The Phillips Law Firm, a leading law firm representing plaintiffs in defective medical device lawsuits, is pleased to announce that British medical device regulators are taking action to reduce vaginal mesh side effects, according to the
Department of Health Media Centre. Vaginal mesh products are used in surgeries for pelvic organ prolapse and urinary incontinence. Some women who have undergone these surgeries have reported serious side effects, including pain, infection, mesh erosion, urinary problems and pain during sex, according to an FDA health notification. The Department of Health announced in its press release that it would be working alongside clinical groups and the Medicines and Healthcare products Regulatory Agency in an effort to reduce these side effects by helping surgeons and patients understand the risks and make informed decisions.
Vaginal mesh products are implanted inside the body during surgery to correct the weakening of tissues in the pelvic area due to age and childbirth. This weakening can lead to urine leaks during physical activity or even cause the organs to slip out of place (pelvic organ prolapse). The U.S. Food and Drug Administration estimates* that up to 50 percent of women may experience it in their lifetime, with 2 percent developing symptoms.
Evidence has been building since at least 2005 that vaginal mesh implants have serious side effects. Between 2005 and the end of 2010, the FDA received thousands of reports of adverse effects, leading to a 2011 announcement that vaginal mesh side effects associated with POP repair are “not rare.”* Reported problems included infection, severe pain (including pain during intercourse), perforation of the organs, urinary problems and a recurrence of the organ prolapse the surgery was supposed to fix. To make matters worse, the FDA said in a safety communication that relief often requires more surgery or hospitalization—although the agency found that even multiple surgeries don’t always solve the problem.
Reports of vaginal mesh side effects have led UK’s Department of Health to announce new guidance and support to reduce serious side effects from the use of vaginal mesh products. In the United States, the FDA has not banned the devices, but it issued a strong warning in 2011 after it found that it was “not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”* An FDA advisory panel** has since recommended that the devices be reclassified to require rigorous clinical studies before approval.
Currently, thousands of state and federal lawsuits*** are pending against vaginal mesh manufacturers, alleging that they failed to warn patients about the risks of pain and other serious side effects from vaginal mesh implants. Five federal multidistrict litigation (MDLs) have been established; cases have been consolidated in West Virginia (MDLs no. 2187, 2325, 2326 and 2327) and Georgia (MDL no. 2004).
About Phillips Law Firm
Based in the Seattle area, the Phillips Law Firm represents patients across the United States who have suffered injuries and reduced quality of life from a transvaginal mesh implant. Our attorneys have extensive experience helping ordinary people seek fair financial compensation—for their medical costs, pain and suffering and more. For a free case evaluation and to learn more about your rights, visit
http://www.justiceforyou.com/defective-drug/transvaginal-mesh.php.
*fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm
**acog.org/About_ACOG/Announcements/FDA_Announces_New_Regulatory_Action_on_Urogynecologic_Surgical_Mesh
*** jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets-By-District-January-2013.pdf
