FDA Announces Strict Proposal Affecting Transvaginal Mesh Litigation

FDA Announces Strict Proposal Affecting Transvaginal Mesh Litigation

Posted By Golomb & Honik || 13-Jul-2014

On the heels of a Dallas jury ordering Johnson & Johnson to pay compensatory damages as a result of a design flaw in their product, the U.S. Food and Drug Administration (FDA) has made a call for stricter safety regulations regarding the transvaginal mesh device.

In April, Johnson & Johnson, one of several manufacturers of transvaginal mesh (TVM) implants, was ordered by a jury in Dallas to pay $1.2 million to a woman injured when her TVM eroded inside her. Thousands of patients have been subjected to additional and corrective surgeries because of malfunctioning implants. Despite many reported issues with the mechanically cut TVT-O mesh, it and others such as the TVT-Secur and the TVT-Abrevo are still being widely used. The Dallas verdict represents the first TVM lawsuit which deals with a "bladder sling" rather than a pelvic organ prolapse (POP) product, and is projected to set the standard for future cases.

As early as 2008, the FDA has had knowledge of issues with the TVM products after receiving more than 1,000 reports of patients suffering complications after having the devices implanted. They released a "Public Health Notification" at that time, and issued an additional warning to women in 2011 of an exceptional health risk associated with the mesh.

This week, the FDA issued a press release indicating explicit risks associated with the mesh products and outlining plans to reduce those risks in an effort to improve the safety and effectiveness of the mesh. Upon finalization of the proposed changes, manufacturers must supply premarket clinical test results showing that their product offers POP patients a reasonably safe and effective treatment option. The proposal does not affect surgical mesh products used for hernia repair.

The proposed changes come after years of lobbying from patient advocates and victim support groups. Currently, about 60,000 TVM cases are outstanding nationwide against several different manufacturers. Victims report a variety of complications, including pain, infection, bleeding, and urinary incontinence. The proposal would allow the FDA to classify the mesh products as a "high risk" medical device.

National Defective Medical Device Lawyers

If you have suffered complications as a result of your transvaginal mesh implant, you could have a case against the manufacturer. Call the defective medical device lawyers at Golomb & Honik today for a consultation and to learn about your legal options. Our goal is to get you the greatest maximum recovery for your physical and emotional suffering.

To learn more about your legal options or to schedule a free consultation call the Philadelphia product liability lawyers at Golomb & Honik today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national defective medical device lawyers at Golomb & Honik have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.

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