According to a recent article by Businessweek, The U.S. Food and Drug Administration wrote a letter to 33 vaginal mesh manufacturers, including Bard and Johnson & Johnson, requiring that the companies study the potential vaginal mesh complications and rates of organ damage. The agency requested three year trials on safety and effectiveness.

Vaginal mesh was originally approved by 501 (k) approval process, where a medical device may be FDA approved if it is similar to other products currently on the market. However in some cases, the original device used to approve newer medical devices was recalled or voluntarily pulled from the market.

Both Johnson & Johnson and Bard have been named in several vaginal mesh lawsuits nationwide, which allege severe complications from the medical device, ranging from mesh erosion, mesh shrinkage, painful sex, severe pain and other complications.

Additional information about vaginal mesh complications can be found at www.legalview.com.

 

Tags: FDA, Vaginal Mesh

This entry was posted on Friday, January 13th, 2012 at 12:00 pm and is filed under Medical Devices, Personal Injury, Vaginal Mesh. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.