April 24, 2012 ~ Even though the number of lawsuits against synthetic mesh manufacturers is growing by the day, surgical mesh products are expected to surge in sales in 2012, according to the Millennium Research Group (MRG). The group interviewed 181 U.S. surgeons (gynecologists, urologists and urogynecologists) in November and December of last year. Among them 130 used synthetic mesh in their practice and 51 used no mesh.
Millennium reports the market for mesh will grow by two percent for pelvic floor repair (transvaginal mesh) and for sacral colpopexy/hysteropexy procedures.
MRG generally delivery a pretty rosy picture about medical devices in general. Is the research group delivering the news that the intended audience would like to hear? (see their website)
Synthetic mesh is used to hold up descending organs in women (pelvic organ prolapse, POP) and to treat stress urinary incontinence (SUI). It is still being used by the medical establishment despite the many complications and despite two Food and Drug Administration (FDA) warnings. The second FDA Safety Notification issued in July 2011 (here) said complications associated with surgical mesh for transvaginal repair of POP are not rare, a change from the October 2008 notification.
Complications can lead to the mesh eroding and migrating injuring other organs, infection, nerve injuries, hemorrhage, urethral obstruction, extrusion, vaginal scarring and shrinkage as well as emotion problems among other complications. Multiple corrective surgeries are often required.
And the FDA suggested “that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.”
In January 2012, the FDA said it is considering a recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified as high risk.
Despite the dire reports, Drugwatch (here) quotes MRG analyst Sohaib Perwaiz who said, “Despite the recent controversy, and the fact that a large portion of physicians have reported increased patient concern about the safety and efficacy of urogynecologic transvaginal mesh and related procedures, many survey respondents [physicians] find that surgical mesh products have distinct benefits in treating pelvic organ prolapse (POP) and stress urinary incontinence (SUI).”
Here is the report which was released in December 2011. #