Use Of Vaginal Sling During Surgery Linked To Increased Urethral Sling Complications
Bernstein Liebhard LLP, a New York law firm nationally recognized for its consumer protection and mass tort practices, reports on a June 21, 2012 study published in The New England Journal of Medicine, which found that though the insertion of a vaginal sling during surgery decreases the chances of postoperative urinary incontinence, it carries higher risks of urethral sling complications.*
The study analyzed data from 337 participants who underwent surgery to treat pelvic organ prolapse (“POP”) between May 2007 and October 2009. The women were randomly assigned either a vaginal sling or sham incisions. The study found:
- After three months, 23.6 percent of women with the sling had urinary incontinence, compared to 49.4 percent without a vaginal sling.
- After 12 months, 27.3 percent of patients with the sling suffered from urinary incontinence, compared to 43 percent of those without.
- Those implanted with the sling suffered complications. Nearly seven percent of the sling group suffered bladder perforation, versus none in the control group.
- 31 percent of women experienced urinary tract infections as a urethral sling complication, versus 18.3 percent in the non-sling group.
- Bleeding complications occurred in 3.1 percent of the sling group; incomplete bladder emptying occurred in 3.7 percent of the sling group. Neither occurred at all in the non-sling group.
Urethral Sling Complications Adds To Concerns About Vaginal Mesh Side Effects
“This study provides further evidence of what plaintiffs have been contending all along in the transvaginal mesh litigation, that this product is simply too dangerous and inappropriate for use in the pelvis,” said Bernstein Liebhard LLP partner Jeffrey S. Grand, who serves as co-liaison counsel in In re Pelvic Mesh/Gynecare Litigation, No. 6341-10 (N.J. Super Ct.) and In re Pelvic Mesh Litigation/Bard No. L-6339-10 (N.J. Super. Ct.), two consolidated actions of all vaginal mesh lawsuits filed in New Jersey state court. Mr. Grand also serves on the Plaintiffs’ Steering Committee in all four federal vaginal mesh MDLs, In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation (“MDL No. 2327”), In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (“MDL No. 2325”); In re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation (“MDL No. 2326”); and In re: C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation (“MDL No. 2187”), which are pending in the U.S. District Court for the Southern District of West Virginia before Judge Joseph R. Goodwin.
According to an accompany commentary to the study, vaginal mesh slings are different from other types of transvaginal mesh used for POP repair. The slings are small and shaped like straps, approximately 1 cm wide and 10 cm long, while vaginal mesh sheets can span up to 10 cm wide and 20 cm long. In September 2011, the U.S. Food and Drug Administration (“FDA”) convened a panel to evaluate the safety of vaginal mesh implants. Although the agency recommended post market studies for transvaginal mesh, they did not require such studies for midurethral slings. The latest study raises questions about the risks and benefits of vaginal mesh slings. The FDA noted that the vaginal sling provides an “anatomic” benefit, but may not result in better symptomatic results. Since the study was limited to a one year follow up, the long-term consequences of urethral sling complications are still unknown.
Lawsuits Mounting Concerning Vaginal Mesh Side Effects
Bernstein Liebhard LLP is currently filing lawsuits in both state and federal courts on behalf of individuals injured by vaginal mesh side effects. The lawsuits allege that the vaginal mesh manufacturers produced defective implants that caused vaginal mesh problems resulting in serious injuries.
Those who have suffered damages from vaginal mesh implants may be entitled to compensation for medical expenses, pain and suffering, lost wages and other injuries. Learn more by watching this vaginal mesh video, or by visiting our website.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past nine consecutive years. Only two firms in the country have been selected for the Hot List nine years in a row.
Bernstein Liebhard LLP 10 East 40th Street New York, New York 10016 (877) 779-1414
ATTORNEY ADVERTISING. © 2012 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414. The lawyer responsible for this advertisement in the State of Connecticut is Amy L. Abate. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Felecia L. Stern, Esq.
Bernstein Liebhard LLP