After initially calling problems with synthetic surgical mesh “rare” the Food and Drug Administration (FDA) in a July 13, 2011 Alerts and Notices made an about-face and said the complications are “not rare” as first reported in an advisory issued October 20, 2008.
When the tissues that hold pelvic organs in place become weak or stretched, pelvic organ prolapse (POP) can occur.
Symptoms: may include a feeling that the bladder, the uterus or the rectum has bulged or prolapsed into the vagina and sometimes past the vaginal opening. This should not be a painful condition but is obviously troubling.
When you laugh, cough, sneeze or exercise a small amount of urine may leak. This condition might be Stress Urinary Incontinence (SUI). Women diagnosed with both POP or SUI may be treated with an implantable surgical mesh medical device, usually synthetic or in rare cases, absorbable biologic material. The mesh is permanently sewn into the pelvic area to reinforce a weakened vaginal wall or to support the urethra to treat incontinence.
These is not intended to be removed, which is interested because no clinical trials were required before pelvic mesh was cleared for the market by the FDA.
From 2005 until 2010 there were approximately 4,000 reports of complications from surgical mesh reported to the FDA. Ultimately 15,000 adverse event reports were received by the FDA. Since the reporting of complications is not mandatory, that number may represent only a small portion of what is occurring in the real world. Lawsuits resulted with more than 107,000 filed in one federal court in West Virginia in multidistrict litigation (MDL). The MDL was closed and most cases remanded back to state court or settled.
In the July 13, 2011 announcement, the FDA says the following may be a symptom of a mess complication after it has been implanted through the vagina, called a transvaginal placement:
Many of these problems have resulted in more surgical intervention and hospitalization. In some cases, women and men have endured a dozen or more surgeries in an attempt to remove the mesh, likened to removing gum from hair and very difficult if not impossible to accomplish, according to most surgeons.
With all of the side effects, the FDA in a review of published scientific literature from 1996 to 2011 concluded that “transvaginal POP repair with mesh does not improve symptomatic results or quality of live over traditional non-mesh repair.” Non-mesh repair uses stitches to tighten the pelvic floor, which requires additional surgical skills.
No single brand of mesh has been singled out for complications.
Learn More: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse, July 2011, FDA Center for Devices and Radiological Health. #