January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.
The Food & Drug Administration (FDA) began Advisory Committee hearings yesterday to address concerns regarding vaginal placement of surgical mesh to treat pelvic organ prolapse and stress urinary incontinence. The Advisory Committee is being asked whether the manufacturer’s transvaginal mesh notification about risks and warnings are adequate. This same panel of physicians is being asked to determine whether the use of transvaginal mesh results in better outcomes compared to pelvic organ prolapse or stress urinary incontinence repair surgery not using the mesh. Therefore, the Advisory Committee will determine if there is adequate assurance of the safety of vaginally placed surgical mesh and whether the risk warnings should be changed.
Before the Advisory Committee started its hearing, the FDA issued an Executive Summary summarizing the Adverse Event Reports the FDA received from 2008-2010. The FDA reported that for transvaginal mesh, the top ten adverse events were erosion, pain, infection, bleeding, dyspareunia (painful sexual intercourse), organ perforation, urinary problems, neuro-musclar problems, vaginal scarring/shrinkage and prolapse recurrence. In fact, the FDA reported that some patients who received the transvaginal mesh experienced more than one of these complications. Therefore, the FDA staff recommended that transvaginal mesh be reclassified as high risk and be placed under more regulatory controls.
In hearings yesterday, the director of medical affairs for Ethicon, Piet Hinoul, responded to the FDA’s Executive Summary. Mr. Hinoul stated that transvaginal mesh is “not the optimal solution for everyone but it will be for some.” Mr. Hinoul further argued that the existing studies prove the transvaginal mesh is safe and effective. He stated that “serious adverse events that are mesh-specific are very low.”
Ginger Glaser, a senior director for Endo Pharmaceuticals, said in an interview at the hearing that the manufacturers would agreed on the need for label changes to warn consumers of the potential risks and more safety studies. However, Ms. Glaser stated that if transvaginal mesh is classified as a “high risk” the manufacturing companies would have a greater burden due to manufacturing procedure approval, plant inspections and longer review times.
The deputy director of the FDA Center for Devices and Radiological Health stated in a telephone interview that “The clinical effectiveness of surgical mesh for transvaginal repair of pelvic organ prolapse has not been demonstrated.” He expressed how proper studies needed to be performed to ensure effectiveness.
The Advisory Committee hearings are scheduled to continue today. However, it is not anticipated that the panel of physicians will take formal votes this week to determine whether transvaginal mesh remains on the market, has increased warnings, or will be otherwise subjected to greater FDA control.