Issues With Surgical Mesh Used For Pelvic Organ Prolapse (POP)

Surgical mesh is a medical device made from porous absorbable or non-absorbable synthetic material or absorbable biologic material used during surgery to repair weakened or damaged tissue. In women with certain gynecological problems, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse (pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched) or to support the urethra in order to treat urinary incontinence.

When POP happens, one or more organs (the bladder, uterus, rectum, the bowel, and/or the top of the vagina after a hysterectomy) bulge into the vagina and sometimes bulge beyond the vagina. It is estimated that between 30% and 50% of women experience POP during their lifetime, and 2% develop symptoms of POP.

On October 20, 2008, the U.S. Food and Drug Administration (FDA) notified the public regarding serious complications associated with surgical mesh placed through the vagina (known as transvaginal placement) to treat POP and stress urinary incontinence (SUI), which is when urine leaks during certain physical activities, such as coughing, sneezing, laughing, or exercise.

On July 13, 2011, the FDA updated its previous concerns about surgical mesh used to treat POP and SUI by stating that updated analysis of adverse events reported to the FDA “identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.” The FDA warned that the serious complications “are not rare” (the bold emphasis was in the original FDA update). The FDA update also noted that it is not clear that the use of surgical mesh for transvaginal POP repair is more effective than traditional non-mesh repair in all patients with POP (transvaginal POP repair with mesh does not improve symptomatic results or quality of life) and that it may expose patients to greater risk.

The FDA found that from 2008 to 2010, the most frequent complications reported to the FDA included mesh erosion through the vagina (the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh), pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems, many of which required medical or surgical treatment and hospitalization.

The FDA also found that mesh placed abdominally as opposed to transvaginally results in lower risks for mesh complications, that use of mesh for transvaginal repair to support the top of the vagina or the back wall of the vagina does not provide any added benefit compared to traditional surgery in which mesh is not used, and that while transvaginal repair to correct weakened tissue between the vagina and the bladder using mesh may provide an anatomic benefit compared to traditional non-mesh surgery, the anatomic benefit may not result in better symptomatic results.

The FDA update noted a previously unidentified risk of transvaginal POP repair with mesh that is known as mesh contraction (shrinkage), which may be associated with vaginal shortening, vaginal tightening, and vaginal pain. Mesh contraction and mesh erosion can lead to severe pelvic pain, painful sexual intercourse (for both women and men), or the inability to engage in sexual intercourse. Notably, the complications associated with the mesh have not been linked to any single brand of mesh.

The FDA recommends that health care providers recognize that in most cases, POP can be treated successfully without using mesh and thus the risk of mesh-related complications can be avoided.

Source

If you have suffered injuries or complications after use of mesh during pelvic organ prolapse repair surgery, you may have a claim for compensation for your losses. Medical malpractice attorneys may be  able to investigate the circumstances of your claim to determine if you have a medical malpractice case. Visit our website to be connected with medical malpractice lawyers in your local area who may be able to assist you with your claim. You may also reach us toll free 800-295-3959.

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This entry was posted on Sunday, September 4th, 2011 at 2:36 pm. Both comments and pings are currently closed.

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