31 Jul FDA Decides Not to Ban Vaginal Mesh Implants despite Public Citizen’s Urgings
Despite consumer advocates’ strong urgings, the U.S. Food and Drug Administration (FDA) has decided NOT to ban vaginal mesh implants in the U.S. This decision, which regulators publicly announced on July 23, 2014, was a blow to consumer advocates at Public Citizen who had been pushing regulators to prohibit future sales of these dangerous medical devices in the U.S.
Background on Vaginal Mesh Problems and Complications
Vaginal mesh, which is also referred to as transvaginal mesh, has been surgically implanted in women since the 1990s in an effort to treat pelvic organ prolapse and/or stress urinary incontinence. Despite its efficacy for some women, the FDA has issued a series of warnings regarding these implants, including a particularly serious safety announcement in July 2011 that explained that severe vaginal mesh complications “are not rare.” In fact, in this announcement, regulators highlighted that fact that more than 1 in 10 women develop a severe complication within one year of having a vaginal mesh device implanted.
Serious complications associated with the implantation of vaginal mesh include (but are not limited to):
- Erosion of the mesh device through the vaginal lining
- Perforation of the blood vessels and organs surrounding the mesh
- Vaginal scarring
- Pelvic pain
- Pain during intercourse.
Though FDA Will Not Ban Vaginal Mesh, It Acknowledges Its Risks
Although regulators will not prohibit the sale or use of vaginal mesh in the U.S., regulators continue to express their concerns regarding the risks associated with these medical devices. In fact, in the recent announcement published by the FDA, Nancy K. Slade, the deputy director for the FDA’s Policy Center for Devices and Radiological Health, explained that:
[Regulators don’t] believe that a ban or recall of non-absorbable surgical mesh for transvaginal repair of POP [pelvic organ prolapse] is warranted at this time…[however, the FDA] agrees that the adverse events associated with the use of surgical mesh for transvaginal POP repair includes post-operative complications such as mesh exposure; mesh extrusions, vaginal scarring, shrinkage, and tightening; pelvic pain; infection [etc.].
Additionally, regulators have ordered various manufacturers of vaginal mesh to conduct postmarket studies regarding the safety, effectiveness and risks of these devices. While the results of these studies have yet to be produced, more than 16,000 injured women have already sought justice for their vaginal mesh injuries by filing lawsuits against the makers of their defective vaginal mesh devices.
Phoenix Product Liability Lawyers at the Law Office of Richard Langerman
If you have suffered a serious injury due to the use of any vaginal mesh implant, the Phoenix product liability lawyers at the Law Office of Richard Langerman are here for you and will fight to help you obtain the highest possible settlement for your injuries, damages and losses.
For more than 25 years, our attorneys have been representing clients and aggressively defending their rights both inside and outside of the courtroom against defense attorneys, corporate lawyers and insurance company agents alike. In addition to having extensive experience handling product liability cases, our attorneys are also skilled at overseeing motor vehicle accident cases, insurance bad faith cases and various other types of personal injury cases.
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