Albany, NY (PRWEB) June 20, 2013
Two common conditions among aging women in the US, are Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence, also known as ‘sudden urinary incontinence’ (SUI). According to the National Association for Continence (NAFC), approximately half of all women over the age of 50 complain of symptoms associated with POP.* With baby boomers moving towards retirement age, POP and SUI represent a burgeoning issue in women’s health. The NAFC notes that from 2010 to 2050, the total number of women undergoing surgery for POP is estimated increase by 48.2%.*
In reporting on TVM lawsuits, LawyersandSettlements.com noted that while transvaginal mesh surgery is one of the methods used to treat POP and SUI, the FDA issued a Safety Communication (7/13/11)** alerting healthcare providers and patients to potential serious TVM complications. The TVM warning included the FDA's summary of published scientific literature on TVM from 1996 - 2011; the summary found:
- Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
- Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
- There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
- While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
LawyersandSettlements.com spoke with Dr. Brian Murray in order to gain his perspective on the alleged TVM complications. Dr. Murray, a urologist and surgeon from Albany, New York who performs upwards of 200 procedures per year, sees about 10 percent of transvaginal mesh surgeries as remedial in nature--in other words, subsequent pelvic surgeries required to repair, or remove mesh as a result of transvaginal mesh complication.
“When we do see problems, they are memorable,” Dr. Murray told LawyersandSettlements.com in a recent interview. “But there are two sides to the issue. There certainly have been problems with mesh. Often it is too tight or it has been put in the wrong place.” Adds Dr. Murray, “there was not enough regulation when the mesh first came to market [in the 1990s].”
Things have changed. As of January 3, 2013, the FDA mandated TVM manufacturers to conduct postmarket surveillance studies on transvaginal mesh implants. The mandate included 95 postmarket study orders to 34 manufacturers of urogynecologic surgical mesh for POP, and 14 postmarket study orders to seven manufacturers of mini-slings for SUI.****
Left untreated, POP and SUI can be extremely painful and inconvenient for an increasing number of women. According to figures released by the US Food and Drug Administration (FDA) in the report, "Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse" (July, 2011), more than a half-million women in the US underwent surgery to treat POP and SUI in 2010.”***
“Pelvic organ prolapse is a big problem we have to tackle,” Dr. Murray says. “There are more and more women in the baby boomer generation that will face this, and we have to figure out how to deal with it.”
Recently, transvaginal mesh lawsuits stemming from alleged TVM complications were consolidated into a multi-district litigations (MDL). These include the following TVM lawsuits, all in U.S. District Court, Southern District of West Virginia: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2325); In re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation (MDL No. 2326); In re: C.R. Bard, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2187); and In re: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2327). LawyersandSettlements.com provides consumers with updates on TVM lawsuits.
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*National Association for Continence (NAFC), Statistics-Pelvic Organ Prolapse, updated 7/25/;12, http://www.nafc.org/media/statistics/pelvic-organ-prolapse/
*** "Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse", p. 6, FDA, July 2011, http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf
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