Device name: Transvaginal mesh
Manufacturer: Johnson & Johnson – Bard – American Medical Systems – Boston Scientific
Approved uses: Surgically implanted vaginally to improve pelvic organ prolapse – a condition when a woman’s uterus, bladder, or rectum slips out of place.
Mesh Erosion into the vagina, bladder, intestines and uterus
Mesh Contraction – that leads to vaginal shrinkage
Urinary Problems including recurrence of prolapse and/or incontinence,
Development of urinary retention
Bowel, bladder, and blood vessel perforation during insertion,
dyspareunia (pain with sexual relations),
fistulas and recurrence of prolapsed organs
Related topics: Composix Kugel Hernia Mesh Patch, Medical Devices
Common Misspellings: trans vaginal mesh, transvaginal mesh, vaginal mesh, vaginal mesh repair, transvaginal surgical mesh, trans vaginal surgical mesh, vagina mesh
Vaginal Mesh Complications
Vaginal Mesh is a device that is surgically implanted through the abdomen or vagina to improve pelvic organ prolapse, a condition that occurs when a woman’s bladder, uterus or rectum fall out of place. In 2011, the FDA issued an updated warning stating vaginal mesh shows little evidence of improving POP and that the risks outweigh the potential benefits.
A study conducted in 2005 by the Journal of Obstetrics & Gynecology found more than 15 percent of women experienced vaginal mesh erosion where the mesh erodes into the vagina, which causes pain, pelvic pain, and infections. Other potential problems include dyspareunia (pain with sexual relations), fistulas and recurrence of prolapsed organs or contraction of the mesh, which leads to vaginal shrinkage.
Some women have undergone additional surgery to remove or repair the mesh, however it is difficult to remove fully, causing life-long pain and suffering. Manufacturers report that more than 100,000 women underwent surgery for prolapse, 75,000 of which were vaginally inserted.
Unlike FDA drug approvals, many medical devices are cleared without clinical trial data requirements. If you have experienced pain, infections, bladder or urinary problems, or other serious side effects due to vaginal mesh surgery, contact a LegalView attorney for a FREE case consultation.
Pelvic Organ Prolapse Symptoms and Treatments
Woman who have had multiple childbirths or a hysterectomy may experience a common condition known as pelvic organ prolapse. A pelvic organ prolapse occurs when the ligaments that hold the pelvic organs in place become weakened or stretched, causing these organs to slip out of place. While the bladder is the most common organ that slips out of place, the urethra, uterus, vagina, small bowel, and/ or the rectum slip out of place also.
In addition to childbirth and surgery, pelvic organ prolapse can be made worse by anything that puts pressure on your belly. Other causes include: being overweight, a long-lasting cough, frequent constipation, or pelvic organ tumors.
Older women are more likely to have this condition, but it also runs in families.