What is Strattice™?
Strattice Reconstructive Tissue Matrix (RTM) is a surgical mesh device that is made from porcine dermis (pig skin) to help with soft tissue repair. This mesh is primarily used in surgical repairs of damaged or ruptured soft tissues, typically in the repair of hernias or body wall defects. When soft tissue inside our bodies become weak or damaged, it requires reinforcement or bridging of materials during surgery. That is where surgical mesh comes into play. For hernia repairs or surgeries of this nature, surgical mesh has generally replaced sutures or stitches.
There are multiple Strattice products that could have been used in your surgical repair – Strattice RTM, Perforated, Extra Thick, or Laparoscopic. Each product is a type of surgical mesh and can be the cause of complications after implantation. Strattice mesh is manufactured by Allergan, Inc. and LifeCell Corp., and is advertised to be strong, effective and biologically integrative. However, this may not always be the case.
From product recalls to post-implantation injuries, Strattice mesh may be the cause of your pain and you could be compensated for it. Read below for more information about FDA recalls and common complications or symptoms that can result from faulty Strattice mesh.
Has Strattice™ been recalled or been involved in any legal proceedings?
The Food and Drug Administration (FDA) issued a recall of Strattice Reconstructive Tissue Matrix (RTM) products in 2010 and again in 2011. In 2010, Strattice was issued a Class III Device Recall, it was recalled for mislabeling. Subsequently in 2011, Strattice was issued a Class II Device Recall. Strattice was on this product recall because it had not been cleared for usage specifically in stoma reinforcement. This particular recall terminated in 2013. In addition to these recalls, LifeCell, manufacturer of Strattice™, has been under fire for several warning letters from the FDA, the most recent one being in 2015 for a different product.
The FDA has a mandatory and voluntary reporting system for adverse events or outcomes from the use of medical devices. Mandatory reporters include manufacturers, importers and device user facilities; voluntary reporters include health care professionals, patients and consumers. These Adverse Event Reports are housed in the MAUDE (Manufacturer and User Facility Device Experience) database and are a way for the FDA to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. Although the system only provides data on the past ten years and has some limitations, it ultimately is a valuable source of information. In the last ten years, Strattice has had 431 Adverse Event Reports submitted; these Reports range from resurgence of hernias to product malfunctions, such as tearing, that could and did lead to serious injuries. These Reports are available for public access and are an important to consider when looking into the various injuries and complications that can result from a Strattice implant.
In 2018, the Strattice product was involved in a proceeding alongside other Hernia Mesh products such as the Composix Kugel Hernia Patch and the Bard Ventralight Elipse mesh. Evelyn Menjivar filed a complaint in the U.S. District Court for the Eastern District of New York claiming that these mesh products were defective and sold without adequate warnings about the risk that they may cause certain complications. Ms. Menjivar underwent several surgeries where these mesh products were implanted, yet she experienced product failures and adverse events because of it, including scarring, adhesions and chronic abdominal pain. Although these mesh products such as Strattice marketed themselves as “safe, effective, and reliable medical device[s],” these products caused more pain than healing. The complaint itself states that the “defendants failed to perform proper and adequate testing and research in order to determine and evaluate the risks and benefits of the Hernia Mesh Products.” Ms. Menjivar’s experience is one of many, but she was able to go forth and pursue a lawsuit against the manufacturers who caused her such pain.
If you or someone you love has had a Strattice implantation and is experiencing pain or continual complications, they may be experiencing injuries as a result of the Strattice mesh device.
Complications from a Strattice™ implant?
How Can We Help You?
If you or someone you love have, or plan to, undergo revision surgery to remove or replace your hernia mesh after experiencing severe injuries or complications, contact us today to further evaluate your rights to compensation.
Here at Van Wey, Metzler & Williams, we have more than 100 combined years of experience fighting against a healthcare industry that seems to put profits over patients. This includes doctors, hospitals, and the manufacturers of medical devices. Strattice implants that have been recalled by the FDA are subject to suit to repay you for your injuries including lost wages, medical expenses, or even funeral costs.
If you or someone you love was implanted with a recalled Strattice mesh device that required revision surgery, please call us or submit your case for evaluation today.
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