What is pelvic organ prolapse?
Which vaginal mesh products are affected?
What are some signs and symptoms of pelvic organ prolapse?
What is the FDA doing about it?
What do I do if I have been affected?
What is pelvic Organ Prolapse?
Pelvic organ prolapse is the result of a pelvic organ like your bladder, moves from its normal spot within your lower belly and pushes against the vagina walls. This may occur when the muscles in your pelvic organs are weakened or stretched from childbirth or surgery.
Which Vaginal Mesh Products Are Affected?
The most commonly reported affected vaginal mesh products are;
- Gynecare, Gynemesh, and Ethicon products of Johnson & Johnson
- Avaulta, Pelvicol and Pelvisoft products of C. R. Bard
- Advantage Sling, Obtryx, Perfyx, and Pinnacle products of Boston Scientific and
- Spar, Miniarc, Monarc, Apogee, Perigee, and Elevate products by American Medical Systems
Any surgical mesh used to for Pelvic Organ Prolapse has a risk of failing or erosion.
What are some signs and symptoms of pelvic organ prolapse?
Symptoms of pelvic organ prolapse include:
- Feeling pressure against the vaginal wall. (most common)
- Feeling full in your lower belly.
- Feeling as if something is falling out of your vagina.
- Feeling a pull or stretch in your groin.
- Pain in your lower back.
- Releasing urine without meaning to, or needing to urinate more frequently.
- Pain in your vagina during sex.
- Having bowel complications, such as constipation.
Pelvic organ prolapse can be made worse by anything that puts pressure on your belly, such as:
- Being very overweight (obesity).
- A long-lasting cough.
- Frequent constipation.
- Pelvic organ tumors.
Older women are more likely to have pelvic organ prolapse and it can also run in families.
What is the FDA doing about it?
The FDA issued a notification to healthcare practitioners informing them to the complications associated with transvaginal surgical mesh to treat Pelvic Organ Prolapse. The FDA had received over nearly 1,000 reports of complications from the use of surgical mesh and the most frequent complications were erosion, infection, pain and urinary issues. The FDA identified common side effects from using surgical mesh implants which included;
- Erosion (exposure, extrusion, or protrusion)
- Pain (including during intercourse)
- Infections
- Urinary problems
- Bleeding
- Organ Perforation
- Recurrent prolapse
- Neuro-muscular problems
- Vaginal scarring/shrinkage
- Emotional issues
The FDA disclosed they recommend that surgical mesh used for transvaginal repair for Pelvic Organ Prolapse be reclassified from Class II to Class III which would create a higher requirement for manufacturers before they can sell vaginal mesh.
What do I do if I have been affected?
Click on the banner below if you have developed serious complications followed by a surgery involving transvaginal mesh and someone will be able to assist you.