Women who suffer from stress urinary incontinence (SUI) or pelvic organ prolapse (POP) may be implanted with transvaginal mesh (TVM), a medical device that gives added support when weakened or damaged tissue is being repaired. According to statistics, up to 70,000 women have this medical device implanted each year, illustrating a reliance on TVM to correct certain medical problems.
However, the American Association for Justice reported the impact of dangerous medical devices such as these in 2013 and noted that there were early detections of problems linked to TVM even during its rising popularity in the early 2000s. TVM has been known to cause:
- Erosion or hardening of the device; and
- Difficulty in removal of the device.
Additional surgeries are required to repair complications with mesh erosion and still do not solidify a guaranteed resolution to the adverse effects originally caused by TVM. These procedures mean costly hospital stays, prolonged medical care, and a diminished quality of life for a medical device that the FDA said did not necessarily improve post-surgical outcomes in many cases.
The FDA issued a health safety warning in 2008 regarding the serious complications associated with TVM and followed up this notification with an update in 2011, alerting health care providers and patients that the documented instances were not uncommon.
Nearly 3,000 new problem cases associated with TVM were reported in a two-year period of time. Patients had suffered:
- Neuro-muscular problems;
- Vaginal scarring/shrinkage;
- Recurrent prolapse; and
- Emotional trauma.
Despite proof of medical device dangers, they have been put on the market without adequate testing or current FDA approval based on similar models that have been previously approved.
It is the responsibility of manufacturers to follow safety protocols regardless of any suggested similarities between its products. When defective devices cause injury to patients or when the public is not made aware of potential dangers associated with a product, manufacturers need to be held accountable.
If you or a loved one have been implanted with TVM or have undergone mesh-related repair surgery in Illinois, contact a Chicago product liability attorney today. Call [[title]] at [[phone]] for a free consultation.”