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A new study indicates that the use of a vaginal sling to support the bladder in conjunction with surgery to repair pelvic organ prolapse may reduce a woman’s risk of urinary incontinence following the procedure. However, the findings also highlight some potentially serious side effects from the bladder sling and come amid mounting surgical mesh lawsuits filed by women who have experienced problems with the products.
In recent years, increasing concerns have emerged about complications with vaginal mesh and sling products used to repair pelvic organ prolapse (POP) and female stress urinary incontinence (SUI). The products have been linked to reports of severe pelvic pain, incontinence, infection and complications where the mesh may erode through the vagina after surgery.
Thousands of women throughout the United States are currently pursuing a lawsuit over vaginal mesh or a bladder sling, alleging that the manufacturers failed to adequately research the devices or warn about the risk of complications.
Earlier this year, the FDA ordered several medical device manufacturers to conduct additional studies on the use of vaginal slings and mesh products for repair of POP and SUI. The post-marketing studies were ordered after the agency received more than 1,500 adverse even reports between 2008 and 2010.
Use of Vaginal Sling During Pelvic Organ Prolapse Repair Surgery
In this new study, which was published last week in the New England Journal of Medicine, researchers examined the risk of incontinence developing after vaginal surgery to repair pelvic organ prolapse (POP), finding that doctors may be able to reduce the risk of that problem by implanting a vaginal sling during the procedure to support the bladder.
Researchers looked at data on 327 women who underwent vaginal prolapse surgery for treatment of pelvic organ prolapse (POP), none of which had experienced stress urinary incontinence (SUI) before undergoing the surgery. As part of the study, women where randomly assigned to either receive a bladder sling during the procedure or to receive a “sham” incision without inserting the sling.
According to the findings, about 50% of women who did not receive the vaginal sling during pelvic organ prolapse repair reported suffering signs of incontinence within about three months of the procedure. However, only 23.6% of women who received a sling along with the vaginal repair procedure reported signs of incontinence during the same period.
After a year, allowing for subsequent treatment of incontinence, about 43% of the women who did not receive a vaginal sling reported signs of incontinence, compared with 27.3% of women who did receive one to support the bladder following surgery.
The findings suggest that combining a surgical treatment for pelvic organ prolapse with the implantation of a bladder sling, despite the lack of any signs of incontinence before surgery, may significantly reduce the risk of the problems developing after surgery. However, the study did identify certain risks associated with the vaginal sling surgery, which may result in other severe problems.
Researchers found that women faced a 67% greater chance of a bladder perforation if they received the vaginal sling, a 3.1% greater chance of major bleeding complications and 3.7% increased risk of problems emptying their bladder after receiving the vaginal sling surgery. Those complications were not seen among women who received the pelvic organ prolapse repair without the use of bladder sling.
Lawsuits and Calls for Recall of Vaginal Mesh and Bladder Sling Products
Over the past year, there have been calls for manufacturers to recall vaginal mesh products used for repair of pelvic organ prolapse, suggesting that the benefits provided by the products do not outweigh the risk of complications.
In July 2011, the FDA issued a warning that indicated that they could not find any evidence that the use of a transvaginal mesh to repair pelvic organ prolapse provided any benefit over other means of treating the condition.
Amid the mounting litigation and the recently required FDA studies, Johnson & Johnson’s Ethicon subsidiary announced earlier this month that they were removing their Gynecare vaginal mesh from the market, including products used for pelvic organ prolapse repair, as well as slings used to support the bladder. The manufacturer has indicated that they plan to “cease commercializing” the products, and has asked the FDA to place a hold on any requirements that they complete the ordered studies.
In the federal court system, the vaginal mesh litigation has been consolidated into four different MDLs (multidistrict litigations), which are centralized before Chief District Judge Joseph R. Goodwin in the U.S. District Court for the Western District of Virginia.
According to court documents released this month, there are currently more than 253 Ethicon vaginal mesh lawsuits, 333 American Medical Systems (AMS) mesh lawsuits, 183 Boston Scientific mesh lawsuits and 411 lawsuits over vaginal mesh sold by C.R. Bard. In addition, product liability lawyers continue to review potential claims for women who allege that serious complications following surgery would have been prevented if the manufacturers had adequately researched the products and provided proper warnings.