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New Vaginal Mesh FDA Warning

The FDA has issued a new warning for the vaginal Mesh surgical implant used for prolapse and urinary incontinence. This puts the mesh at a class III rather the class II. The new warning alerts physicians of the serious risk of using the mesh for women patients with prolapse or urinary incontinence.

FDA Issues High Risk Warning for Transvaginal Mesh

WASHINGTON — The FDA is warning transvaginal mesh products, a mainstay of Pelvic Organ Prolapse repair, carries a high risk for adverse events and as result the mesh will now carry a class III warning.

Prior to today’s announcement, transvaginal mesh carried a class II or moderate risk warning.
In addition, manufacturers of the devices will also be required to submit to a premarket approval application to support the safety and efficacy of surgical mesh for the transvaginal repair of pelvic organ prolapse.

“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, MD, MPH, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health said in a statement. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”

As part of the premarket approval application process, manufacturers will be required to address concerns about severe pelvic pain and organ perforation through a “rigorous PMA pathway.”

Manufacturers of transvaginal mesh for the treatment of pelvic organ prolapse will have 30 months to submit a PMA for devices already on the market, although manufacturers may submit an application before this time.

The FDA initially proposed these changes in 2014, when the agency said that they had identified “clear risks” associated with surgical mesh for repairing prolapsetransvaginally. In 2011, the FDA’s Obstetrics and Gynecology devices panel had recommended both of these changes to the agency. Transvaginal mesh manufacturers were ordered to conduct postmarket surveillance studies addressing concerns about the use of the device for transvaginal pelvic organ prolapse repair 3 years ago. In fact, the FDA has been increasing warnings for and conducting more research on the use of mesh for transvaginal POP repair, as far back as 2008.
In March 2015, Johnson & Johnson’s Ethicon unit paid out a $5.7 million settlement to a woman who sued the manufacturer over a transvaginal mesh implant. In August, an investigative report found several transvaginal mesh manufacturers linked to profit schemes and litigation over removal of the device.

The agency notes that these orders are not applicable to surgical mesh used for other indications, such as stress urinary incontinence or open (abdominal) repair of pelvic organ prolapse. Women suffering from a vaginal mesh are urged to contact a lawyer and the helpline to see if they can still file a lawsuit.


The post New Vaginal Mesh FDA Warning appeared first on Vaginal Mesh Lawsuit Helpline.

This post first appeared on Get A Vaginal Mesh Lawyer | Talcum Powder LawyersV, please read the originial post: here

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New Vaginal Mesh FDA Warning


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