Cook Medical's surgical mesh is a product used to help alleviate Pelvic Organ Prolapse (POP) that afflicts at least one of two women in their lifetime. This vaginal mesh is also intended to treat female stress urinary incontinence (“SUI”), also known as intrinsic sphincter deficiency or ISD. This is another common condition in women. What happens is a woman leaks urine she experiences increased abdominal pressure from laughing, jumping, coughing, sneezing, or any other movement that puts pressure on the bladder. The mesh was created to act as a sling and help support a woman’s organs when their own lining tissue was weak. It was also used to help reinforce the vaginal wall and treat incontinence. If it worked, and it did for at least some women, it is a great medical device.
However, the mesh did not undergo rigorous testing like most FDA approved products; instead, it was fast-tracked through the controversial 501(k) application process that quickly admits products that are similar to existing ones. On July 13, 2011, the FDA released a safety communication announcing that there had been several thousand reports of POP/mesh complications. The mesh had been eroding and causing pain, infections, bleeding, urinary problems, and risk of organ perforation.
The Case Against Cook
Cook developed a porcine small intestine submucosa (SIS) graft mesh to market for POP and stress urinary incontinence (SUI). Plaintiffs allege that at the time this new product was brought to the market, Cook knew of the risk associated with its graft mesh devices. These risk should have been placed in the warning for doctors to see to make the best decisions with their patients. Of course, a stronger warning would have let to more doctors and patients making a different choice. Communicating all of the possible risks would have enabled the implanting physician to fully educate and inform the patient to obtain her informed consent before to the implantation of her Cook SIS graft mesh device.
If Cook did not know the risks, victims' attorneys are arguing that they should have. If this is the case, the contention is that Cook failed to adequately test the product before launch, failure to appropriately warn patients and healthcare providers of the severity and magnitude of risks and complications.Vaginal Mesh Injuries
Although the mesh was supposed to be implanted to support a failing organic tissue lining, it often eroded itself. The FDA states that some of the common symptoms of a defective vaginal mesh are
- Mesh erosion through the vagina
- Urinary complications
- Pain (particularly during intercourse)
- Organ perforation
Multiple failing meshes require numerous surgeries to replace them, requiring the patient to experience greater mental and physical stresses on their body.Cook Medical Surgical Vaginal Mesh
Unlike most synthetic meshes, Cook Medical’s version is made from pig intestines. Studies have been shown that Cook mesh is more likely to get infected, as well as having inferior tensile strength. Very recently a judge decided to include Cook in a multidistrict litigation, allowing its victims to consolidate their claims, even though Cook argued that the 15 (out of 42) surviving cases were not enough to combine.Current Surgical Mesh Cases
A victim of a degraded vaginal mesh was awarded $5.5 million after she underwent nine revision surgeries. Another victim was awarded $11.11 million after she had eighteen revision surgeries. The jury found the offending company, Johnson & Johnson, had made fraudulent misrepresentations and failed to adequately warn doctors and patients of the risks. In 2017, Boston Scientific took a $57.1 million verdict.
Cook has been able to avoid trials and continues to maintain that its mesh is “dramatically different” than the mesh products that are taking all of these verdicts. The prediction here is that argument is not going to hold up when these cases start going to juries. Ultimately, while you never know what will happen, we think the remaining cases will be resolved by a global settlement. Talks with Cook for such a settlement have alrady begun.Discussing Your Case
If you have experienced transvaginal mesh side effects or complications with the Cook's mesh product, you may be entitled to compensation. Talk to us online or call us at 800-553-8082.More Vaginal Implant Lawsuit Information