Saturday, November 24, 2012

Effectiveness of the FDA’s Warnings on Urogynecologic Mesh

This article will discuss the effectiveness of warnings issued by the FDA regarding the surgical use of urogynecologic mesh. Since the FDA first sent out a Public Safety Notification regarding mesh used in transvaginal pelvic organ prolapse surgery, they have been trying to get the word out to consumers and physicians about the potential risks involved. While there are over 100 mesh kits and mesh devices which have been FDA approved, only about twenty of those are currently manufactured and used in the United States. The article An Appraisal of the Food and Drug Administration Warning on Urogynecologic Surgical Mesh, published in Current Urology Reports (2012, 13:231-239) details the FDA’s journey from mesh approval for transvaginal POP surgery to their most recent update regarding mesh use in the Safety Notification Update sent out in 2011.

Reporting on Transvaginal Surgical Mesh Used in POP Repair

The FDA as well as other groups have stressed the fact that the outcomes for surgical procedures using mesh kits demands the surgeon have specialized training which will allow them to “recognize and manage the complications of surgical mesh implants.” The FDA is also considering changing the status of the mesh devices from a status II to a status III—those devices and drugs with the highest risk to consumers. As far as database reporting is concerned, the Center for Devices and Radiologic Health – a subsidiary of the FDA-both approves and collects data on the safety and efficacy of medical devices in the U.S. The FDA’s current adverse event reporting program, Medwatch, gathers information from physicians, hospitals and consumers on medical devices and drugs and compiles a database.

Should there be a death or serious injury which can be tied to a specific medical device or drug, that death or injury requires reporting to the FDA and the device or drug manufacturer. The current databases do have certain limitations. According to the Current Urology Reports article the surgeon who performs a woman’s transvaginal POP surgery is unlikely to be the follow-up physician should complications arise. In fact, most patient complications are seen in referral centers. Surgeons also rarely receive feedback following their surgical procedures therefore they can find it difficult to improve their surgical techniques.

Successful Treatment Can Have Many Definitions

It is very difficult to definitively define a “successful” transvaginal pelvic organ prolapse surgery for a variety of reasons. Pelvic organ prolapse symptoms vary widely from woman to woman, the degree of prolapse (as determined by a physician) may not correspond with reported symptoms and the degree of those symptoms, there are many different surgical techniques used in transvaginal pelvic organ prolapse surgery and the data regarding POP surgery is very diverse. One study sought to compare quality of life between those patients whose surgeon deemed their surgical outcome an “anatomical success” with patients who experience subsequent prolapse and found no significant differences. It is hoped that long-term studies will contribute to the understanding of early failures and complications associated with transvaginal POP surgeries using a mesh device.

Risk Factors Involved

Current Urology Reports lists the risk factors for mesh complications which include a hysterectomy performed at the same time as the POP repair, a “T” shaped vaginal incision, the surgeon’s level of expertise in performing the surgery, the age and health of the patient and patient history of tobacco use or diabetes. The FDA strongly recommends that all patients be provided with a written copy of the potential risks involved with transvaginal POP surgery using a mesh device. All in all, it appears the FDA’s warnings regarding urogynecologic mesh have been heard: On October 16, 2012, Drugwatch headlines stated: “Following FDA Report, Specialists Decrease Use of Transvaginal Mesh.” This article discussed the effectiveness of prior FDA reports and warnings regarding gynecologic mesh.

Author: Sullo & Sullo Attorneys

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