FREE CASE EVALUATION: 1-800-632-1404
Tens of thousands of women receive a transvaginal mesh (TVM) device each and every year from numerous suppliers: American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson. Thousands of women have been injured through no fault of their own, including vaginal erosion, pain, urinary problems, bleeding, infection and more. Our attorneys are representing women in all fifty states and Canada who have been injured. For a free case evaluation, call 1-800-632-1404.
FDA Sets Meeting
The US Food and Drug Administration (FDA) will convene a meeting of the Obstetrics-Gynecology Devices Panel of the Medical Devices Advisory Committee on September 8-9, 2011. It is our opinion that he purpose of the meeting is to consider regulatory changes that may improve the understanding and effectiveness of transvaginal mesh devices. Some of the regulatory changes being considered include:
- A change in risk classification of mesh used for transvaginal POP repair from Class II to Class III, which would require manufacturers to submit premarket approval applications, including relevant clinical data for these devices.
- Clinical studies to address the risks and benefits of mesh used to treat POP and SUI.
- Expanded post-market monitoring of device performance.
Currently the mesh used for transvaginal POP repair is classified under Class II, which allows the devices to be cleared for market under the FDA’s 510(k) approval process. This means that as long as the device is “substantially equivalent” to existing products, they will be approved. A change from class II to class III would require a significant increase in testing before a device is allowed to be sold, and would furthermore require a supplement be filed with the FDA any time a change is made to the device that may effect safety or effectiveness of the device.
As one example of why this is important, our firm is also representing children and adults who received the Advanced Bionics HiRes90k cochlear implant device. It is alleged that Advanced Bionics did not tell the FDA when it changed a critical component in the device, and further did not even test the device as changed under actual or simulated use conditions. The end result? A component that is failing more than 33% of the time, a figure unheard of in the medical device industry.
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