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Free & Goss Attorneys

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On September 8-9, the FDA’s Obstetrics & Gynecology Devices Panel will meet to address concerns related to the safety and efficacy of transvaginal mesh.  Today, the panel released both discussion questions and the agenda for the conference, shedding light on FDA concerns, as well as potential future directions the agency may take.

The FDA has broken the discussion into two major divisions: vaginal placement of surgical mesh for pelvic organ prolapse (POP), and abdominal placement of the device.  With regards to vaginal placement, the FDA appears ready to reclassify the device from class II to class III, placing the device in the most tightly regulated classification, ending the ability for future transvaginal mesh devices to gain FDA clearance via the traditional 510(k) ‘substantial similarity’ process.  Instead, as a class III device, new transvaginal mesh products would be required to submit to the premarket approval (PMA) process, which in turn necessitates safety and effectiveness testing prior to FDA approval.

The FDA is also asking physicians and other concerned parties whether the list of potential risks should be expanded.  Currently, the FDA has identified the following risks via literature review and adverse event reports submitted to the MAUDE database.  These include:

Peri-Operative Risks

  • Organ perforation
  • Bleeding (including hemorrhage/hematoma)

Long Term Risks

  • Vaginal Mesh Exposure.  Clinical sequelae include pelvic pain, infection, dyspareunia (painful sex for patient or partner), vaginal bleeding, vaginal discharge, and the need for additional corrective surgeries.
  • Mesh erosion into the bladder or rectum.  Clinical sequelae include pelvic pain, infection, dyspareunia, fistula formation and the need for additional corrective surgeries (possibly including suprapubic catheter, diverting colostomy).
  • Other risks that can occur without mesh erosion.  These risks include pelvic pain, infection, dyspareunia, urinary problems, vaginal scarring/shrinkage, recurrent prolapse, neuro-muscular problems.

The FDA is also looking for additional information to support or refute its conclusion that scientific evidence does not demonstrate that vaginal mesh used for POP repair provides any clinical benefit compared to surgical repair of POP without mesh.  On this issue, they have asked for further input on such issues as whether the pelvic compartment for repair alters the safety or effectiveness of the device (e.g. anterior, posterior), whether the type of mesh used affects outcome (e.g. synthetic vs biologically derived grafts), and whether certain sub-populations would benefit from the mesh.

Finally, the FDA is asking respondents to answer whether clinical studies should be performed, either prior to approval, or in the context of postmarketing surveillance.  In addition, there are questions regarding how these studies should be conducted, with an emphasis on study design and the role and make-up of control groups.

The FDA does not seem as concerned with abdominal placement of these devices, stating their belief that abdominal placement of surgical mesh for POP repair is a well-established clinical practice.  On this subject, the FDA is asking concerned parties to state whether they agree with this assertion, and if not, whether premarket clinical data should be required and how it should be reported.  As with vaginal placement, they are also asking whether postmarketing surveillance should be required, and if so, how these clinical studies should be conducted, and which outcome measures and controls should be selected.

We will continue to monitor the FDA’s progress as they examine the current transvaginal mesh regulatory environment, and will report any major developments as they appear.