A Delaware woman who suffered severe transvaginal mesh complications has won a $100 million jury award against the products’ manufacturer.

According to her transvaginal mesh lawsuit, plaintiff Deborah B. had the Pinnacle and Advantage transvaginal mesh products implanted in 2009 as treatments for pelvic organ prolapse and stress urinary incontinence. Both products are manufactured by defendant Boston Scientific.

Deborah’s implants allegedly led to severe transvaginal mesh problems. Despite two surgeries to correct the problems, she still retains parts of the implants in her body and continues to suffer related vaginal mesh complications.

The jury found that Boston Scientific had been negligent in its design and manufacture of the Pinnacle and Advantage implants and had failed to adequately warn patients and the medical community about the risk of transvaginal mesh complications.

The $100 million total award, $75 million of which was awarded as punitive damages, is the largest such award to date against a transvaginal mesh manufacturer. A company spokesperson says Boston Scientific plans to appeal the award.

Transvaginal Mesh Complications

Transvaginal mesh is a surgically-implanted device made of polypropylene plastic, used to treat pelvic organ prolapse and stress urinary incontinence. Pelvic organ prolapse occurs when a weakening of the pelvic muscles allows pelvic organs such as the bladder, rectum or uterus to drop into the vagina.

Stress urinary incontinence is a leakage of urine from the bladder during physical activity that creates pressure on the bladder. Both conditions sometimes happen after childbirth or a hysterectomy, or they may occur during menopause.

Treatment of those conditions with implanted mesh developed in the 1970s out of techniques used to repair hernias. The first device made specifically for treatment of stress urinary incontinence was approved by the FDA in 1996, and a device specifically for treatment of pelvic organ prolapse was approved in 2002.

Unfortunately, transvaginal meshes have been plagued with problems such as infection, organ perforation, erosion of the surrounding tissues, and pain during sex. The more severe vaginal mesh complications may require surgical repair. However, the revision surgery itself can be complicated by the body’s tendency to grow new tissue around the mesh.

Transvaginal Mesh Lawsuits

Boston Scientific continues to face more than 25,000 transvaginal mesh lawsuits. The plaintiffs similarly allege that transvaginal mesh complications result from faulty design of the implants. Boston Scientific denies the allegations.

The cases against Boston Scientific that have gone to trial have met with varying success. A Texas woman won a $73.4 million award, which was later reduced to $34 million. In Miami, four women won a total of $26.7 million, and a jury in West Virginia awarded plaintiffs $18.5 million.

In April 2015, Boston Scientific announced it had agreed to about $119 million in settlement payments to resolve a group of 2,970 transvaginal mesh lawsuits. All told, the company has set aside $1.1 billion to cover its legal expenses related to this litigation.

Boston Scientific is just one of several manufacturers facing transvaginal mesh lawsuits and bladder sling lawsuits. Others include C.R. Bard, American Medical Systems, and Johnson & Johnson’s Ethicon unit. Johnson and Johnson recently began settling Ethicon claims after losing a few high-profile cases. It’s estimated that the total number of transvaginal mesh lawsuits now pending is around 100,000.