On July 13, 2011 the FDA released a Safety Communication regarding the usage of synthetic mesh materials for the repair of pelvic organ prolapse. While the FDA has neither taken the vaginal mesh off the market nor called for a recall, they did state that a variety of complications have been reported by patients and surgeons alike, and wish to make this fact known to surgeons and patients alike. Some of thos complications include mesh erosion, dyspareunia and infections.
If you are considering vaginal mesh or bladder sling surgery, the FDA recommends that you ask the following questions from your surgeon prior to the surgery:
- Are you planning to use transvaginal 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 pelvic organ prolapse (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 vaginal mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
- If bladder sling 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 bladder sling surgery and for how long?
- Which specific side effects should I report to you after the vaginal mesh 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 vaginal mesh complications?
- If I have a complication related to the bladder mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
- If a tranbsvaginal mesh is to be used, is there patient information that comes with the product, and can I have a copy?
If you or a loved one has already had a vaginal mesh product manufactured by Gynecare, Ethicon, Johnson & Johnson, C.R. Bard, American Medical Systems or Boston Scientific and have had mesh complciations such as mesh erosion, contact a vaginal mesh lawyer today for a free consultation.