Illinois Couple Sues Ethicon LLC for Vaginal Mesh Injuries
By Amanda Antell
Donna and Darryl Baker of Illinois are suing Ethicon LLC for the injuries Donna sustained from their vaginal mesh product, the TVT. The plaintiff had the device implanted into her to treat her pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
After Donna had the device implanted May 12, 2005, she allegedly suffered vaginal mesh side effects. These side effects included debilitating pain, mesh erosion, mesh infection and other vaginal mesh complications. To fix this problem, Donna underwent corrective surgery and had the vaginal mesh implant removed.
According to the vaginal mesh implant lawsuit, at no point before or after the procedure was Donna or her physician aware of these possible complications. She states that the company knew or should have known about the possible side effects she suffered, and that they had the responsibility to warn her and other women who used their product.
The Bakers are suing Ethicon LLC and its parent company Johnson & Johnson for being directly responsible for manufacturing, selling, distributing and marketing a dangerous drug. The charges in their vaginal mesh implant lawsuit include negligence, false advertising, concealing information and misrepresenting a product.
Overview of Vaginal Mesh Complications
Ethicon’s product, the TVT sling, is a vaginal mesh system implanted into the patient’s lower pelvic region to prevent POP and SUI. This product has been on the market for more than 11 years, with more than 1.5 million patients using them throughout the world. However, like many vaginal mesh implant systems, the TVT sling has come under litigation for the debilitating side effects they caused women. The plaintiffs suing Ethicon allege that they were not properly warned of the possible vaginal mesh side effects.
Vaginal mesh implants became widely used in the early 2000s as a popular SUI and POP treatment option. Vaginal mesh implants are designed to hold the lower pelvic organs inside the body, as to avoid organ prolapse, as well as help control bodily functions such as urination. When vaginal mesh implants were first designed, it was initially thought that the mesh was made of a biologically-safe material that would last long-term inside humans. It would be directly planted in the area of infected tissue, and the tissue would ideally grow and build up its original structure, using the mesh as a base.
By October 2008, the U.S. Food & Drug Administration (FDA) received more than 1,000 vaginal mesh injury reports, and issued a public alert about the complications associated with vaginal mesh. The announcement stated that the side effects were not rare, and instructed patients to get revision surgery immediately if they experienced complications. In 2011, the FDA issued another public announcement regarding vaginal mesh complications, advising patients to consider different alternatives to treat their POP and SUI.
Many of the vaginal mesh devices went through the FDA’s 510(k) Premarket Notification System, which allowed the products to be approved for market after proving they worked in equal efficiency to a similar product already on the market. Therefore, many medical experts believe many of the devices did not undergo sufficient medical testing.
Additionally, it was recently required that vaginal mesh manufacturers conduct post-market testing on their products, and submit the results to the FDA accordingly.
Vaginal Mesh Litigation Movement
Thousands of women claim that Ethicon’s vaginal mesh products caused inflammation of their pelvic tissue, chronic pain and other injuries. In many cases, the plaintiffs had to undergo multiple revision surgeries to correct the problem.
The vaginal mesh implant MDL is In Re: Ethicon Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2327, in the U.S. District Court for the Southern District of West Virginia, Charleston Division.
File a Vaginal Mesh Lawsuit Today
If you believe that you or a loved one have been the victim of a vaginal mesh injury, you have legal options. Please visit the Transvaginal Mesh, Vaginal Sling, Vaginal Mesh and Bladder Sling Class Action Lawsuit Investigation. There, you can submit your claim for a free legal review and if it qualifies for legal action, a seasoned vaginal mesh lawyer will contact you for a free, no-obligation consultation. You will be guided through the litigation process at no out-of-pocket expenses or hidden fees. The vaginal mesh attorneys working this investigation do not get paid until you do.
All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.
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