The lawyers at The Dunken Law Firm are representing women across the country who have suffered transvaginal mesh injuries after undergoing a procedure to correct a pelvic floor disorder. We are currently reviewing and accepting claims in every city in Delaware, which includes:
If you have found yourself to be a victim of defective transvaginal mesh, contact our firm today and find out your legal rights, for free.
The U.S. Food and Drug Administration (FDA) has demonstrated concerns regarding the safety of transvaginal mesh, but have not yet issued any product recalls. Transvaginal Mesh is a surgical medical device, derived from either animal tissue or synthetic materials. It is implanted into patients needing support for weakened muscles or organs due to a pelvic floor disorder.
Since the device gained market approval in 1996, two safety communications have been issued from the FDA, one in 2008 and the other in 2011. The first safety alert was prompted by over 1,000 reports of serious complications related to transvaginal mesh being used to correct stress urinary incontinence (SUI) and pelvic organ prolapse (POP). After reviewing medical studies published between 1996 and 2011, the FDA released their 2011 updated safety alert. This alert informed the public of their conclusion that transvaginal mesh used to repair POP may not improve the quality of life for patients when compared to non-mesh repair methods
In 2016, the FDA reclassified transvaginal mesh used for POP as a high-risk medical device, requiring manufacturers to submit pre-market approval applications with evidence in support of their device being safe and effective for POP. The major manufacturers of transvaginal mesh devices which will be affected include:
The FDA has continued its efforts to evaluate the risks of transvaginal mesh. An advisory committee meeting was scheduled for February of 2019 to further discuss additional evidence and weigh the benefits versus the risks.
Women have frequently reported the following serious side effects after transvaginal mesh implantation:
Our lawyers have the experience and the knowledge to help you pursue compensation for your transvaginal mesh injuries. Time is of the essence, as the state of Delaware allows only two years from the date of the injury for victims to file a product liability lawsuit.
Contact our office today so we may set up a free consultation and review your claim.