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FDA Proposes Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse

On May 1, 2014, the U.S. Food and Drug Administration announced a proposed rule to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. This proposed rule change acknowledges that there is insufficient evidence on the safety of mesh products for POP repair and would require any transvaginal mesh to undergo premarket approval to ensure the mesh's safety and effectiveness before it can be marketed and implanted in women. This classification change would remove mesh products for POP from the much maligned 510K process, which does not require premarket approval. In making this significant announcement, the FDA identified numerous risks with the use of transvaginal mesh for POP repair, including mesh exposure and extrusion, vaginal scarring, pelvic pain, shrinking and tightening of the mesh, incontinence and infections such as pelvic abscesses. Comments on the proposed rule changes are due by July 30, 2014. Needless to say, the mesh manufacturers and their lobbyists are certainly expected to fight this proposed change.

Arias Ozzello & Gignac LLP continue to represent clients who have been implanted with defective or recalled transvaginal mesh products. If you believe you may be suffering from adverse medical complications as a result of a defective or recalled transvaginal mesh product, fill out a contact form, or call Arias, Ozzello & Gignac LLP at (310) 670-1600 or e-mail Mike Arias.

Settlement in Transvaginal Mesh Lawsuits Announced While FDA Looks at Stricter Classifications

A proposed settlement has reportedly been reached in Endo International Plc’s transvaginal mesh lawsuits. The settlement will resolve around 20,000 claims against the company, alleging women suffered serious side effects from the use of transvaginal mesh. 

Endo has agreed to pay around $830 million to resolve approximately 20,000 claims linked to transvaginal mesh products made by American Medical Systems Inc., a unit of Endo. The lawsuits alleged that some of the transvaginal meshes eroded, causing incontinence and pain. Endo still faces around 23,000 claims linked to transvaginal meshes, while other companies also face lawsuits.

News of the settlement came one day after the US Food and Drug Administration (FDA) announced possible changes to how transvaginal mesh products used to treat pelvic organ prolapse (POP) are classified. The FDA’s proposal recommends reclassifying the mesh from a class II (moderate risk) to a class III (high risk) and would require  companies to submit an application for premarket approval so the FDA could evaluate the device’s safety and effectiveness.

Johnson & Johnson Sold Transvaginal Mesh Implant after FDA Ordered Company to Stop Sales

Johnson and Johnson (J&J) continued the sale of its Gynecare Prolift transvaginal mesh implant despite a 2007 letter from the Food and Drug Administration directing them to halt sales until the FDA further reviewed the product.  J&J determined that their product was “substantially equivalent” enough to another product it already had on the market, so it simply continued to sell the device despite the FDA’s warning. 

The FDA eventually cleared the device about a year later; however, this does not bode well for J&J who already faces lawsuits regarding their transvaginal mesh implants.  The FDA did not sanction J&J because they later complied with the FDA’s instructions to complete a new application for the device, but many believe this kind of brazen disregard for the FDA’s direct orders indicates the challenge the FDA faces when it comes to enforcing its regulations on major pharmaceutical companies. 

Thousands of women have experienced severe complications from the transvaginal mesh implants including recurrence of prolapse or incontinence, severe pain, erosion of the mesh, and infection. Oftentimes, these complications require women to undergo additional painful and costly surgeries.  California defective device attorneys currently represent women across the United States facing such complications from these transvaginal mesh devices.


Judge Sets Trial Date in Bard Avaulta Mesh Cases

U.S. District Judge Joseph R. Goodwin recently set a February 5 trial date in West Virginia for the C.R. Bard Avaulta vaginal mesh cases. This trial date covers the first of nearly 600 federal cases against Bard for its vaginal mesh implant. Judge Goodwin is also overseeing trials against Johnson & Johnson, American Medical Systems, and Boston Scientific for failures in their comparable mesh implants.

In July 2011, the FDA issued a universal safety warning against these devices for a high risk of adverse side effects. Over 75,000 women a year have these mesh devices implanted and hundreds, if not thousands, suffer immense pain and have to undergo additional surgeries. The FDA has recently ordered all manufacturers of the vaginal mesh to conduct studies based on the high rates of failure, complications, and organ damage.

The attorneys at Arias Ozzello & Gignac are investigating claims against the manufacturers of the vaginal mesh devices. If you or someone you know had a mesh device implanted and is experiencing severe pain or has undergone corrective or removal surgeries, contact us today for a free consultation. You may be entitled to compensation for your pain, suffering, and other damages.


Judge Sets Trial Date in Bard Avaulta Mesh Cases

U.S. District Judge Joseph R. Goodwin recently set a February 5 trial date in West Virginia for the C.R. Bard Avaulta vaginal mesh cases. This trial date covers the first of nearly 600 federal cases against Bard for its vaginal mesh implant. Judge Goodwin is also overseeing trials against Johnson & Johnson, American Medical Systems, and Boston Scientific for failures in their comparable mesh implants.

In July 2011, the FDA issued a universal safety warning against these devices for a high risk of adverse side effects. Over 75,000 women a year have these mesh devices implanted and hundreds, if not thousands, suffer immense pain and have to undergo additional surgeries. The FDA has recently ordered all manufacturers of the vaginal mesh to conduct studies based on the high rates of failure, complications, and organ damage.

The medical device attorneys at Arias Ozzello & Gignac are investigating claims against the manufacturers of the vaginal mesh devices. If you or someone you know has a mesh implant and is experiencing severe pain or has undergone corrective or removal surgeries, contact us today for a free consultation. You may be entitled to compensation for your pain, suffering, and other damages.


Mesh Recall Overview

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are two very common problems for women, especially those over 40. Childbearing, age, and weight gain can all contribute to the progression of these conditions. Both can be quite embarrassing for women, as the sagging of the pelvic organs and pressure placed on the bladder can lead to “accidents” when a woman laughs, sneezes, or coughs. Both POP and SUI are far more common in older women, but younger women can also suffer from these conditions.

To counteract the problems of POP and SUI, researchers created a device known as the transvaginal mesh treatment, or TVT. TVTs combine tough, durable plastics to create a sling or net that holds up the pelvic organs, releasing the pressure on a woman’s bladder and solving the SUI problem in many cases. At first glance, these devices seemed to be the perfect solution to age- and stress-related urinary incontinence caused by organ prolapse.

However, it soon became apparent that several manufacturers had real problems with TVT devices, and that some of these problems could lead to destructive and health-damaging side effects for the women who had undergone TVT surgery. These problems led to a widespread call for an effective vaginal mesh recall, although the Food and Drug Administration has so far declined to order the recall of these products.

Between 2008 and 2010, almost 3,000 complaints were lodged with the FDA about side effects and problems from TVT procedures. In one clinical trial over 15 percent of the patients in whom TVTs has been implanted suffered severe complications. Some of the most serious complications involved erosion of the mesh into the surrounding organs. Pieces of mesh have been found in the vagina, rectum, and bladder of patients who were given TVTs. The TVT procedure can also lead to severe pain, infection, and most importantly, a recurrence of the original symptoms. Many women who had TVT surgery were forced to undergo a second surgery to repair damage caused by the TVT or to fix the POP or SUI conditions the TVT had failed to solve.

The FDA may not have chosen to recall vaginal mesh products, but it has issued statements saying that the side effects of TVT procedures are "not rare" and that other forms of surgery can provide equal or better benefits to women suffering from POP and SUI. However, it is estimated that in 2011, at least 75,000 women were given TVTs as part of the surgical repair of prolapsed organs.

If you have undergone TVT surgery, it is very important that you contact your medical professional as soon as you experience any side effects at all. TVT complications have a way of growing in severity, so the sooner you catch the problem, the easier it will be to solve. If you have suffered from side effects, it is important to contact an expert personal injury attorney immediately, as well. A faulty vaginal mesh lawyer can examine the facts of your case and advise you on the best way to seek damages for your medical bills and pain and suffering.


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