Millions of dollars have been paid out in transvaginal mesh settlements by several different manufacturers of this problematic medical device. The damage, pain, suffering, and emotional toll that has been taken on so many of the women who had surgery with transvaginal mesh may never be fully repaid, but with settlement money, they at least have a chance to pay medical bills and get back on their feet.
Transvaginal mesh is a medical product that has been made by a number of companies, but never rigorously tested before being approved by the U.S. Food and Drug Administration (FDA). The result is that treatment for relatively common gynecological and urinary conditions in women led to organ damage, bleeding, pain, and multiple additional surgeries. If you were harmed by transvaginal mesh, you may be able to recover damages in a settlement.
What is Transvaginal Mesh?
Transvaginal mesh is surgical mesh that is designed to treat certain conditions in women by being inserted into the pelvic area through the vagina. The mesh is similar to surgical mesh, a tightly woven material used in other types of surgeries and made of either synthetic or biological materials, but it has been cut to be inserted vaginally and to support organs in the pelvic area.
Conditions treated with this mesh include pelvic organ prolapse, or POP, and stress urinary incontinence, or SUI. Both are caused by weakened tissues and muscles, often due to childbirth and pregnancy. Transvaginal mesh is used to support organs, like the uterus or bladder that are no longer being supported by surrounding tissues.
Traditionally this was done by making an incision in the abdomen to insert the mesh, but medical device manufacturers noticed there was a need for a product specifically designed to treat these conditions less invasively. They developed transvaginal mesh and kits with specialized tools so that gynecologists could treat SUI and POP right in the office. Instead of needing to do surgery in an operating room, a doctor could simply insert the mesh vaginally.
It is now thought by some experts that it is this office procedure that has caused so many complications. They argue that gynecologists were not well trained and were ill-equipped to vaginally insert the mesh. Furthermore, the office setting, instead of an operating room has been implicated in introducing infections to many of the women affected.
Complications that Led to Lawsuits and Settlements
Because the mesh in the transvaginal mesh kits was similar to other surgical mesh products on the market, transvaginal mesh was approved through the FDA’s 510(k) process. This allowed device makers to get their products approved quickly and without a need for rigorous testing. It was assumed that treating POP and SUI, less invasively and without a need for hospitalization would be safer, would give women shorter recovery times, and would have fewer complications.
This turned out to be wrong and thousands of women have suffered the severe complications from transvaginal mesh. Some of them have received settlements over these complications, but some women have even died. Over just five years, between 2005 and 2010 the FDA received nearly 4,000 reports through its adverse events reporting system, of complications from transvaginal mesh. The FDA has since upgraded transvaginal mesh to class III, which means it is considered to be a high-risk medical device.
Women and their doctors reported to the FDA a number of complications and symptoms including severe pain, excessive bleeding, incontinence, infections, worsening of the original condition treated with the mesh, and even organ damage. Many women making these reports required multiple additional surgeries to correct the damage and remove the mesh.
Most of these complications are caused by the fact that the mesh tends to erode into surrounding tissue in the pelvic region. This can cause pain, infection, and bleeding, but if the mesh moves far enough it can also perforate other organs, which can cause deeper infections, incontinence, and other serious issues. For many women the mesh became so imbedded in the tissue that surgeons could not remove all of it and pieces will remain inside them indefinitely.
Settlements by Manufacturer
Thousands of women started lawsuits over the complications caused by transvaginal mesh and many won settlement money. These women wanted justice and punitive damages, but also compensation for medical bills, lost wages, damaged relationships, and pain and suffering. Multiple companies made the device and so the lawsuits were often grouped together into large multidistrict litigation cases, or MDLs. Many of these companies ended up paying out transvaginal mesh settlements:
- Boston Scientific. In 2014 Boston Scientific was forced to pay several settlements. It paid $18.5 million in West Virginia when the jury awarded compensation to plaintiffs. In Florida, another jury awarded several women $26.7 million and later in the year a jury in Texas agreed on a $73 million settlement to just one plaintiff. That award included $50 million in punitive damages.
- Ethicon. This division of Johnson & Johnson settled out of court with several plaintiffs in 2015 for an undisclosed amount. It also had to pay jury-awarded settlements, including $3.2 million in West Virginia and $11 million in New Jersey.
- Coloplast. This Denmark-based medical device manufacturer settled 400 lawsuits over transvaginal mesh by paying out a $16 million settlement. Each plaintiff is expected to receive about $40,000.
- American Medical Systems. AMS, a division of Endo pharmaceuticals, settled transvaginal mesh cases earlier than most with a $54.4 million payout in 2013. They weren’t done, though, and in 2014 the company had to pay out around $830 million to settle another 20,000 lawsuits.
- C.R. Bard. Bard saw its first transvaginal mesh trial in 2013, which resulted in jury-awarded $2 million settlement. Bard appealed the decision, but a judge upheld it. The plaintiff representation had successfully made the case that Bard was negligent in not testing its product, in designing a faulty product, and in failing to warn doctors and patients of the risks. This was just one of multiple million dollar settlements that Bard would ultimately pay out to plaintiffs.
In most of the cases of transvaginal mesh settlements, the manufacturers made the choice to settle before going to trial. This often costs the companies less, as juries may award settlements into the billions of dollars. And, although the settled, most companies refused to admit to any wrongdoing.
The plaintiffs disagree with this strongly and have claimed that the various manufacturers of transvaginal mesh never warned them that there were such serious risks associated with using the devices. They also accuse the companies of failing to test their products fully, thanks to the expedited approval process allowed by the FDA.