New Recommendations Issued for Use of Transvaginal Mesh
The American College of Obstetricians and Gynecologists and the American Urogynecologic Society (AUGS) have issued new health recommendations regarding the use of transvaginal mesh.
In a joint statement issued today, the two groups agreed that the use of transvaginal mesh to treat pelvic organ prolapse (POP) should be limited only to high-risk women who may receive a benefit that exceeds the risk. In addition to advising a limited use of surgical mesh, both groups are strongly encouraging federal health officials to create a national registry to track individuals who have or will receive a transvaginal mesh implant.
Pelvic organ prolapse is a weakening of the pelvic floor muscles, typically due to childbirth, menopause, hysterectomy among other conditions. Women with POP typically experience intense pelvic pressure, lower back pain, urinary incontinence, pain during sex and/or difficulty in having a bowel movement. Surgical mesh was first approved as a treatment for POP by the Food and Drug Administration in 2001. It’s estimated that approximately 350,000 women undergo transvaginal mesh surgery each year.
Numerous lawsuits have been filed on behalf of women who claim that the use of transvaginal mesh has resulted in serious side effects, including severe pelvic pain, infection, nerve damage, damage to blood vessels and significant internal scarring. The College and the AUGS opted to issue the new recommendations in light of the increasing number of lawsuits and the FDA’s July 2011 warning concerning the use of vaginal mesh.
Both groups also issued additional recommendations regarding the use and manufacture of the transvaginal mesh, including:
- Outcome reporting for prolapse surgical techniques clearly defining success, complications, and total reoperation rates;
- Surgeon training for vaginal mesh placement specific to each device, including surgical experience with reconstructive surgery and thorough understanding of pelvic anatomy;
- Rigorous comparative effectiveness trials of synthetic mesh and native tissue repair and long-term follow-up;
- Patient counseling that there are alternative native tissue repairs and that synthetic mesh is permanent, as well as discussion of the risks, benefits, and alternatives to the procedure;
- Adoption of new mesh products and devices only with clinical long-term data demonstrating equal or improved safety and efficacy compared with existing products and devices.
The College and the AUGS hope that physicians will proceed with caution in advising patients regarding the use of surgical mesh and that the new guidelines may reduce the number of women who experience adverse vaginal mesh side effects.
If you’ve experienced significant pain. infection, difficulty urinating or other painful conditions after receiving a transvaginal mesh implant, you have grounds for a personal injury lawsuit. The law firm of Nadrich & Cohen is currently investigating claims from women in all 50 states alleging serious injury after using vaginal mesh.
Call us today at to speak with a member of our transvaginal mesh legal team. We have the knowledge and experience you need to pursue a claim for damages stemming from your injuries. Contact us now for your free initial case evaluation. Remember, all cases are accepted on a contingency basis and there is never a fee unless we recover a judgment on your behalf. Don’t wait any longer to get the expert legal representation you need to win your transvaginal mesh injury lawsuit.