There are various types of hernia mesh products designed and manufactured by many manufacturers, and Atrium Medical Corp. is one of them. Many patients of Atrium mesh, however, claim the devices have caused injuries, including infection, bowel obstruction, mesh migration, and -- among other complications -- mesh failure.
Personal injury attorneys at Shouse Law Group want to make sure you understand the products used in your hernia repair surgery. Here, we answer common questions related to Atrium Medical Corp. and its hernia mesh product line.
- 1. What is Atrium Medical Corp.?
- 2. What hernia products does Atrium manufacture?
- 3. What are specific problems associated with some Atrium hernia mesh products?
- 4. Which Atrium products have been subjected to recalls?
- 5. What compensation is available to you if you have been injured by an Atrium hernia implant?
- 6. When should you seek legal counsel to file a claim against Atrium?
Atrium was founded in 1981 as a healthcare provider. Since 2006, it has become a prominent developer and manufacturer of hernia mesh products available in the United States.
Atrium currently manufactures ten different types of hernia mesh products. These include the C-QUR line as well as a few other products.
- C-QUR MOSAIC is produced as flat sheets made of polypropylene and coated with omega 3 fatty acids.
- Vitamesh is a macroporous condensed netting made out of polypropylene.
- C-QUR TACSHIELD is reinforced mesh made of polypropylene monofilament and coated with omega 3 fatty acids.
- C-QUR V-PATCH is reinforced patch also made of polypropylene monofilament and coated with omega 3 fatty acids.
- C-QUR MESH is a flat sheet made of polypropylene monofilament and coated with omega 3 fatty acids.
- C-QUR CENTRIFX is a laparoscopic pre-shape polypropylene monofilament mesh coated with omega 3 fatty acids.
- C-QUR FX is a flat sheet of polypropylene monofilament coated with omega 3 fatty acids.
- PROLOOP is a 3D mesh plug made of polypropylene monofilament.
- PROLITE is a flat sheet made of polypropylene monofilament.
- PROLITE ULTRA is another flat sheet made of polypropylene monofilament. 1
Atrium's C-QUR line has been the subject of many lawsuits. As you can see above, most of Atrium's hernia implant products are made of polypropylene and are coated with omega 3 fatty acids. These two substances are the source of the problems associated with these devices.
Polypropylene is a type of plastic that has been around for a long time. It is used in hernia mesh products for its strength and affordability. In other words, it is extremely cheap, especially when compared to other materials or substances. And its cheapness is also a reason it continues to be used in light of its known dangers. Polypropylene is a very heavy product, “far greater than what is required physiologically.” 2 When the polypropylene is not coated, the plastic has a high rate of causing an “intense inflammatory response that lead to side effects and complications.” 3
Polypropylene also has a high rate of shrinkage (30 to 50%). 4 The substance is known to deteriorate. 5 Doctors are well aware of the shrinkage nature of polypropylene and attempt to calculate the necessary size so that they achieve the right fit. A patient's response to the implant will vary according to
- Filament size
- Pore size
- Individual response of each carrier.
If a patient's body responds adversely, the consequences can be mild to severe:
To address these known disadvantages of polypropylene, lighter polypropylene mesh has been designed and manufactured. There are, however, no studies that account for their safety and efficacy. Another method used to address the problems associated with polypropylene is the use of coatings or composite mesh. Coatings, however, are accompanied by their own problems.
Omega 3 fatty acids are derived from fish sources. It is used as a coating in most Atrium hernia mesh products, especially those made of polypropylene. The omega 3 fatty acids is derived from fish oil, and many patients have a severe reaction to the substance. 7 When a patient has an allergic reaction, it can lead to further complications, like infection and bowel obstruction.8
Atrium C-QUR V-Patch mesh product (all sizes and shapes) was the subject of a 2013 Class II Device Recall by the U.S. Food and Drug Administration (FDA). 9 The FDA cited the company for failure to package the product properly: high humidity can cause the coated mesh to adhere to the inner packaging liner.
But the packaging of the C-QUR V-Patch is not the only problem associated with the C-QUR V-Patch or other C-QUR products. Lawsuits have been filed against the company for:
- Ignoring multiple sterility complaints (e.g., human hair was found inside the mesh plants);
- Failing to comply with safety standards when designing and manufacturing the products;
- Failing to warn physicians, medical professionals, and patients about the potential for injury; and
- Marketing a defective medical device.
If you have been injured by a defective Atrium hernia mesh product, you may qualify for compensation. Compensation is meant to reimburse you for all economic damages and non-economic damages you incurred. Several thousand lawsuits have already been settled where injured plaintiffs have been compensated and thousands more are either pending or being filed.
If you or a loved one have suffered serious complications due to an Atrium mesh product, you should seek legal counsel immediately. Time is of the essence due to the statute of limitations, which can vary depending on the state or jurisdiction your lawsuit -- if applicable -- could be filed.
We are currently taking hernia mesh cases now. We have offices locally throughout California but accept these types of cases throughout the United States. Call our office today at (855) 396-0370 or complete our online form. We will review your case and your options with you.
- Atrium Medical. Atrium Biosurgery.
- Elango, Perumalsamy, Ramachandran, Vadodaria. Mesh materials and hernia repair. Biomedicine (Taipei). 2017 Sep; 7(3): 16. doi: 10.1051/bmdcn/2017070316.
- Gil, Rex, Reukov, Vertegel. In vitro study on the deterioration of polypropylene hernia repair meshes. J. Biomedical Material Research. 2017 October. Doi: 10.1002/jbm.b.34029.
- Supra note 2.
- Kong, Lai, Khoo, Rahman, Chin. Inflammatory reaction to fish oil coated polypropylene mesh used for laparoscopic incisional hernia repair: a case report. BMC Surg. 2016; 16: 8. doi: 10.1186/s12893-016-0123-8.
- FDA. Class 2 Device Recall. Recall Event ID 65698.