If you had a vaginal or pelvic mesh (TVM) implant, also known as a pelvic mesh implant or bladder sling, and are suffering from painful, serious side effects after one or more revision surgeries, you are not alone. Complications involving transvaginal mesh devices have been reported in tens of thousands of women in relation to nine different transvaginal mesh manufacturers, including American Medical Systems (AMS), Boston Scientific, C.R. Bard, Inc., Covidien and Johnson & Johnson. Our experienced Pennsylvania injury attorneys are currently investigating the potential for transvaginal mesh lawsuits.
Vaginal mesh is a surgical netting implant used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI, involuntary loss of urine) in women. In these procedures, doctors surgically place the mesh through the vagina or the abdomen. Inserting the mesh through the vagina is quicker, easier and less invasive. The design and manufacturer-recommended implantation technique of some of these transvaginal mesh products contributed to problems such as infection, erosion of the vaginal tissues and organ perforation.
Most women who receive vaginal or pelvic mesh operations experience minor pain and discomfort anywhere from 24 to 72 hours after surgery, and some slight bleeding that occurs a few hours after surgery. This type of surgery is less invasive than most other treatments for POP and SUI, it does tend to have a higher complication rate, ranging anywhere from seven to 21 percent of procedures. Consequently, the FDA reported in 2011 that in the six years prior, it had received nearly 4,000 reports of complications due to transvaginal mesh operations. The most common complications include:
Dating back to around 2006, many lawsuits have been filed and won against vaginal and pelvic mesh manufacturers. Billions of dollars in compensation have been recovered for plaintiffs for physical and emotional damage, medical bills and injuries. Although these manufacturers have settled thousands of lawsuits, it is estimated that over half of the suits filed against them are still pending in state and federal court.
C.R. Bard was the first manufacturer to lose a transvaginal mesh case, suffering a $3.6 million dollar verdict to a woman who was injured by the company’s device. Since then, companies such as Ethicon (J&J subsidiary), American Medical Systems, Boston Scientific, Coloplast and Cook Medical have all been brought to court for multi-million dollar lawsuits.
In January 2016, the FDA announced the reclassification of transvaginal mesh used to surgically repair POP from a moderate-risk device to a high-risk device. In its announcement, the FDA stated it was giving all manufacturers of current mesh on the market 30 months to submit proof that their devices are safe and effective as proven by clinical trials. For new POP mesh, the FDA now requires the manufacturer to submit a premarket approval application with data demonstrating the effectiveness and safety of the devices before it receives FDA approval and is released to the medical market.
Page last reviewed and updated: November 21, 2019