In July 2011, the FDA released a safety communication warning healthcare providers of the serious risks associated with surgical mesh used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Specifically, the FDA stated that complications were not rare, and that surgery with the mesh may be no better than traditional surgery options that don’t use mesh.
POP repair surgeries may include cystocele and rectocele. Unfortunately, complications have been found with both.
Types of POP Repair Include Cystocele and Rectocele
POP occurs when the muscles and tissues that hold the pelvic organs in place become weak and stretched as a result of childbirth, surgery, menopause, weight gain, smoking, and genetics. No longer able to provide adequate support, the weakened tissues allow one or more of the organs to drop or bulge (prolapse) into the vaginal wall, and sometimes past the vaginal opening.
The type of POP repair depends on which organs are affected, and may include the following:
- Cystocele—bladder prolapse
- Rectocele—rectal prolapse (end of the large intestine, or rectum)
- Uterine prolapse
- Vaginal prolapse
- Enterocele—herniated small bowel
Mesh was initially incorporated into POP surgical repair because it offered more support to the affected organ and helped shore up surrounding muscles and tissues. Since the risk for recurrence of prolapse is high in women who have cystocele surgery and rectocele surgery, the hope was that surgical mesh would help sustain the repair. The FDA received many reports, however, or cystocele mesh complications and rectocele mesh complications.
Cystocele Mesh Complications and Rectocele Mesh Complications
During cystocele surgery, transvaginal mesh is inserted through the vagina to help act as a barrier and to hold the bladder in place. The mesh is also intended to help stop related problems like incontinence.
A rectocele occurs when the thin wall of tissue separating the rectum from the vagina weakens, allowing the front of the rectum to bulge into the vagina. During rectocele surgery, excess stretched tissue is removed through the vagina, and a mesh patch may be used to support and strengthen the wall. (Surgery may also proceed from the abdomen, anus, or perineum.)
Though surgical mesh does seem to provide better support for pelvic organs, cystocele mesh complications and rectocele mesh complications made the improvement a moot point. The FDA, in its 2011 warning, mentioned that it had received nearly 3,000 reports of vaginal mesh complications between 2008 and 2010, with the most common being mesh erosion through the vagina. Mesh erosion can require multiple surgeries to repair and may be extremely debilitating.
Other cystocele mesh complications and rectocele mesh complications included pain, infection, bleeding, pain during sex, organ perforation, urinary problems, recurrent prolapse, vaginal scarring/shrinkage, and neuro-muscular problems. Many required additional surgical treatment and hospitalization.
Cystocele Surgery and Rectocele Surgery
Before releasing it’s latest warning, the FDA reviewed published scientific literature on POP mesh repair from 1996 – 2011. They found that POP repair with mesh, including cystocele surgery and rectocele surgery, does not improve symptoms or quality of life more than non-mesh repair. They added that even though the mesh may better support the organs, “this anatomic benefit may not result in better symptomatic results.”
A Cystocele or Rectocele Lawyer May be Able to Help
If you or a loved one has experienced an injury as a result of mesh used during cystocele surgery or rectocele surgery, you may be eligible for compensation in a vaginal mesh lawsuit. Contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.