The Vaginal Mesh Controversy Continues
In early March 2015, a California jury ordered Johnson and Johnson’s Ethicon division to pay $5.7 million in the first trial due to injuries that have been attributable to the TVT Abbrevo mesh product. This settlement included $700,000 for compensatory damages for complication with the TVT Abbrevo mesh and an additional $5 million in punitive damages. This was a result of the jury deciding that Ethicon conducted business with malice towards patients, and that the company knew that the product caused severe complications but failed to warn physicians.
This transvaginal mesh is just one of the products that are presently the subject of numerous lawsuits. For those fans of late night television, not a night goes by without seeing and advertisement from one of the law firms aggressively seeking these claims. There are presently over 70,00 lawsuits pending against Ethicon and other manufactures of vaginal mesh products. Some of these companies include Boston Scientific, Bard, Coloplast, Cook Medical and American Medical Systems. AMS has already settled the majority of claims involving their products, paying about $1.6 billion to settle over 20,000 claims.
What is unique about this recent lawsuit, it that it’s for a product used for stress incontinence, and not pelvic prolapse. The focus of the majority of lawsuits filed have been for transvaginal mesh providing support for the base of the bladder after prolapse. These include patients that are mananging repaired cystoceles, which is a bulge of the bladder into or out of the vagina.
As a result of increased reports of complications related to vaginal mesh, the FDA issued a warning on July 13, 2011. There was an initial warning on October 20, 2008 that discussed both potential complications that were associated with the transvaginal placement of surgical mesh in the repair of pelvic organ prolapse and stress urinary incontinence. However, this newer warning was an update that more specifically addressed the issues that arise in patients treated with vaginal mesh for pelvic organ prolapse (POP). This updated analysis identified the placement of mesh for transvaginal repair of POP as an area of continued serious concern, excluding stress incontinence.
The most common complications that were seen include mesh erosion through the vagina, pain, infection, bleeding, painful intercourse, organ perforation and other urinary problems. Vaginal scarring has also been reported. ** Is Pelvic Mesh Safe?**
Many pelvic surgeons still successfully perform repair pelvic organ prolapse repair with mesh, however others do not use mesh and have relied on either using the patients’ native tissue, or perhaps biologic materials other than mesh. Simple stress incontinence without pelvic organ prolapse is still ideally treated with the use of transvaginal mesh. But agreement has not yet been reached if the complications are related to the mesh itself, or perhaps inexperience of some surgeons performing these procedures.
If you are suffering from pelvic organ prolapse and your surgeon recommends the use of mesh, be sure to discuss the experience of that doctor with mesh procedures. Preoperative usage of vaginal estrogen creams may help decrease the rate of complication, so be sure to discus that with oyour doctor as well. Additionally, be certain to discuss the potential complication that may occur with mesh. For pelvic organ prolapse, discussion should be undertaken to compare the success of mesh repairs with other products that are used to treat POP.
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Jay Motola, MD, is a board-certified urologist and attending physician, Department of Urology, Mount Sinai West, and Assistant Professor of Urology, Icahn School of Medicine at Mount Sinai. Dr. Motola is a summa cum laude, Phi Beta Kappa graduate of Boston University, and earned his medical degree at the State University of New York at Stony Brook.