Pelvic organ prolapse (POP) is the condition that began the chain of events that have led to about half of the vaginal mesh lawsuits that have been filed around the country. Plaintiffs’ lawyers contend that women who have suffered through POP have been hit with a second injustice. The difference between these two injustices is that the latter could have been prevented if vaginal mesh manufacturers put safety ahead of profit.
Pelvic organ prolapse is a condition where the organs in the pelvic region, such as the uterus, bowel, or bladder may protrude into the vagina because of a weakness in the network of muscles, ligaments, and skin around the vagina. The resulting symptoms vary based on the type of prolapse and may include pain, prolapse sensation and bowel, bladder, and sexual problems.
Types of prolapse include cystocele (prolapse of the bladder), enterocele (herniated small bowel, often occurring following a hysterectomy), rectocele (prolapse of the rectum), prolapse uterus and vaginal vault prolapse. The prolapse of the bladder often causes the urethra to also prolapse. The term urethrocele refers to a urethral prolapse and cystourethrocele refers to when both the bladder and urethra prolapse. These conditions often result in stress urinary incontinence (SUI) (leakage caused by activities such as laughing, sneezing, coughing, exercise, etc.).
Certainly, these are stressful conditions for women who are trying to lead normal, active lives. The idea of a transvaginal mesh surgery to put the condition to bed once and for all was very appealing to women and their doctors looking for an answer. It seemed also too good to be true. And for many women, it was.
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It is worth noting again and again: this is an extremely common condition that affects women of all ages, colors, shapes, and sizes. Clearly, however, elderly women bear the brunt of the problem: the fastest growing segment of the population in North America is women over the age of 80. It is expected that the elderly female population will continue to steadily grow until 2050. Women over the age of 50 are most affected by pelvic organ prolapse, with about 30-50% of women experiencing prolapse in their lifetime. By the age of 79 women are reported to have an 11-12% chance of having at least one surgery for prolapse or incontinence. It is probable that these numbers will continue to rise given the aging population (Drutz and Alarab, 2006). The direct medical cost of prolapse surgery was estimated to be over $1 billion annually in the United States (Subak et al., 2001).
Synthetic meshes are commonly used for anterior (front) vaginal wall repair. Surgical meshes are also referred to as surgical tape or sling. The most widely used synthetic material in surgical meshes is polypropylene. Although considered to be the best material for pelvic organ prolapse surgery because of the low incidence of bacterial infections, some complications arise from its use including exposure (erosion through the vagina (~13%), pain syndromes and dyspareunia (painful sexual intercourse (~63%) and often cause inflammatory tissue reactions (Cervigni et al., 2011). Prolift® (Ethicon Women’s Health and Urology, a division of Johnson & Johnson) is an example of a polypropylene mesh for pelvic organ prolapse. Because of concerns surrounding polypropylene meshes, other products have entered the market including Avaulta® (CR Bard, Inc), a biosynthetic, collagen-coated polypropylene mesh. In a study on Avaulta®, 21.6% of subjects had erosion, and 35.1% had a recurrence of anterior wall prolapse (Culligan et al., 2010).
A retrospective study, at a single site, was undertaken on all patients who underwent Prolift® mesh repair over a four-year period (between 2005 and 2009) and is currently in press (de Landsheere et al., 2011). The follow-up duration ranged between 15 to 63 months. Results demonstrated a global surgical intervention rate of 11.6%. Surgery was required due to mesh-related complications (3.6%), urinary incontinence (6.9%), and prolapse recurrence (3%). The mesh exposure rate was reported to be 2.7% in this study. Mesh exposure rates have been reported to vary between 3.2% and 17% in other large studies on mesh devices. The study also reported that 8.3% of patients who were continent prior to Prolift® mesh repair subsequently required insertion of a suburethral sling for urinary incontinence. The authors also noted that the rates of complications may be underestimated as some patients presenting with a side effect to the mesh repair product may have chosen not to undergo further surgery.
A literature review on 40 trials conducted in 3773 women with varying types of prolapse, found that there was very little published information on mesh in prolapse surgery and as a result insufficient evidence of benefit to women regarding symptoms and quality of life (Maher et al., 2010).
On July 13, 2011, the FDA released an updated safety communication on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. In 2008, the FDA had received over 1,000 reports of complications associated with surgical mesh devices used to repair pelvic organ prolapse and urinary incontinence. The update recognizes that adverse effects from transvaginal placement of surgical mesh are not rare. Notices concerning mesh have also been posted by Health Canada. Between 2008 and 2010, the FDA received 2,874 additional reports of complications with 1,503 reports associated with pelvic organ prolapse repairs and 1,371 associated with urinary incontinence repairs. The most frequent complications reported were erosion through the vagina (exposure), organ perforation, urinary problems, infection, bleeding, and pain during sexual intercourse. Because of the high number of reports, the FDA conducted a review on published scientific literature and found no evidence that pelvic organ prolapse repair with mesh has any added benefit over non-mesh repair and presents risks that are not present in non-mesh surgery. The FDA will provide another report at a later date once they have completed their evaluation of urinary incontinence literature regarding mesh devices.
The FDA recognized a previously unidentified risk, mesh shrinkage, or contraction. Both mesh contraction and erosion can lead to severe pain, painful sexual intercourse, or the inability to engage in sexual intercourse. The FDA also noted that erosion can be painful to the male partner as irritation and pain may occur to the penis during intercourse when the mesh is exposed.
On September 8-9, 2011, the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee convened to discuss the safety and efficacy of transvaginal surgical mesh for pelvic organ prolapse and urinary incontinence. Mesh was previously approved by the FDA without clinical testing under the 510(k) exception by demonstrating that these vaginal mesh implants were substantially equivalent to other similar products already on the market. The FDA ruled that existing products can remain on the market, but will seek post-market studies of existing products to determine the safety of mesh to treat pelvic organ prolapse. The FDA has also recommended that vaginal mesh products be moved to Class III FDA category, the highest risk category of medical devices. This move would require companies to conduct clinical trials prior to seeking FDA approval.
The complications associated with surgical mesh for pelvic organ prolapse can be debilitating to a woman and have not been linked to a single brand of mesh. Adverse events have been reported by numerous manufacturers of these devices. The FDA urges adverse events be voluntarily reported through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Lawsuits have been filed around the United States against both Prolift® and Avaulta® manufacturers as well as other mesh device manufacturers (this is the list) These lawsuits have been filed on behalf of women who have had surgery(s) or will require surgeries to remove these devices and to treat complications arising from defects in these devices.
Do you qualify for a vaginal mesh lawsuit? If you do want to make a claim, call us at 800-553-8082. Or get a confidential and free online consultation here.
References for This Blog Post:
Cervigni M, Natale F, La Penna C, Saltari M, Padoa A and Agostini M. Collagen-coated polypropylene mesh in vaginal prolapse surgery: an observational study. Eur J Obstet Gynecol Reprod Biol. 2011. 156(2):223-7.
Culligan PJ, Littman PM, Salamon CG, Priestley JL and Shariati A. Evaluation of transvaginal mesh delivery system for the correction of pelvic organ prolapse: subjective and objective findings at least 1 year after surgery. Am J Obstet Gynecol. 2010. 203(5):506.e1-6.
De Landsheere L, Ismail S, Lucot JP, Deken V, Foidart JM and Cosson M. Surgical intervention after transvaginal Prolift mesh repair: Retrospective single center study including 424 patients with 3 years median follow-up. Am J Obstet Gynecol. 2011, doi: 10.1016/j.ajog.2011.07.040.
Drutz HP and Alarab M. Pelvic organ prolapse: demographics and future growth prospects. Int Urogynecol J Pelvic Floor Dysfunct. 2006. 17 Suppl 1:S6-9.
FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence. October 20, 2008. http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm
FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse. July 13, 2011.
Health Canada – Notice to Hospitals – Surgical Mesh – Complications Associated with Transvaginal Implantation of Surgical Mesh for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse
Maher C, Feiner B, Baessler K, Glazener CMA. Surgical management of pelvic organ prolapse in women. Cochrane Database of Systematic Reviews 2010, Issue 4.
Subak LL, Waetjen LE, Van den Eaden S, Thom DH, Vittinghoff E, Brown JS. Cost of pelvic organ prolapse surgery in the United States. Obstet Gynecol. 2001. 98:646–651