Every year, hundreds of thousands of hernias, stress urinary incontinence, and pelvic organ prolapse issues are treated with surgical mesh. Unfortunately, problems arise in approximately 1 percent of the procedures, and in 2011, the Food and Drug Administration (FDA) stated that “Complications are not rare.” The most common complaints include infection, urinary problems, pain, incontinence, prolapse recurrence, or erosion of the product through the vaginal epithelium.
According to the FDA, most of the complaints reported are associated with a recalled product, so it is no longer on the market. However, the issues caused before the recall can be severe and possibly life threatening. Davol, Ethicon, and Gore Medical are three of the numerous manufacturers associated with these recalled devices.
Complications can differ according to the condition the product is used to treat, but the one thing they all have in common is that they failed the patient. In some cases, failure of the medical device exasperated the initial condition. Severe infections and complete medical device failure may lead to life threatening situations.
Some potential complications include the following:
- Pelvic bleeding
- Erosion of the medical device
- Recurrence of urinary incontinence
- Painful intercourse
- Urinary tract obstruction
- Urethra or bladder injury
- Local infection
- Fluid build-up
- Bowel perforation
The FDA reports that the most common complaint of the surgical mesh is erosion. Problems such as erosion often require numerous surgeries to treat and repair, and the effects can be debilitating. The placement of the medical device shifts, so it moves through surrounding tissue and organs. The implantation of the mesh takes time to remove safely, and often requires reconstructive surgery to repair the damage.
While there are no specific factors leading to potential complications, the FDA has issued recommendations for surgeons. The recommendations reduce the risk of injury and include:
- Obtaining special training for every type of procedure.
- Be aware of potential risks.
- Check for complications, specifically perforations.
- Inform each patient of potential risks.
A well-informed surgeon is the first step in patient safety. It is important the surgeon is aware of the risks associated with each procedure. Aftercare is another step in ensuring patient health. However, the patient must inform each health care provider of the placement and follow guidelines to ensure their own health and safety.
A defect in the product may cause a liability issue for the manufacturer. Did a product defect cause injury or death? The consumer must establish a link between a product defect and the injury in order to file a suit for their surgical mesh problems.