Risks Outweigh Benefits of Pelvic Mesh and Sling Devices
Urinary Stress Incontinence ("USI") and Pelvic Organ Prolapse ("POP") are relatively common but treatable medical conditions. USI is the loss of bladder control which affects many older women and women following childbirth. POP is a weakening of the muscles and ligaments that support organs like the bladder and uterus and has the potential to be very serious. Traditionally, doctors treated these conditions without mesh in a procedure called an abdominal sacrocpopexy which uses the patient's own ligaments to support weakened muscles. More recently, an increasing number of gynecological and urological surgeons have been using vaginal mesh and sling devices. It was thought that transvagnial mesh would lead to better outcomes; however, a recent study concluded that not only was this traditional surgery just as effective as the mesh, but there were significantly more complications and side effects as a result of using mesh.
A recent article in the journal, Obstetrics & Gynecology, described a 15 percent adverse event rate of women in a clinical trial who received the mesh as completed to those who were assigned to receive the colpectomy. The majority of the side effects concerned "erosion" where the skin splits and the mesh protrudes, resulting in infections, pain, scarring and future surgery to remove the mesh. The study was halted mid-way because too many of the mesh patients were suffering from complications. The study concluded "At 3 months, there is a high vaginal mesh erosion rate (15.6%) with no overall objective and subjective cure rates. This study questions the value of additive synthetic poypopylene mesh of vaginal prolapsed repairs."
Prior to the study, the FDA had issued a 2008 "safety alert" to physicians that vaginal mesh had been associated with complications but that the problems were "rare". This was based upon more than one thousand adverse event reports sent to the FDA between 2005 and 2008. And in 2009, the FDA again issued a "safety alert" to warn of complications. Patients should be informed that mesh placement is permanent and advised of the potential for and nature of related complications, including erosion, infection and perforation.
In October 2010, lawsuits against the manufacturers of transvaginal mesh products were consolidated for case management purposes before Judge Carol Higbee in state court in New Jersey. These cases are known in New Jersey as In re J&J Litigation and In Re Bard Litigation. The products involved in those suits include the defective Gynecare Prolift, Bard Avaulta and Bard Pelvi mesh devices. The manufacturers of the Transvaginal Sling and Mesh products in the New Jersey litigation include Johnson & Johnson and C.R. Bard.
On September 11, 2011, an FDA Advisory Panel recommended that vaginal mesh products be reclassified to Class III devices and that more stringent pre-market testing be required prior to approval. Class III devices are required to undergo full pre-market approval, which includes safety testing. To date, most mesh products had been approved under a 510(k) review process, which only requires a showing that a devices is substantially similar to another device previously approved.
In the last ten years, the FDA has approved over 100 vaginal mesh devices without any preclinical testing. As a result, horrible complications associated with these devices have increased dramatically. In fact, in the last three years alone, almost 3,000 adverse events have been reported to the FDA. These complications include organ perforation, bleeding, urinary incontinence, infection, painful intercourse, erosion and the need for additional surgeries.
There are numerous manufacturers of these products in addition to Johnson & Johnson and C. R. Bard, including American Medical Systems, Caldera, Coloplast and Boston Scientific. American Medical Systems manufactures the following mesh/sling products: Apogee, Perigee, Mini-Arc Sling, Monarc Subfascial Hammock, Influence In-Fast, In-Fast Ultra, IntePro Y sling, Elevate with IntePro, Intexen, Bio-Arc and Sparc. Boston Scientific manufactures the following: Pinnacle, Advantage, obtryx, Lynx, Prefyx, Solyx and Posterior Uphold. Bard manufactures the following: Uretex, Pelvisoft, Avaulta, Pelvilace, Pelvicol, Align and Pelvitex. Johnson and Johnson manufactures Gynecare, Gynemesh and Prolene Mesh. Coloplast manufactures ARIS TOT and NovaSilk. Caldera Medical manufactures T-Sling and Desara.
Despite the high number of serious complications caused by these devices, the FDA still has not recalled them. If you or a loved one has suffered serious complications and/or additional surgery as a result of a transvaginal mesh or sling medical device, please contact Pogust Braslow & Millrood. Just fill out this form, click here to send us an email or call us at (610) 941-4204
|
