The Food and Drug Administration employs a variety of approval guidelines to clear drugs, devices and other products made my pharmaceutical companies and manufacturers.
Several transvaginal mesh manufacturers have been implicated in countless lawsuits over recent years, and many have pushed back on court consolidations.
Used primarily to treat organ prolapse, transvaginal mesh is inserted into a woman’s body when pelvic organs begin to sink downward into the vagina.
The Ethicon Inc. division of Johnson & Johnson was ordered to pay $5.7 million over transvaginal mesh injuries caused by one of their devices just this month.
Transvaginal mesh has been under strict scrutiny from the Food and Drug Administration, healthcare providers and afflicted patients thanks to a growing number of lawsuits in the past few years.
Johnson & Johnson’s Ethicon Division, Boston Scientific Corp, C.R. Bard and four other transvaginal mesh makers are now facing one of the biggest U.S. mass torts in history, and U.S. District Judge Joseph Goodwin is urging them to resolve the more than 70,000 lawsuits filed against them.
On Nov. 4, Boston Scientific Corp began their first federal trials for transvaginal mesh claims.
Transvaginal mesh is used to treat pelvic organ prolapse and stress urinary incontinence, but these devices sometimes cause serious complications.
Many manufacturers of devices used to treat stress urinary incontinence and pelvic organ prolapse are facing transvaginal mesh lawsuits from women who were seriously injured after being treated with these products.
When women experience stress urinary incontinence or pelvic organ prolapse, they may be treated with transvaginal mesh, but this device can lead to complications like chronic pain, perforation, organ damage, scarring and other serious side effects.