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Women who receive vaginal mesh made of synthetic materials implanted to treat pelvic organ prolapse (POP) fare no better than women who have the problem addressed using native tissue, and 10% of them can expect to experience painful complications from the vaginal mesh, such as erosion of the mesh into the vagina, according to the findings of two new studies.
In one study, revealed this week at the annual meeting of the Society of Gynecologic Surgeons, researchers indicate that cure rates and patient satisfaction were the same whether a woman used a transvaginal surgical for treatment of pelvic organ prolapse, or if the problems were resolved by a procedure using her own tissues. However, women who were implanted with a vaginal mesh suffered more complications.
Another study published this week in the Journal of the American Medical Association (JAMA) found that about one out of every ten women who received a vaginal mesh experience erosion, and many eventually suffer stress urinary incontinence in later years.
Researchers at the conference conducted a three-year follow up on 65 women, but women in the clinical trial suffered so many vaginal mesh exposures, in which the mesh erodes its way into the vagina, that the researchers cancelled further enrollment in the program. According to the researchers, 15.6% of women with vaginal mesh experienced mesh erosion.
No differences were noted in whether the procedures improved their ways of life, findings which echo concerns by the FDA, which has indicated that the agency has been unable to find evidence of any benefit in using vaginal mesh for pelvic organ prolapse.
In the JAMA study, researchers from the University of Utah School of Medicine collected data on 215 women over seven years who had various treatments for POP. They found little difference in the risk of anatomic and symptomatic failure and the onset of stress urinary incontinence between women who received a transvaginal mesh and those who did not. They did find that women who received the mesh had a 10.5% probability of mesh erosion after seven years.
The researchers concluded that the risk of mesh erosion should be calculated into healthcare professionals’ recommendations on how a woman should address POP problems.
In July 2011, the FDA issued a warning after receiving at least 2,874 reports of problems with vaginal mesh products between January 2008 and December 2010. After a review of all available data, the FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse.
In early 2012, the FDA sent a letter to several manufacturers of these products, ordering that they conduct additional studies and trials to evaluate the safety of transvaginal mesh products, and establish whether they pose an unreasonable risk of injury for women.
Thousands of women throughout the U.S. are currently pursuing vaginal mesh lawsuits against manufacturers of the medical devices, alleging that the transvaginal surgical mesh products are dangerous and defectively designed, carrying a risk of severe and debilitating health problems. The lawsuits have been brought by women who allege that they have experienced mesh erosion, damage to internal organs, infections and other side effects.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) has established separate consolidated proceedings in the federal court system for cases involving different manufacturers, with Multidistrict Litigations (MDLs) centralized in the U.S. District Court for the Southern District of West Virginia for all Bard Avaulta mesh lawsuits, American Medical Systems (AMS) vaginal mesh lawsuits, Boston Scientific pelvic mesh lawsuits, Ethicon Gynecare mesh lawsuits and Coloplast sling lawsuits.
Several cases pending in state courts throughout the country have already gone to trial, with a California court awarding $5.5 million in damages to a woman who experienced complications with a Bard Avaulta mesh in July 2012, and a New Jersey state court jury awarded $11.1 million in damages in February, including both compensatory and punitive damages for problems with Ethicon’s Gynecare Prolift mesh.