FDA Releases Report Highly Critical of Vaginal Mesh Bladder Slings

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The FDA's July 13, 2011 published report recites complaints and warnings pertaining to the growing number of injuries sustained by women who have suffered severe complications relating to transvaginal mesh surgery. The independent investigation conducted by the New Jersey personal injury law firm of Mazie Slater Katz & Freeman indicates that vaginal mesh bladder sling products, primarily constructed of polypropylene, including but not limited to the Gynecare Prolift, Bard Avaulta, Boston Scientific Pinnacle and Uphold, and AMS (American Medical Systems) Apogee, Perigee, and Elevate have not met reasonable safety standards.

New Jersey Certified Civil Trial Attorney Adam Slater - Vaginal Mesh Lawsuits

Adam Slater, Esq.

Mr. Slater has extensive experience with vaginal mesh bladder sling cases, and with related issues. In a recent decision, the New Jersey Appellate Division affirmed a $2.1 million jury verdict Mr. Slater won for a woman with pelvic injuries.

On July 13, 2011, the FDA issued a strongly worded report and warnings based on the growing number of complaints of injuries suffered by the victims of vaginal mesh and bladder slings reported to the FDA and a review of current medical literature and studies. Specifically, the FDA stated: (i) Complications related to transvaginal mesh surgery are NOT rare; (ii) There is no evidence that transvaginal mesh repair is more effective than traditional non mesh repair; and (iii) Transvaginal mesh surgery exposes patients to greater risk than traditional non mesh repair. There are currently hundreds of vaginal mesh bladder sling lawsuits filed in the United States.

Adam Slater, a New Jersey certified civil trial lawyer at Mazie Slater Katz & Freeman (“Mazie Slater”) who has been litigating these cases since early 2008, has been appointed as plaintiffs’ Co-Liaison Counsel in the consolidated vaginal mesh bladder sling lawsuits proceeding in New Jersey State Court against Gynecare, Ethicon and Johnson & Johnson, which encompasses most of the cases pending against these defendants in the United States. The consolidated litigation is captioned In Re Pelvic Mesh Litigation/Gynecare, Superior Court of New Jersey, Law Division, Atlantic County, Master Case No. 6341-10, Case No. 291. A companion consolidated litigation venued in the same Court is In Re Pelvic Mesh Litigation/Bard, Master Case No. 6341-10, Case No. 292.

Mr. Slater commented on the FDA report and warnings: “This report by the FDA is consistent with what my law firm has found during the course of our investigation of more than one thousand of these cases; these products fail at rates much higher than ever disclosed by the manufacturers, and the failures devastate the women who are victimized by these products.” Mazie Slater has obtained thousands of internal Ethicon documents and is the only law firm to have multiple plaintiffs deposed in the New Jersey litigation.

According to the FDA, the FDA report was based on thousands of complaints by women who have suffered severe complications as a result of the Gynecare (Ethicon) Prolift Anterior, Posterior, and Total Pelvic Floor Repair Systems, Bard Avaulta Pelvic Floor Repair Systems, Boston Scientific Uphold and Pinnacle Pelvic Floor Repair Kits, American Medical Systems (AMS) Apogee, Perigee and Elevate Prolapse Repair Systems and related mesh products. These are medical devices, commonly referred to as pelvic mesh, vaginal mesh, and bladder slings, which are used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Mr. Slater commented further: “Our independent investigation indicates that vaginal mesh bladder sling products, primarily constructed of polypropylene, including but not limited to the Gynecare Prolift, Bard Avaulta, Boston Scientific Pinnacle and Uphold, and AMS (American Medical Systems) Apogee, Perigee, and Elevate have not met reasonable safety standards. In fact, in October 2008 and February 2009, the FDA issued the first Public Health Notifications concerning the use of mesh products in treatment of stress urinary incontinence and pelvic organ prolapse. After receiving over 1,000 reports and complaints at that time, the FDA warned of serious complications resulting from the placement of these mesh products, including the Gynecare Prolift, Bard Avaulta, Boston Scientific Pinnacle and Uphold and AMS Apogee, Perigee, and Elevate. These Notifications have been followed up with the most recent July 13, 2011 report and warnings.”    

Mr. Slater also commented with regard to the warnings provided with these pelvic mesh and bladder sling medical devices: “Our ongoing investigation indicates that Ethicon/Gynecare, Bard, Boston Scientific and AMS did not adequately disclose and warn of the significant risks of these products in their physician literature, patient literature, and websites. These inadequacies deprived women of the opportunity to make informed choices as to how they wanted their treatable medical conditions to be repaired, leading them to choose to have pelvic mesh permanently attached to the inside of their pelvis - often with catastrophic results.”

Mr. Slater also described the debilitating complications and injuries suffered by the victims of these product failures based on his law firm’s review of the medical records and data for hundreds of women: “The most frequent reported complications from these transvaginal mesh products include mesh erosion into the vagina, bladder, intestines and uterus, mesh shrinkage or contraction, mesh migration, mesh exposure, scar tissue formation, granuloma formation, infections, pelvic pain, urinary incontinence and development of urinary retention, dysuria (painful urination), dyspareunia (painful sexual relations), neuropathic pain, fistulas and recurrence of prolapsed organs. These complications have significantly decreased the quality of life many patients once enjoyed. The failure of the Gynecare Prolift, Bard Avaulta, Boston Scientific Pinnacle and Uphold, and AMS Apogee, Perigee, and Elevate, and other bladder sling and pelvic mesh products, can also lead to the need for multiple operations to try to remove the mesh and to repair extensive damage caused by the mesh. In many cases the mesh cannot be completely removed, permanently compromising a woman’s health.”

Mr. Slater has extensive experience with vaginal mesh bladder sling cases, and with related issues. In a recent decision, the New Jersey Appellate Division affirmed a $2.1 million jury verdict Mr. Slater won for a woman who suffered injuries including pelvic floor and pudendal nerve damage. Lintao v. Livingston, and County of Hudson, Superior Court of New Jersey, Appellate Division, Docket No.: A-0983-09T3

Contact NJ certified civil trial attorney Adam Slater and Mazie Slater Katz & Freeman for a free case evaluation.

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