Transvaginal Mesh Sales Halted: Johnson & Johnson
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
Johnson & Johnson has kept plaintiff attorneys very busy in the last few years, and now they just got busier. Their controversial transvaginal mesh products have been pulled from the market. This mesh has resulted in many women experiencing excruciating symptoms, often permanent. Most shocking, many women received the mesh for relatively minor conditions, such as occasional urinary incontinence. Sadly, many other medical device companies jumped into the business without ever studying safe designs. Companies retrofitted hernia mesh materials and designs for support of the uterus, vagina, bladder, colon and other lower abdominal organs in women. Unfortunately, hernia mesh is relatively rigid and unforgiving, while female organs are often very flexible with natural movements. The mesh tears into these organs causing erosion, scarring and infections. Some of our clients report horror stories and, shockingly, their physicians seem to dismiss complaints.
The brands made by Johnson & Johnson's Ethicon division are: TVT Secur; Prosima Pelvic Floor Repair System, Prolift Pelvic Floor Repair System and the Proflit MTM Pelvic Floor Repair System. Thousands of suits are filed in state and federal courts, with our firm making a case-by-case decision as to what court offers our client the fairest venue. While the recall move is commendable, Johnson & Johnson can now discontinue safety and efficacy studies ordered by the FDA earlier this year. Another example of this was Bard/Davol recalling Kugel Composix hernia mesh sales which freed them from having to report to the FDA and subsequent adverse event reports. As vaginal mesh reports of failures flooded the FDA, the agency mandated manufacturers to do safety studies. News reports embarrassingly revealed that the FDA was not even aware of or monitoring some of the mesh models being marketed. Over the last few years, the FDA has, through its MedWatch department, issued piecemeal mesh alerts regarding severe side effects and the mesh's ineffectiveness for prolapses.