On July 13, 2011, the Food & Drug Administration (FDA) issued an update to Health Care Providers and the public at large warning of the serious health complications caused by surgical mesh, a medical device implanted in a patients' pelvic area. The mesh is most often used to address Pelvic Organ Prolapse (POP), a condition that occurs when the tissues that hold the pelvic organs in place become weak or stretched, or to treat urinary incontinence.
Concern regarding the surgical mesh emerged in 2008 when the FDA issued a Public Health Notification raising the issue. Almost 4,000 cases have been reported with a host of adverse effects that can significantly decrease a patient's quality of life including infection, severe pain, urinary problems and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation that occurred during the actual procedure. The final insult to injury for those suffering complications is that studies have revealed that this procedure may not be an effective form of treatment. Unfortunately for these consumers, this mesh is one of many medical devices entered into the market without patient testing. The proliferation of untested, defective medical devices has a grave impact on patients who don't have the luxury of simply returning it for a refund if and when a recall is issued. The FDA urges patients to be vigilant in their post operation follow up care and report any adverse effects immediately.
The impact of this failed medical device can be physically and emotionally painful for patients who have suffered through the procedure only to find that it was unsuccessful and further exacerbated their health problems. Untested medical devices can be dangerous to consumers who trust their health care providers to offer the safest and most reliable form of treatment for their ailments.
The FDA has issued the following list of questions that any patient considering surgical mesh should ask of their surgeon BEFORE agreeing to the procedure.
- Are you planning to use mesh in my surgery?
- Why do you think I am a good candidate for surgical mesh?
- Why is surgical mesh being chosen for my repair?
- What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
- What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
- Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
- If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
- What can I expect to feel after surgery and for how long?
- Which specific side effects should I report to you after the surgery?
- What if the mesh surgery doesn't correct my problem?
- If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
- If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
- If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?
For more information on this defective medical device, contact Ted Leopold.