After Injuries, FDA Orders Transvaginal Mesh Off The Market
Lawsuits against manufacturers of surgical mesh to treat pelvic organ prolapse have been filed in the tens of thousands after the first reports of possible side effects. Over the years, this medical device, also known as transvaginal mesh, has earned a reputation as dangerous given the number of women who have reported suffering injuries after its implantation. Given the legal risk and the number of lawsuits, all but two manufacturers have exited the market. At the height of the market for this mesh, there were 31 different makers of the product.
The remaining two manufacturers were ordered by the Food and Drug Administration in April 2019 to withdraw their products from the marketplace in light of the dangers posed by the mesh. The FDA, a regulator of all medical devices sold in the U.S., has the ability to withdraw its approval for any product as well as be removed from commerce. Here, the FDA’s decision followed years of advocacy by injured patients requesting that the FDA pull its approval of the mesh. Advocates began requesting that the FDA ban the product in 2011 after reports of injuries began to multiply.
The FDA reclassified the mesh as a Class III product in 2016. This is the designation that it gives to high-risk medical products. After that, the companies remaining in the marketplace were unable to provide the FDA with information that showed that the benefits of the products outweigh the risks. When the FDA ordered the product off of the market, it gave manufacturers ten days to submit their plans for it to remove the product from commerce. By the time the FDA’s decision was announced, most sales of the product had already stopped. For the two remaining product makers, transvaginal mesh comprised only a small portion of their annual sales.
Specifically, the mesh is reported to either migrate out of place or to degrade while in the body. Once the mesh has moved, it impacts the surrounding organs and can cause them to perforate. This causes both bleeding and permanent organ damage. Women can also suffer from intense and continuous pain. Oftentimes, women will require another surgery to remove the mesh that has been inserted. While the damage is rarely fatal, there have been some reported cases of death from transvaginal mesh.
Transvaginal Mesh Failures Years Later
One of the major issues is that once the mesh is in the body it can fail at any time. Women have reported experiencing complications from the mesh years after it was implanted. Even though the use of this mesh has been declining in recent years before it was ordered off the market, there are still new injuries being reported due to the fact that mesh can fail at any time.
When the FDA issued its announcement banning further sales of this product, it did not state that women who have had the mesh implanted should have the mesh removed. Instead, the FDA stated that women should continue to receive annual checkups and follow-up care from their physicians to monitor for signs that the mesh may be failing. However, if women experience symptoms that may indicate mesh failure, they should immediately seek treatment from their physician. The companies are required to continue carrying out postmarket surveillance studies.
Transvaginal Mesh Lawsuit Settlements
Medical expenses from mesh failure can be considerable. Since the pain can be debilitating, it can impact a woman’s ability to work. Thus, lost wages may be a part of any financial compensation to which a woman may be entitled. In addition, pain and suffering and medical expenses may also be recovered from the manufacturer of this product. So far, manufacturers of this product have paid out billions of dollars in jury awards and settlements with those who have suffered injury. These companies have set aside billions of additional dollars to cover future lawsuits that will be brought. For the most part, these device makers are now deciding to settle lawsuits as opposed to fighting them in court. This is typical in large lawsuits where plaintiffs have already won large jury awards in litigated cases.
Defective Medical Device Lawsuits
Medical device makers, in general, can be found to be legally responsible when they sell products in the marketplace that are defective and cause damage to those who receive the devices. As a mesh that is implanted in the body, transvaginal mesh is considered to be a medical device. There are several different theories under which medical device makers can be liable for the damage that their products cause. These include:
- Strict Liability – If the product is found to be defective, the manufacturer is held liable no matter the measures they take.
- Defective Design – There is a problem with the design of the product that makes it dangerous by nature
- Defective Manufacturing – The product is designed properly, but there is an error in manufacturing that causes the product to not work properly
- Negligence – The manufacturer did not exercise the proper level of care in designing and manufacturing the product.
- Improper Marketing – The product is either marketed to the wrong group of buyers or the manufacturer fails to warn of a known issue.
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Women who have received an implant of this transvaginal mesh should continue to be vigilant and on the lookout for possible symptoms of mesh failure. At the first sign of possible trouble, they should consult with an attorney who has experience in helping clients file and litigate claims of this type. The lawyers at KBA Attorneys have a depth of experience in the area of product liability and also in the specific discipline of medical device failure. We can help advise on the merits of the claim and will take the lead in filing and moving it through the legal process. Contact KBA Attorneys to find out how they can help anyone who has been harmed by this mesh receive financial compensation.
Joe Carlson. “After injuries, FDA orders pelvic mesh off the market”, StarTribune, http://www.startribune.com/fda-orders-pelvic-mesh-devices-off-the-market/508652212/. Accessed May 3, 2019.