The United States Food and Drug Administration (FDA) has ordered two manufacturers to halt sales of surgical mesh commonly used to correct pelvic organ prolapse. A detailed article on the FDA action is available here.
Recently, the FDA ordered two companies—Coloplast and Boston Scientific—to stop selling surgical mesh used for transvaginal repair of pelvic organ prolapses. The FDA states neither device manufacturer provided reasonable assurance the products are safe or effective in the long term.
What Is Pelvic Organ Prolapse?
Pelvic organ prolapse occurs when the tissue and muscle structure which supports the bladder, uterus, or rectum weaken and become loose. This allows internal organs to press against or drop into the vagina. Surgical transvaginal mesh products are commonly used to repair this condition.
Tens of thousands of lawsuits have been filed in recent years against the manufacturers of surgical mesh. These lawsuits cite numerous adverse events following the use of transvaginal surgical mesh, including bleeding, severe pain, and the need for additional surgery to correct damage. The number of complaints led the FDA to reclassify vaginal mesh products as high-risk devices in 2016.
About the Action
The FDA order to discontinue sales affects only those mesh products used to repair pelvic organ prolapse. It does not apply to surgical mesh used to correct other medical conditions—including urinary incontinence or hernias. The FDA gave both Coloplast and Boston Scientific ten days to submit plans to withdraw these products from the market.
Other Legal Actions Move Forward
In a related story, medical-device manufacturer Johnson and Johnson (J&J) has agreed to pay $9.9 million to settle a lawsuit brought by the State of Washington. The State Attorney General claimed J&J knew the risks of surgical mesh devices, yet failed to disclose them to the public. The complications outlined in the suit include chronic pain, urinary complications, and pain during intercourse. The settlement will assist women who suffered harm after receiving pelvic mesh implants.
Graves McLain is Here to Help
If you or a loved one has been injured by Transvaginal Mesh, call Graves McLain right away at 918-359-6600 or fill out a free consultation form online. When you call one of our experienced Tulsa, Oklahoma Transvaginal Mesh Attorneys, we will speak with you for FREE and determine the best course of action.
We review every detail of your situation at no cost to you—and fight hard to protect your rights. Trust our team, we are here to help. At Graves McLain, you will never pay an attorney’s fee up front—and you owe us nothing until we win your case. At Graves McLain, we don’t get paid until you do.
Graves McLain, Serious Lawyers for Serious Injuries