Between 20% and 40% of all women will suffer from stress urinary incontinence, usually after childbirth. In addition, about 2% of women will develop symptoms of pelvic organ prolapse. Transvaginal mesh is similar to surgical mesh used for hernia repair and other stabilization procedures but it is intended to be implanted “transvaginally” or through the vagina rather than through a traditional abdominal surgery.
Uses for Transvaginal Mesh
Stress Urinary Incontinence
Stress urinary incontinence (SUI) the unintentional loss of urine that occurs due to pressure on the bladder caused by reaching, laughing or physical activity. It is more common in women, particularly in those who have carried a pregnancy or who are overweight and is caused by weakening of the pelvic floor muscles. In some cases, the muscles can be strengthened with exercise, but many women continue to have episodes of SUI or will require surgery.
Pelvic Organ Prolapse
Pelvic organ prolapse (POP) occurs when one or more of the pelvic organs such as the uterus, bladder or intestines drop from their normal position. It occurs when the muscles of the pelvic floor are injured or weakened due to childbirth, surgery or for other reasons. In severe cases, the pelvic organs may “prolapse” or begin to protrude from the vagina or into the rectum. In a few cases, pelvic floor muscles can be strengthened with exercise but more severe cases will require surgical correction.
Transvaginal Mesh Complications
Though it has been used successfully in millions of surgeries, repairs done with transvaginal mesh have been determined to be more likely to result in complications following surgery.
Transvaginal mesh complications may include:
- Vaginal wal erosion
- Organ perforation
- Urinary tract infections
- Infection at area of mesh implantation
- Scar tissue formation
- Vaginal shrinkage
- Nerve damage
- Chronic pain
- Emotional distress from chronic health conditions
- Need for additional treatments
Symptoms of transvaginal mesh complications may include
Complications from transvaginal mesh failure may require revision or repair surgery. In some cases, the side effects may be serious and result in permanent injury or death. Any symptoms of transvaginal mesh failure should be reported to a health care professional immediately.
Transvaginal Mesh and the FDA
Surgical mesh has been in use for hernia repair since the 1950s and was put into use for gynecological reconstructive procedures such as POP and SUI in the 1970s. The first product marketed for transvaginal mesh was not introduced until 1996 and until 2008, surgical mesh used for transvaginal implantation was categorized as a “Class II” medical device by the Food and Drug Administration, indicating that it was a medical device which may pose medium risk in the event of a failure.
Many of the transvaginal mesh product on the market had never been tested in humans but were approved under a fast-track pathway. The manufacturers were allowed to claim that their transvaginal mesh was similar to other products, namely surgical mesh, already on the market and to avoid costly clinical trials.
In 2008, after a high number of adverse events involving the use of transvaginal mesh were reported to the FDA, the agency recategorized it as a Class III medical device indicating a higher level of potential danger and which would require a safety review before marketing of new products. A safety notification was issued in October 2008 regarding the high number of reports and potential reclassification.
Thousands of reports of serious adverse events were received by the FDA between 2005 and 2010 and in July of 2011 a second safety communication was issued updating the concerns of transvaginal mesh which had resulted in nearly 4,000 adverse event reports, including multiple deaths.
In May of 2014, a proposed order was published by the FDA, which would require premarket approval for surgical mesh products intended to be used in transvaginal repair of pelvic organ prolapse. Premarket approval would require that clinical studies be conducted before new mesh products could enter the market. The order went into effect in January of 2017 and though it requires clinical testing for new transvaginal mesh products, those already on the market are not required to submit clinical testing
In September of 2017, the FDA issued a safety alert specifically regarding synthetic materials which are used in the manufacture of composite-type transvaginal mesh made by Boston Scientific.
Transvaginal Mesh Lawsuits
More than 100,000 lawsuits have been filed against manufacturers of transvaginal mesh products including Endo, Ethicon/Johnson & Johnson, C.R. Bard, and Boston Scientific. Women or family members of those who were injured by transvaginal mesh should consult a legal expert regarding possible compensation for medical costs, pain and suffering and other financial concerns.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
- Stress Incontinence, Mayo Clinic 8/2017
- Pelvic Organ Prolapse, Mayo Clinic 10/2017
- Endo Sets Aside $775 Million to Settle Remaining Mesh Lawsuits, Bloomberg Markets 8/2017
- J&J to Pay $20 Million in Vaginal-Mesh Case as Other Trials Loom, Bloomberg 4/2017
- Urogynecologic Surgical Mesh Implants, U.S. Food and Drug Administration 8/19/2017