Limit Use of Transvaginal Mesh in POP Repair, Medical Groups Urge

Two prominent medical groups are recommending that doctors limit the use of transvaginal mesh products for pelvic organ prolapse (POP) surgery to high risk women for whom the risks do not outweigh the benefits. Citing safety concerns, the American College of Obstetricians and Gynecologists and (the College) the American Urogynecologic Society (AUGS) also called for the establishment of a national registry to track outcomes for all current and future patients who receive transvaginal mesh implants.

The two groups, which issued joint recommendations yesterday, are just the latest to raise concerns about the use of transvaginal mesh devices in POP surgery. This past July, the U.S. Food & Drug Administration (FDA) warned that between 2008 and 2010, it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, and pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.

In September, an FDA advisory panel backed a proposal by agency staff to reclassify transvaginal mesh as a Class III (high risk) medical device. Currently, the devices are classified as moderate risk (Class II), making them eligible for the 510(k) approval process, which does not require human trials before a device is brought to market.

In the joint statement issued yesterday, Cheryl B. Iglesia, MD, former chair of American College of Obstetricians and Gynecologists College’s Committee on Gynecologic Practice, warned that a “small but significant group” of women who received transvaginal mesh products for POP repair “experience permanent and life-altering problems, including pelvic pain and painful sexual intercourse because the mesh erodes through the vaginal wall.” The recommendations of The College and AUGS include the following:

• Continued audit and review of outcomes as well as the development of a surveillance registry for all current and future vaginal mesh implants;

• 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;

• Limiting use of POP vaginal mesh repair to high-risk women for whom the benefit may justify the risk;

• 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 groups’ recommendations only address the transvaginal placement of surgical mesh for POP repair, not procedures that are performed via an abdominal incision. POP occurs when the pelvic floor muscles that support the uterus, bladder, urethra, small intestine, rectum, and top of the vagina become weak due to tearing or stretching caused by child birth or other factors. While many women with POP experience no symptoms, others may suffer from pelvic pressure, lower back pain, urinary incontinence, sexual difficulties, or problems having a bowel movement. The rate of POP continues to grow, and it is estimated that 350,000 women undergo surgery for this condition in the U.S. each year.

This entry was posted in Defective Medical Devices, Transvaginal mesh. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.