Problems instead of benefits may be experienced by women who have had transvaginal mesh surgery to treat pelvic organ prolapse (POP). Nearly 300,000 women underwent surgical mesh procedure for POP and 260,000 for SUI in the year 2010. The US Food and Drug Administration (FDA) issued an advisory on serious complications attributed to the use of surgical mesh products. Furthermore, FDA suggested that more studies be done and that patients, as well as surgeons, will take into consideration other treatment options available.
According to the FDA more than 100, 000 women a year are treated with surgical mesh device even if the condition may be treated successfully with a non-mesh device. Data received by the FDA in 2008 to 2010 shows that 1,503 adverse event reports linked with surgical mesh use for POP repair and its five times as many in year 2005 to 2007. It also received three reports of deaths that were attributed to the mesh placement surgery.
Nearly 10 percent of women who have had transvaginal mesh implant suffer from mesh erosion within 12 months of surgery, according to recent studies. Majority of the women who have had transvaginal mesh surgery require additional surgeries to remove the mesh implanted. There is a tendency that the mesh will get tangled with scar tissues making it impossible for surgery. According to FDA medical officer Dr. Jill Brown, “For women with unresolved pain from mesh that can’t be removed, their options can be limited.”
Aside from mesh erosion, other complications were reported to the FDA associated with the use of surgical mesh products. Complications like pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems were also observed. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Complications such as these require medical or surgical intervention and hospitalization.
Moreover, the FDA found out that there is no proof that would establish the clinical effectiveness of mesh over non-mesh products. It stressed that mesh use to treat POP introduces more risks not present in non-mesh POP repair. According to Dr. William Maisel the FDA’s deputy director of the Center for Devices and Radiological Health, “The evidence we reviewed calls into question the clinical benefit of mesh, and it certainly shouldn’t be used routinely for all transvaginal prolapse repairs.” In line with this reasoning, many women are now filing mesh lawsuit against the providers. Most women felt disadvantaged rather than good. Probably they will experience more problems than benefits as a result of the treatment.
URL References:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
http://www.boston.com/Boston/dailydose/2011/07/fda-warns-against-surgical-mesh-repair-pelvic-problems/Yf5Ukjj5JiACnJ515sPPVL/index.html