FDA Revises Requirements for Transvaginal Devices


Have you had the condition of pelvic organ prolapse (POP) repaired via a surgical mesh product?  If the answer is yes, you should be aware that the U.S. Food and Drug Administration (FDA) has made revisions to the data requirements regarding these devices after receiving thousands and thousands of reports of problem complications and consequences from their use. 

Pelvic organ prolapse is a condition in which pelvic floor muscles/tissue are stretched out, ripped, or weakened to the point that it cannot provide the support to the pelvic organs that normally prevents prolapse of those organs into the vagina.  The surgical mesh used to fix this problem was originally utilized to fix abdominal hernias, but the use for POP became common in the 1970s.  Problems that can occur include heavy bleeding, urinary issues, infection, nerve damage, and even the perforation of organs, which paves the way for a lot of pain and complications. 

Around one hundred thousand lawsuits have resulted from the dangerous surgical mesh complications because if it were not for wrong design and the use of cheap materials, many complications and health issues could have been prevented.  Companies who have made the surgical mesh devices include Boston Scientific Corp., Johnson & Johnson’s Ethicon, and C. R. Bard.  The FDA ordered the reclassification of the devices from moderate-risk class II devices to high-risk class III devices, as well as other written requirements.   

If you or a loved one has suffered the harmful effects of a surgical mesh device used for POP, do not hesitate to contact Inserra & Kelley Law Offices as you may be entitled to compensation for your injuries.