C.R. Bard Inc., a medical device manufacturer, sold vaginal mesh products made of a plastic resin that its manufacturer had cautioned should not be permanently implanted in humans, according to a Bloomberg report based on unsealed court records.
Chevron Phillips Chemical Company, the manufacturer of this plastic, advised that the plastic should not be permanently implanted in people. Lawyers for the women who have filed personal injury claims say that executives of Davol, now a unit of Bard, ignored Chevron’s recommendations and even tried to cover up its use of the plastic in vaginal mesh devices.
U.S. District Judge Joseph Goodwin ruled in June that a series of emails regarding the resin mesh raised “an issue of material fact about whether Bard was aware its conduct was practically certain to cause injuries.” Goodwin is overseeing 20,000 lawsuits against Bard, Boston Scientific Corp., Johnson & Johnson, Endo Health Solutions Inc., and American Medical Systems, alleging serious injuries from vaginal mesh products.
Reason for Health Risk
Transvaginal mesh products have been used in procedures for women suffering from pelvic organ prolapse or stress urinary incontinence. Instead of easing the discomfort, the mesh products have sometimes caused pelvic pain, infection, erosion of the mesh through the vaginal wall, internal organ perforations and other serious complications.
The transvaginal mesh approach has created health risks for thousands of women. Because the mesh tends to migrate away from the initial site and sometimes protrudes through the vaginal wall, it can get entangled with nearby internal organs and become almost impossible to remove.
In 2011, the U.S. Food and Drug Administration warned that the surgical placement of mesh to repair pelvic organ prolapse may expose women to greater risk than other surgical options without any added benefit.
Prior to the mesh implants, surgeons used a woman’s own tissue to create a sling that was stitched in place to keep organs contained. But after the success of abdominal hernia treatments using synthetic mesh, medical manufacturers developed a less invasive treatment for women with prolapse or incontinence.
The FDA has ordered all manufacturers of transvaginal mesh to conduct studies to assess the safety of their products.
Need Legal Help?
When you undergo a medical procedure, you expect that your safety and comfort will be top priorities. But if you have suffered complications from a defective medical product, you may need additional procedures and you may have a right to seek compensation from the manufacturer.
If you or a loved one has been injured due to a transvaginal mesh procedure, contact our South Carolina personal injury attorneys at Joye Law Firm. You may be able to seek compensation through a product liability lawsuit against the manufacturer of a defective medical product. Call 855-565-3560 or use our online form so our attorneys can offer you advice about your rights.