July 26, 2011
FDA Investigating TVM: Reported complications involving transvaginal mesh prompt FDA to reconsider safety
According to an MSNBC article on mounting concerns about the safety of transvaginal mesh (TVM) devices, patient reports of adverse side effects and surgical complications have tripled since 2008. The Food and Drug Administration (FDA) plans to meet in September to address whether TVM products should undergo more thorough testing.
The report highlights the experience of Janet Holt, who underwent a bladder lift procedure involving a TVM implant and ultimately required seven additional corrective surgeries over a four year period.
Prescription drugs must undergo rigorous testing before being placed on the market. Only an estimated ten percent of devices, however, require such testing and are limited to those considered risky enough to require stricter parameters. Transvaginal mesh /sling products do not fall into this category.
Motley Rice medical device lawyers Jonathan Orent and Fidelma Fitzpatrick represent Holt and numerous other clients allegedly harmed by transvaginal mesh/sling products in hundreds of filed cases against large corporations that include Boston Scientific, American Medical Systems, Inc. (AMS), C.R. Bard, Inc., and Johnson & Johnson.
Read MSNBC's full article on potential transvaginal mesh complications.
Learn more about how Motley Rice device lawyers are fighting on behalf of patients who may have suffered injuries or complications related to defective medical devices.