Vaginal Mesh Draws Increased Scrutiny
Posted on October 3rd, 2019 by Zane Cagle
Women continue to come forward, alleging the vaginal mesh they had inserted to keep pelvic organs in place resulted in severe damages. More than 600 women have filed suit thus far, alleging the vaginal mesh caused such damages as severe pain (in some cases comparable to childbirth), infection, vaginal discharge, vaginal scarring, inflammation, erosion of the vaginal tissue, mesh protruding from the vagina, pain during sexual intercourse, and mesh shrinkage or disintegration. These women allege that drug manufacturers began marketing the product without proper testing.
The FDA issued a warning that the risks of using mesh in transvaginal procedures may outweigh the benefits. A panel recently agreed with the FDA’s recommendation that vaginal mesh is reclassified from moderate risk to high risk of hurting patients if it fails. The FDA has also called for more studies regarding the safety of this product. It first issued a safety communication about this product in 2008, as women began to complain about adverse effects from this surgery. Since that time, more than 1,500 women have come forward complaining about complications.
According to Businessweek, medical devices, unlike drugs are able to skip the rigorous testing and can go straight to market. This is accomplished by using a truncated approval process known as 510(k). With this, if a manufacturer can prove a device is “substantially equivalent” to a device currently on the market, thus allowing “clearance” by the Food and Drug Administration to be sold in the United States. One of the main offenders in terms of complications has been a product available since 2002. Devices such as these have been used to treat hernias and urinary incontinence for many years, but use for pelvic organ prolapse is still relatively new according to ABC News
The drug companies, for their part, claim that the risk of serious complications from this surgery is very low. These manufacturers say that while vaginal mesh and the accompanying surgery are not for every woman, it is still an appropriate procedure for some. They contend that more data is needed before issuing a full recall, claiming that, while some women have experienced severe complications, it is unknown exactly how large of a percentage these women represent. Until such data has been assembled, they argue that a full recall is inappropriate. Vaginal mesh treatments are a permanent procedure, and complications arising from it can cause life-long problems.
If you or a loved one has had this surgery and is now experiencing adverse reactions to it, you will need an experienced, capable attorney to represent your needs. You may have what is called a product liability case. If you live anywhere in the Missouri, Illinois, or Kentucky areas, Zane T. Cagle may be able to assist you. If you have questioned whether the mesh used in your surgery is one of the manufacturers that has problems, it is a good idea to contact an attorney to get those answers. Contact Zane T. Cagle of The Cagle Law Firm today to discuss your legal options at (314) 276-1681.