Transvaginal Mesh Injuries and Complications. A West Virginia federal judge denied Boston Scientific’s request to vacate a 2014 multi-million dollar pelvic mesh verdict from 2014.
U.S. District Judge Joseph R. Goodwin upheld the $14.3 million award in a medical device liability case involving Boston Scientific’s Obtryx Transobturator Mid-Urethral Sling System.
The verdict came in November 2014, with a small group of plaintiffs sharing the award. The plaintiffs claimed the Boston Scientific sling was defectively designed in a way that led to serious complications.
The personal injury attorneys at Parker Waichman are knowledgeable about transvaginal mesh side effects and can answer questions about filing a pelvic mesh side effects lawsuit.
The devices at issue in this case and other pelvic mesh/transvaginal mesh lawsuits are implanted to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. These conditions can occur when a woman’s pelvic structures have weakened or stretched due to childbirth, surgery, or aging. The mesh devices are intended to provide support for pelvic organs.
Plaintiffs allege the pelvic mesh implants have caused problems and complications including:
- mesh protrusion into the vagina
- organ perforation
- bladder infection and irritation
- urinary tract obstruction
- bladder, bowel, or urethra injury
- pelvic blood vessel damage
- painful intercourse
- bleeding after intercourse
Many women need additional surgeries to remove protruding mesh devices and repair organ damage. Some women say they have ended up worse off than when they sought treatment for pelvic organ prolapse or incontinence.
Plaintiffs in pelvic mesh lawsuits allege that manufacturers of transvaginal mesh manufacturers misrepresented the safety and efficacy of the devices. Transvaginal mesh devices have high failure rates, high complication rates, and they fail to perform as intended, leaving women with severe and irreversible injuries including bleeding, pain, and organ perforation. The U.S. Food and Drug Administration (FDA) conducted a review of the published research from 1996 to 2011 to evaluate mesh safety and effectiveness. According to the FDA, the review showed that transvaginal POP repair with mesh does not improve results or quality of life over traditional non-mesh repair.
FDA Warnings about Pelvic Mesh Complications
The FDA concluded that a mesh implant “may put the patient at risk for requiring additional surgery or for the development of new complications. Removal of the mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh might not be possible.”
In January 4, 2016, the FDA issued two orders for transvaginal mesh devices. The first order reclassifies vaginal mesh devices from Class II, for moderate-risk devices, to Class III, which includes high-risk devices. The assigned risk category depends on how likely the device is to cause serious and permanent health consequences or even death. The second FDA order requires manufacturers to submit premarket approval (PMA) applications to support the safety and effectiveness of transvaginal surgical mesh. The FDA now questions whether vaginal mesh implants are appropriate treatment when compared to traditional surgical procedures.
Boston Scientific Appeal Denied
Boston Scientific challenged the jury verdict, claiming that flaws in the jury instructions and impermissible closing arguments tainted the jury’s judgment. The company argued that in closing arguments, the plaintiffs’ attorney invited the jury to decide the case based on their own sympathy, not on the facts and law presented. Such arguments are not permitted. Boston Scientific says the resulting pelvic mesh verdict ran contrary to the evidence presented during the trial.
Judge Godwin, however, disagreed, finding the pelvic mesh verdict was legally sound and supported by the evidence. The judge noted that using a directed verdict or ordering a new trial to undo a jury’s award is an extraordinary option that should occur only in exceptional circumstances and Boston Scientific failed to show such circumstances in this case.
Three of the original four plaintiffs will share in the final jury award. The fourth plaintiff had reached a settlement with Boston Scientific before the jury award was issued. Other recent verdicts have also gone against Boston Scientific. In May 2015, a Delaware jury awarded a plaintiff $100 million. The plaintiff alleged that Boston Scientific’s Pinnacle and Advantage Fit transvaginal mesh devices left her in constant pain and unable to have sex. A Texas couple was awarded $34.5 million (reduced from an original $73 million granted by the jury).