Product Liability Update: Pelvic Mesh Trials

Fulton & Barr, Attorneys at Law
Fulton & Barr: The Legal Pad
Wednesday, September 10, 2014

vaginal mesh in hand

Transvaginal mesh devices came onto the market in 1996, as a way for doctors to help patients suffering from pelvic organ prolapse and femalestress urinary incontinence.

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are medical conditions that mostly occur when the pelvic floor muscles and tissues become weak, which is predominately a consequence of childbirth. Pelvic organ prolapse can cause varying levels of pain, the bulging of organs at the vaginal opening, sexual difficulties and urine leakage in association with stress urinary incontinence.

According to the FDA, surgical mesh started being used in the 1950s to repair abdominal hernias; however, in the 1990s gynecologist began using it to for the surgical treatment of SUIs and repairing POPs. Eventually, medical manufacturers responded to this demand by creating transvaginal mesh kits that cater specifically to that type of surgery.

The creation of these “kits” gradually went from just including the specifically designed transvaginal surgical mesh to including insertion tools, tissue anchors and surgical technique instructions.

Unfortunately, these medical devices that were designed to help have caused more harm than good.

The FDA issued its first warning about transvaginal mesh device complications in October 2008, after reviewing over 1,000 reports from nine surgical mesh manufacturers. More warnings were issued in 2011 and again this year.

vaginal-mesh-surgery-2

In May, the FDA issued a proposal to reclassify transvaginal mesh devices used for POP from class II to class III, which calls for stricter pre-market testing of new products. Until being questioned now, products have been able to appear on the market without rigorous pre-market testing—obtaining FDA approval based on their similarities to formerly approved devices.

sad woman

This proposal comes out during the multidistrict litigations (MDLs) of six transvaginal mesh manufacturers in the U.S. District Court for the Southern District of West Virginia. The six manufacturers associated with these cases are American Medical Systems, Boston Scientific, C.R. Bard, Johnson & Johnson’s Ethicon, Coloplast Corp. and Cook Medical. More than 22,000 lawsuits were included in these MDLs and Chief Judge Joseph R. Goodwin will preside over all of them. Thousands of state lawsuits have been filed as well.

In most recent MDLs news, Huskey v. Ethicon No. 12-5201 , the federal jury awarded 52-year-old Jo Huskey 3.27 million dollars for medical costs, past and future pain and suffering, and loss of consortium for her husband. Her case provided enough evidence to prove that Johnson & Johnson’s Ethicon Inc. unit negligently failed to warn her doctor about the defectiveness of the device.

This was the second case to go to trial in Western Virginia federal court. Ethicon won the first case back in February.

Jane Akre, National News Editor of Mesh Medical Device News Desk made this statement about the results of Huskey v. Ethicon: “This verdict is critically important to women and their families from across the U.S. who have needlessly suffered from injuries related to pelvic mesh implants.”

Akre exclusively covers the medical mesh trials for We are Mesh Survivors—a united group of vaginal implant survivors who are using their stories to warn others about defective transvaginal mesh devices and pushing for these medical products to be removed from the market until proven safe for use.

One survivor Teresa from Ohio expresses on their website, “Mesh nearly killed me and nearly took everything I owned away from me…. I want an answer from JNJ as to why their profits are more important than my life and other injured women’s’ lives.”

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