FDA Warnings Against TVM for Pelvic Organ Prolapse
Doctors can treat most pelvic organ prolapse (POP) cases without implanting transvaginal mesh (TVM). Moreover, doctors should share this information with patients, according to the Food and Drug Administration. The agency warned consumers and doctors against using transvaginal mesh. In fact, TVM may cause serious health issues and injuries, including mesh erosion, vaginal pain and infection.
The FDA first issued a formal warning in 2008 after it received many reports about transvaginal mesh-related injuries. By October 2011, the FDA had more than 1,000 adverse event reports about mesh devices. Again in 2011, the FDA issued a second warning regarding serious pelvic mesh complications.
“Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern,” the July 2011 warning stated. “The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008.”
Pelvic Organ Prolapse Complications Related to TVM
Mesh erosion, pain, infection, bleeding, organ perforation and urinary problems were the most frequent complications reported to the FDA from 2008-2010 among women using TVM to treat POP. However, some women reportedly suffered neuromuscular problems, vaginal scarring and shrinkage and emotional problems, the FDA reported. The most frequently reported adverse event is vaginal mesh erosion, which can require multiple repair surgeries. However, even multiple surgeries may not be able to resolve the complication, the FDA said.
Because of potential complications, the FDA determined using transgavinal mesh comes with health risks not present among traditional nonmesh surgery used to treat POP. Transvaginal mesh also has no additional benefits compared to traditional surgery without mesh to treat pelvic organ prolapse, the FDA said.
Doctors Must Inform Patients of Dangers
The FDA said physicians should know POP can be treated without using possibly dangerous transvaginal mesh devices. Physicians should inform patients there are nonsurgical options to treat POP. Doctors and patients should “choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical alternatives,” the federal agency said.
Transvaginal mesh puts patients at risk of requiring multiple revisions surgeries due to numerous likely complications, the FDA said.
After the FDA issued this warning in July 2011, some doctors significantly disagreed. Later that year, a group of pelvic surgeons emailed the FDA explaining why they disagreed with its conclusions regarding TVM. Dr. Miles Murphy, associate medical director at the Institute for Female Pelvic Medicine & Reconstructive Surgery and Director of the Division of Urogynecology at Abington Memorial Hospital, said transvaginal mesh could help some women and may be the best option for some patients, Commonhealth reported.
“I’m hoping that the information [in our letter] will allow us to continue doing a procedure that in the right hands can be very beneficial,” Murphy said, according to the source.
The Medical Field Divided on POP Treatments, TVM
Dr. Peter Rosenblatt, director of Urogynecology and Reconstructive Pelvic Surgery at Mt. Auburn Hospital in Cambridge, MA, also said he doesn’t consider some complications caused by transvaginal mesh “serious.” For instance, Rosenblatt said mesh erosion is “more of a nuisance” than a serious complication, Commonhealth reported.
However, thousands of women have filed lawsuits against pelvic mesh makers after experiencing severe pain and complications. These lawsuits are now pending in state and federal courts.
If you were injured due to complications involving TVM, you may qualify for a transvaginal mesh lawsuit. Complete a free case review form now to start your free consultation with an attorney in your area.