Defective medical devices can make it impossible for a patient to receive the care he or she needs. Medical devices and surgical implants that do not work as they should can compromise patient health, safety, and wellbeing. If you or a loved one has suffered adverse health effects after receiving a hernia mesh implant, contact the New York City personal injury attorneys at Sullivan Papain Block McGrath Coffinas & Cannavo, PC. Our New York city hernia mesh injury attorneys can help you hold a negligent device manufacturer accountable for your damages.
Defective or dangerous hernia mesh devices point to manufacturer liability. Medical device makers use major insurance corporations and legal teams to combat patient injury claims. The best way to level the playing field is by hiring an attorney. A New York hernia mesh injury lawyer will know exactly what type of claim to file, as well as where and when to bring the claim. Your attorney can negotiate aggressively with insurance companies on your behalf, fighting for fair results. You can have peace of mind about your case while your lawyer handles the legwork.
Hernia repair is one of the most common procedures in New York. Unfortunately, the use of hernia mesh to repair the site can lead to further injury. Defective hernia mesh implants have led to lawsuits because of serious injuries and related health complications.
Defective mesh implants may tear, bend, shrink, rip, move, or do other unpredictable things while inside the patient’s body. This can cause serious health consequences, as well as outcomes such as the need for a revision surgery. C.R. Bard, Ethicon (a Johnson &Johnson subsidiary), Atrium, and Covidien, each manufacture products that have caused serious injuries requiring mesh removal.
You might have a hernia mesh injury if you notice any pain around the place of your surgical site, redness or swelling, fever-like symptoms, red streaks around the site, nausea, or continuous constipation. These are common symptoms related to hernia mesh complications.
Most surgical mesh devices are created from coated polypropylene, a low cost petroleum-based plastic. Polypropylene mesh was originally thought to have been more advantageous than traditional sutures in repairing hernias, until dangerous side effects began to be reported. In an attempt to prevent complications, such as adhesions, some manufacturers began producing a bi-layered polypropylene mesh by adding an Omega 3 fatty acid layer. Atrium Medical was the first to add this coating, promoting their C-QUR hernia mesh as being biocompatible. However, there have actually been cases in which the coating prevents incorporation into the body. The coating reportedly tends to peel away from the mesh, causing painful damage to surrounding tissue and infection.
Physicians often place hernia mesh laparoscopically, making defective mesh devices especially dangerous. This type of surgical procedure positions the mesh more deeply into the abdomen, putting other large and important organs such as the bowels, at risk of injury.
Patients who have undergone a procedure to repair a hernia with a coated polypropylene mesh often require surgery to remove the device within one year of implantation.
See a doctor immediately if you notice anything amiss after receiving a hernia mesh implant, such as:
The U.S. Food and Drug Administration (FDA) has received reports regarding hundreds of adverse events in relation to the following manufacturers and their listed devices:
When the above manufacturers put their defective mesh products on the market, they were not required by the FDA to first conduct clinical trials and provide reports on safety and efficacy. This is because the FDA’s 510(k) process permits new mesh products to be sold if they are shown to be similar to other previously approved devices.
In some cases clinical studies would have likely made a difference, especially when companies have received warnings regarding violating standards of safety and effectiveness when it comes to their hernia mesh devices.
In Ethicon’s case, clinical trials for the Physiomesh Flexible Composite Mesh could have prevented the many injuries that have been reported to the FDA, such as adhesions, seromas, hemorrhage, lower tissue integration, mesh migration, and organ perforation. After-market studies conducted indicate a high failure rate of approximately 20 percent for Physiomesh, malfunctioning after an average of six months once implanted. In 2016, Ethicon’s Physiomesh was recalled and it now faces thousands of lawsuits for injuries resulting from the defective mesh.
In 2015, the FDA filed for a permanent injunction against Atrium Medical Corporation’s parent company, Maquet Holding B.V. & Co. KG (Maquet). This came after numerous citations for failing to correct safety violations between 2009 and 2013, despite multiple warnings. Three Maquet manufacturing locations were included in the injunction, including the Hudson, New Hampshire location where Atrium Medical Corporation manufactured C-QUR hernia mesh. The FDA standards violated include:
The FDA cited Atrium for violating 21 C.F.R. § 803.50(a)(1), which entails failing, “to submit an MDR report within 30 days of receiving or otherwise becoming aware of information that reasonably suggested that a marketed device may have caused or contributed to a death or serious injury.”
The permanent injunction was swiftly approved by a federal judge for the District of New Hampshire the day after it was filed. The FDA successfully prohibited the future manufacturing and selling of the C-QUR hernia mesh from Atrium’s facility in Hudson, New Hampshire.
Unfortunately, the injunction was not able to prevent C-QUR mesh from being implanted into patients whose hospitals had already purchased the devices.
Alternatives to hernia mesh include:
Victims of defective hernia mesh implants may be able to file product liability claims against the item’s manufacturer. A successful lawsuit could result in payment for medical bills, pain and suffering, and lost income. Speak to an attorney in New York City about your potential hernia mesh injury claim today.
Sullivan Papain Block McGrath Coffinas & Cannavo, PC has experience handling these types of claims, and can let you know if you have grounds for a lawsuit after listening to your story. Begin the process toward obtaining compensation today. Schedule a free consultation through our online portal or by calling (212) 732-9000.