Several types of hernia mesh have been recalled, and manufacturers voluntarily pulled others from the market after patients reported adverse events and complications. The U.S. Food and Drug Administration (FDA) is in charge of approving medications and medical devices for the U.S. market. When a product poses harm, does not include adequate warnings, or there are other issues, they can take action.
In the case of implantable hernia mesh patches, the FDA saw a pattern of serious complications, many of which required additional surgical procedures. Between 2013 and 2018, they recalled several types of these surgical mesh products. Despite the recalls, some people who underwent mesh hernia repair continue to report complications.
Today, the most common type of hernia repair procedure uses a synthetic mesh patch to close the hernia. This offers a more reliable repair since the surgery does not count on the tissues that opened the first time to stand up to the pressure of being stitched closed. However, any time you implant a foreign material in the body, there can be complications. And in the case of hernia mesh patches, complications are common.
Despite previous warnings from the FDA and thousands of adverse events reported, manufacturers continued — and continue today — to market mesh hernia implants. While many remain on the market, manufacturers and the FDA recalled some with the worst reputations. These include:
C.R. Bard and Davol recall the first lots of Composix Kugel. There are additional recalls of this product during the next two years, as well. Since that time, there have been reports that they knew of the dangers of polypropylene resin hernia mesh patches as early as 1997.
Johnson & Johnson and Ethicon recall some of their Proceed surgical mesh products.
The FDA issues recall of Atrium Medical Corporation’s C-QuR V-pack Mesh.
Johnson & Johnson and Ethicon voluntarily recall all their Physiomesh Flexible Composite Mesh products.
The FDA recalls some ProLite Mesh products made by Atrium Medical Corporation.
The FDA issues a recall for Versatex Monofilament Mesh made by Sofradim Production.
Covidien LLC issues a voluntary recall of its Parietex Composite Parastomal Mesh.
If you suffered serious complications related to a hernia mesh implant, you might be eligible to take legal action against the mesh manufacturer. This is true, no matter if there was a recall on the mesh used in your surgery or not. Let the Zanes Law team review your case, identify the mesh used in your procedure, and explain your legal options.
Some of the most common symptoms and complications related to a mesh patch hernia repair include:
Many of these complications require revision surgery, attempted removal of the hernia mesh patch, or another operation to repair the hernia. In many cases, these secondary procedures are much more extensive and invasive than the original hernia repair surgery.
At Zanes Law, our hernia mesh lawsuit attorneys will review your case at no cost to you. If you suffered pain, infection, or other complications, if your surgeon implanted recalled mesh, or if you underwent revision surgery, we can build a solid case on your behalf. Our team knows what it takes to win dangerous and defective medical device cases.
We will request your relevant medical records and medical evidence and identify the mesh implant used in your procedure. With the product code or name, we can determine if there was a medical device recall on your patch. We may be able to join a mass tort already in progress or pursue our own case against the mesh manufacturer, no matter if there was a recall or not.
Call 866-499-8989 today. We can sign you up over the phone during your free consultation.