According to a recent Bloomberg report (Jan. 20, 2012), several House Democrats have written a letter to Republican members of the House Energy and Commerce Committee seeking a congressional hearing on the safety of vaginal mesh products like Gynecare vaginal mesh. Many women have experienced injuries from these devices and have filed vaginal mesh lawsuits in the hopes of receiving compensation, while some independent advocate organizations have called for a vaginal mesh recall.
U.S. Representative Henry Waxman of California is leading the hearing initiative, which seeks to determine whether or not the current FDA approval process for vaginal mesh and other similar medical devices is adequately protecting the safety of the public. Questions began when the number of women filing Gynecare vaginal mesh lawsuits increased, with women complaining of complications like mesh erosion, infections, bleeding, urinary problems, and recurring pain.
Are Gynecare Vaginal Mesh and Other Mesh Products Safe?
Vaginal mesh devices are used to repair conditions like pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Many women 40 and older experience these disorders, in which the pelvic muscles and tissues become too weakened and stretched to keep organs like the bladder, bowel, and uterus in place. Surgery with vaginal mesh was intended to help replace and support the organs in their proper positions.
A Vaginal Mesh Lawsuit Likely to Point Out FDA Warnings
Congress is concerned about the current FDA approval process called the 510(k), which requires no clinical trials on a new device”only that it show itself to be substantially similar to another device already on the market. In July 2011, the Institute of Medicine found that the 510(k) process was flawed and advised the FDA to develop a new one. Gynecare vaginal mesh and other mesh products were approved through this flawed process and have now been linked to serious complications.
On July 13, 2011, the FDA released an updated safety communication warning physicians that complications with vaginal mesh were not rare, and that there was no evidence that surgical repair of POP with vaginal mesh was superior to traditional repair without it. More recently, the FDA requested that Johnson & Johnson (makers of Gynecare vaginal mesh) and 32 other manufacturers conduct three years of trials on the safety and effectiveness of their vaginal mesh products.
Public Citizen Calls for Vaginal Mesh Recall
Meanwhile, in the wake of reports of serious Gynecare vaginal mesh complications, some organizations have come forward seeking a vaginal mesh recall. Public Citizen, for example, sent a petition to the FDA in August 2011 stating that treatment for POP needlessly exposes patients to serious, life-altering complications. Public Citizen petitioned for a vaginal mesh recall of all currently available non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of pelvic organ prolapse (POP)¦.
Congress Considering Overhaul of 510(k)
House Democrats seek the Congressional hearings now because they are considering changes to the FDA’s 510(k) approval process. They believe the hearings are necessary to gather more information on how the safety of these devices is measured, how the companies are marketing products such as Gynecare vaginal mesh, and whether these marketing tactics present a potential risk to the public. They have until October to reauthorize a law that funds the FDA’s review of new products.
You May Qualify for a Vaginal Mesh Lawsuit
If you or a loved one has been injured by Gynecare vaginal mesh or another vaginal mesh product, you may be eligible for a vaginal mesh lawsuit. Contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.
