What is pelvic organ prolapse?
Pelvic organ prolapse (POP) occurs when the muscles that normally hold pelvic organs in place become weakened. Stretching of these muscles can allow pelvic organs such as the bladder or uterus to fall or “prolapse” from their normal place and push against the vaginal walls or rectum. POP is most common after childbirth or surgery.
What is stress urinary incontinence?
Stress urinary incontinence (SUI) occurs when physical movement causes inadvertent release of urine (incontinence). SUI may occur after movement such as laughing, sneezing or reaching puts pressure on the bladder. It is most common in women who have weakened pelvic muscles or weakened sphincter muscles in the neck of the bladder.
What is transvaginal mesh?
Transvaginal mesh is a fibrous, net-like material which is used to stabilize weakened pelvic and bladder tissues. It is a medical device that implanted as part of a surgical repair to correct conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Transvaginal mesh is similar to other surgical mesh implants used for procedures such as hernia repair. However, it is implanted through the vaginal opening rather than as part of an abdominal surgery.
Because it is similar to other types of surgical mesh, transvaginal mesh was approved under the FDA 510(k) pathway which does not require clinical testing. Many women who have undergone transvaginal mesh implantation have developed complications or experienced serious side effects due to the implant.
What are the symptoms of transvaginal mesh complications?
Transvaginal mesh is used in thousands of gynecologic and urologic repair procedures every year. In 2011, based on high numbers of adverse event reports, an FDA review concluded that transvaginal mesh procedures caused a greater risk of complications than non-mesh repairs.
Vaginal mesh complications may include:
- Erosion through vaginal wall or soft tissues
- Organ perforation may occur if mesh erosion is severe
- Urinary tract infections or other problems
- Infection of area of mesh implantation
- Scar tissue development in vagina or other areas
- Vaginal shrinkage due to mesh contraction
- Nerve damage or chronic pain in pelvic or abdominal organs
- Emotional distress due to chronic health conditions and need for additional treatments
Symptoms of transvaginal mesh complications may include:
- Bladder symptoms – difficulty urinating, urinary frequency or urgency, blood in urine, recurrent urinary tract infections
- Vaginal symptoms – vaginal pain, vaginal bleeding, abnormal discharge, painful intercourse
- Abdominal symptoms – abdominal pain, painful movement, swelling, inflammation
Signs or symptoms of transvaginal mesh complications should be reported to a healthcare professional immediately. Complications related to transvaginal mesh may require additional revision or repair surgeries. In some cases, adverse effects may be severe, may result in permanent disability or could be life-threatening.
Has transvaginal mesh been recalled by the FDA?
Despite thousands of reports of serious harm caused by transvaginal mesh, including multiple deaths, it has not been recalled by the Food and Drug Administration. The FDA has strengthened warnings multiple times and required that additional safety studies be performed but several companies continue to manufacture and market the devices.
Have transvaginal lawsuits been settled?
Tens of thousands of lawsuits have already been filed for injuries caused by transvaginal mesh. Many of these lawsuits have already been settled, but thousands more remain in federal, state and local courts.