Atrium Prolite & C-Qur Hernia Mesh Lawsuits
A growing number of plaintiffs are pursuing product liability lawsuits against Atrium Medical Corporation after experiencing catastrophic harm from the company’s hernia mesh products. At present, Atrium mesh lawsuits have been filed in Florida, Louisiana,Texas and New Hampshire – site of Atrium Medical’s headquarters.
Just like the vaginal mesh inserts used to treat pelvic organ prolapse and urinary incontinence, hernia mesh has been linked to high failure rates and life-altering injuries, which victims claim are a direct result of design and manufacturing defects.
Amid the escalating concern about hernia mesh safety and rising numbers of adverse event reports, The Bonsignore Trial Lawyers are offering confidential case reviews for those who suffered serious complications from the C-Qur Mesh and Prolite mesh devices.
Atrium C-Qur hernia mesh allegations
Atrium launched its C-Qur mesh in 2005, via the 510(k) FDA premarket process, which allows new medical devices deemed similar to existing ones to enter the marketplace without the benefit of stringent safety trials. The C-Qur product combines polypropylene mesh with a proprietary Omega 3 gel covering (known as the O3FA coating), containing Omega3 fatty acids and triglycerides.
Despite this new, advanced design, a number of hernia repair patients began reporting significant health problems following implantation with the C-Qur mesh, including life-threatening infections and internal injuries requiring hospitalization. According to a recent hernia mesh lawsuit brought by a Louisiana man, the Atrium C-Qur mesh adhered to his small bowel, twisting the organ and causing gangrene.
His complaint leveled serious accusations that the “ defendant has known that the C-Qur mesh products had high failure and complication rates, resulting in the recall of some of these mesh products… and are causing numerous patients severe injuries and complications.”
Other allegations common in Atrium mesh claims :
- Defendant misrepresented the safety of its products to the medical community, FDA and the public
- The product had known design defects causing immune system reactions and tissue breakdown
- Defendant underreported and withheld information about the product’s propensity for failure and injury
- Defendant actively and intentionally misled the public about high risk of Atrium C-Qur mesh complications
- Defendant failed to perform adequate safety tests on the product
- Defendant provided insufficient and misleading training to doctors, in order to increase the number of physicians using C-QUR Mesh Products
- C-QUR Mesh Products were manufactured and designed negligently
- Defendant failed to adequately warn about the heightened risks of erosion, premature degradation and permanent injury
Plaintiffs who sustained injury from Atrium mesh products are suing on counts of strict liability, gross negligence, unjust enrichment, failure to warn, constructive fraud, breach of warranties and negligent misrepresentation.
Hernia mesh complications & injuries
C-Qur mesh, since its introduction more than 10 years ago, has shown poor performance among hernia repair patients. Several studies and more than 1,000 adverse event reports gathered by the FDA show that Atrium hernia mesh was associated with more complications and disproportionately high failures compared to other products.
Touted as a safe, minimally-invasive treatment for chest wall reconstruction and hernia repair, C-Qur mesh has been linked to the following complications:
- Allergic reactions
- Chronic abdominal pain
- Gastric ulcers
- Mesh migration
- Organ perforation and bowel damage
- Mesh erosion
- Neuromuscular complications
- Mesh adhesion
- Recurrence of hernia
- Need for revision surgery
The Bonsignore Trial Lawyers have the knowledge, resources and litigation experience to help those who have been affected by faulty medical devices, such as hernia mesh. If you or someone you love has endured severe health problems brought on by Atrium C-Qur or Prolite mesh, we will review the merits of your case and determine if legal action is warranted.
Hernia mesh repair products by Atrium
Over the years, Atrium Medical has introduced several hernia repair mesh devices– made with the same polymer plastic and O3FA coating as the C-Qur mesh – despite an influx of adverse reports involving infections, adhesions and organ damage. This line includes:
- Atrium C-Qur V-PATCH
- Atrium C-Qur FX MESH
- Atrium C-Qur Mosaic
- Atrium C-Qur TacShield
- Atrium C-Qur CentriFX
Compensation sought by plaintiffs
Litigation against Atrium centers on claims of defects within the triglyceride coating material that triggers tissue breakdown, adverse reaction and lasting injury. When manufacturers value their bottom line more than public safety, it’s usually the consumer who pays the ultimate price. Fortunately, product liability laws protect the rights of those who have been harmed by gross negligence in the design, production and marketing of medical devices, enabling plaintiffs to seek restitution.
Monetary damages available in a hernia mesh lawsuit include those for:
- Past, present and future medical costs
- Loss of income
- Pain and emotional suffering
- Loss of enjoyment in life
- Loss of spousal consortium
- Loss of earning capacity
- Legal costs
FDA warnings & C-Qur mesh recall
Between the period of 2009 and 2013, FDA officials conducted inspections across several Maquet (parent company of Atrium) facilities, discovering multiple violations of the quality system regulation, medical device reporting regulation, and Correction and Removal (CR) regulation. Regulators issued two warning letters, citing Atrium for failing to maintain sterile environs during manufacturing and failing to employ proper protocol for complaints regarding C-Qur mesh infections.
A voluntary Atrium C-Qur mesh recall was issued in 2013, when it was found that the mesh coating could adhere to package lining when exposed to high amounts of humidity. Although labeled a Class II recall, none of the hernia mesh products were removed from the marketplace.
Hernia mesh lawyers
For more than 30 years, The Bonsignore Trial Lawyers have been focused on consumer protection from dangerous and defective medical devices. Unlike smaller, inexperienced firms, we leverage the financial means and highly-credentialed staff to formulate sound legal strategies that hold negligent manufacturers liable for their actions.
A free consult with a hernia mesh attorney can shed light on the potential value of your claim, and the nuances of Atrium hernia mesh litigation. Call toll-free at 1-866-600-3890 to schedule yours today!
Atrium hernia mesh resources
- FDA, Class 2 Device Recall CQUR Edge Mesh http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=119924
- British Journal of Surgery, Degradation of mesh coatings and intraperitoneal adhesion formation in an experimental model https://www.ncbi.nlm.nih.gov/pubmed/19224521#
- AtriumMed, C-QUR™ MESH http://www.atriummed.com/en/biosurgery/cqur.asp
- AtriumMed, Prolite MESH http://www.atriummed.com/en/biosurgery/prolite.asp