & Johnson/Ethicon, Bard, American Medical Systems (AMS) and Boston Scientific manufactured the mesh products most commonly used by physicians to repair pelvic organ prolapse and stress urinary incontinence.
The Defective Nature of Transvaginal Mesh
On October 20, 2008, the FDA issued a public health notification to warn doctors and patients of serious, yet what it termed to be “rare,” complications associated with transvaginal mesh products after the FDA received over 1,000 reports of serious complications. The FDA noted reports of transvaginal mesh eroding through the pelvic anatomy, recurrence of prolapse and/or incontinence, and scarring and erosion leading to a “significant decrease in patient quality of life.” The FDA requested that patients and medical providers provide additional reports to the FDA so that the FDA could continue to evaluate the safety of transvaginal mesh products.
On July 13, 2011, the FDA did an about-face and warned of a rise in “serious complications” associated with surgical mesh for transvaginal repair. The FDA now stated that the serious complications were not rare and that use of transvaginal mesh for pelvic organ prolapse may expose patients to a greater risk than traditional surgical methods that did not include the placement of a medical device. The FDA also outlined additional complications that it had learned of involving transvaginal mesh devices and stressed that the adverse patient results were not linked to the products of a particular manufacturer – indicating that the medical problems that transvaginal mesh can cause are inherent to the product itself rather than the design used by a particular manufacturer.
The dangers of transvaginal mesh and the 510(k) process is illustrated in the predicate devices that manufacturers of the mesh devices claimed were “substantially equivalent” to their own in order to get 510(k) approval from the FDA. One of the predicate devices that two of the leading manufacturers of transvaginal mesh (Boston Scientific and Johnson & Johnson) identified in their initial applications for transvaginal mesh products was the ProteGen Sling manufactured by Boston Scientific, a corporation based in Massachusetts. Other transvaginal mesh manufacturers then used these early Boston Scientific and Johnson & Johnson mesh products as their own predicate devices. These early Boston Scientific and Johnson & Johnson mesh products serve as the predicate devices for the majority of transvaginal mesh products that were marketed to doctors and implanted in women.
The alarming problem is that Boston Scientific was forced to recall the ProteGen Sling in 1999 because of an unusually high number of complications associated with the device, including vaginal bleeding and erosion of the vaginal wall. The FDA went so far as to state that it “considers [ProteGen Sling] devices to be adulterated and misbranded.” Using the transitive property (if A = B and B = C, then A = C), the majority of transvaginal mesh products implanted in women claim to be “substantially equivalent” to the ProteGen Sling: a product that was so dangerous it was recalled over 13 years ago. In essence, a high number of transvaginal mesh products were based on a product known and acknowledged to be dangerous and defective.
Injuries Caused by Transvaginal Mesh
For women who have complications arising from the implantation of transvaginal mesh, the affect on their daily lives can be devastating. Most commonly, the rough edges of the transvaginal mesh erode through the lining of the vagina and into nearby organs, causing extreme pain and impacting the woman’s ability to urinate and have sexual intercourse. Thousands of women treated with these devices have experienced disabling injuries including:
Many women require surgery to attempt to remove portions of the transvaginal mesh from their bodies. Complicating these surgeries is that the mesh can adhere to a woman’s body, making an attempt to remove it extremely painful if not impossible.
If you believe you have suffered injury as a result of the implantation of transvaginal mesh, you should see your doctor as soon as possible for treatment and to inquire as to which mesh product was implanted.
SUGARMAN has formed a team of dedicated personal injury attorneys, led by principals Marianne LeBlanc and David McCormack, who represent patients with defective transvaginal mesh implants, with claims pending in both Massachusetts and Federal Court Multi-District Litigation (MDL). Please call one of our personal injury lawyers today to discuss your right to recover if you have complications arising from the use of transvaginal mesh to treat pelvic organ prolapse and/or stress urinary incontinence.