The Food and Drug Administration (FDA) has announced plans to make changes to the fast-track system for getting many medical devices on the market without premarket testing, but for some women the slow-acting agency announcement is too little too late. In July, the FDA issued a second, stronger-worded warning that complications from mesh may not be “rare” as the agency had previously stated in 2008. Instead there may be a 10 percent complication rate, says the FDA warning, based on adverse reaction reports coming into the agency. Those reports are believed to represent just a fraction of what occurs in the real world. The FDA will convene a panel of experts in September to discuss mesh, but in the meantime it remains on the market and it is estimated that about 75,000 women receive the medical device for pelvic organ prolapse every year.
One woman tells Florida Today about feeling like she has barbed wire inside of her after she had synthetic surgical mesh implanted to treat pelvic organ prolapse. Four women from the Melbourne area of Florida are now part of dozens of lawsuits that have been filed against mesh manufactures involving hundreds of women from 34 states. A federal judge in West Virginia is overseeing the discovery process. The lawsuits can be settled or sent back to the plaintiff’s state for a jury trial.
Pelvic organ prolapse affects up to 50 percent of women over the age of 50 and is an organ slippage due to weakened pelvic muscles. Most women who have been implanted with mesh say the cure was far worse than the pelvic organ slippage or their incontinence, also treated with mesh.
Pain is one symptom along with mesh migration and erosion through tissues and organs. Repeated infections are common and often incontinence returns and people are unable to work. Many turn to multiple surgeries to try and have the mesh removed, which is likened to removing gum from hair.
If you have suffered due to implanted synthetic surgical mesh, you may be feeling pain and return to the same doctor for solutions. But many doctors receive their education about mesh from sales representatives for the pharmaceutical companies and are unaware of the multitude of side effects. Many doctors believe their patients are imagining the problems and some doctors will refuse to further treat the women. However, as this unfolding story shows, you are not alone and the symptoms are not in your head.
The Farah & Farah law firm understands that there is an enormous underreported problem with synthetic surgical mesh and we want to discuss your injuries to provide you with options for compensation. Call our surgical mesh injury lawyers in Florida at 1-800-533-3555 so we can begin the conversation.