Atrium Medical

Atrium Medical Corporation is a relatively new medical device manufacturer. It’s based in the U.S., but it sells critical care products worldwide. Atrium is well-known for its soft tissue and hernia repair products. It also makes coronary and peripheral stents and catheters. Atrium operates as a subsidiary of Maquet. Swedish medical technology company Getinge Group owns Maquet.

Atrium Medical Corporation makes popular products like C-QUR mesh. It also makes vascular grafts, local therapeutic infusion catheters and covered stents.

Atrium Medical had stop manufacturing some of these products while it made corrections. Other products were restricted. But people could still get them with a certificate of medical necessity form.

In early 2015, Atrium signed a Consent Decree with the U.S. Food and Drug Administration. The decree established a framework that provided assurances to the FDA that the company would complete necessary improvements to strengthen its quality management system.

In 2018, Atrium faces a growing number of hernia mesh lawsuits. It also recalled 60 units of ProLite Mesh for improper labeling.

About Atrium

Atrium Medical’s headquarters is in Merrimack, New Hampshire. Atrium develops over 2.7 million medical products each year. It distributes them to over 60 countries.

Atrium History

Atrium Medical started in 1981. It has operated as a subsidiary of Maquet Cardiovascular LLC since November 2011, according to Bloomberg.

Maquet has German roots dating back to 1838. Getinge Group acquired Macquet in 2000. Getinge is a Swedish company.

Getinge brought in about $2.6 billion in revenue in 2017. MPO Magazine ranked Getinge No. 25 out of the top 30 medical device companies.

Mattias Perjos is Getinge’s current president and CEO. Carl Bennett is the company’s current chairman.

Atrium Mesh and Other Products

Atrium chest drainage device
Atrium leads the market in chest drainage devices.

Atrium develops products for cardiovascular disease, soft tissue repair and critical care management.

These products include artificial heart components, minimally invasive gastrointestinal devices, various catheters and stents, and soft tissue and hernia repair and support components.

The company also leads the market in chest drainage devices.

Some of Atrium’s popular products include:
C-Qur Mesh
Polypropylene mesh with Omega 3 gel coating
ProLoop Mesh Plug
3-dimensional plug
ProLite Mesh
2-dimensional flexible mesh
Clearway RX
Therapeutic infusion catheter
Xpress-Way RX
Extraction catheter
Cinatra
Drug eluting coronary stent system
iCast
Balloon expandable covered stent
Advanta V12
Balloon expandable PTFE film covered stent
Flixene
3-layer vascular grafts

Atrium Hernia Mesh Lawsuits

Atrium is currently facing hundreds of lawsuits over its popular hernia repair meshes. Injured patients filing the lawsuits claim that the products are defective.

Suffering from complications after hernia mesh surgery? Get a Free Case Review

C-QUR Mesh Lawsuits

Patients injured after being implanted with Atrium’s C-QUR mesh are suing Atrium.

More than 470 C-QUR hernia mesh lawsuits are pending in New Hampshire federal court. Trials are expected to start in 2019.

Atrium C-QUR mesh
Lawsuits blame Atrium C-QUR mesh for serious complications.
Injuries alleged in C-QUR mesh lawsuit include:
  • Chronic inflammation or immune/allergic reactions
  • Infections
  • Adhesions
  • Perforation of surrounding tissues
  • Abdominal pain and bowel obstructions
  • Internal tissue degradation caused by mesh erosion
  • Other injuries caused by mesh failure or migration
  • Second surgeries

ProLoop Polypropylene Mesh Lawsuits

A 2014 lawsuit blamed a man’s injuries on Atrium’s ProLoop polypropylene hernia repair mesh.

Juan Paredes of New Jersey filed the lawsuit against Atrium, Maquet and Getinge Group. He accused the hernia mesh manufacturers of designing a faulty device.

Paredes underwent a double inguinal hernia repair in 2011, according to his complaint. Doctors implanted Paredes with the device during the surgery. He had to have a second surgery in 2012 to have it removed.

The lawsuit claims that possible risks attributed to the Atrium ProLoop mesh include:
  • Shrinking, expanding, cracking and deforming
  • Allergic reactions and chronic inflammation
  • Migration
  • Organ damage
  • Nerve damage
  • Chronic pain
  • Sexual dysfunction

Atrium Settlement

Atrium settled a whistleblower lawsuit in 2016 for $11.5 million.

Esther Grace Sullivan alleged that Atrium paid illegal kickbacks to doctors. He claimed the company paid doctors to promote the company’s iCast brand medical stents for use in patients’ arteries. The FDA had not approved that use.

Sullivan worked for Atrium from 2007 to 2012. He was a sales representative and territory business manager.

Atrium Settlement
The settlement is one of the largest in U.S. history for claims brought under federal law where the government actually declined to join as a party.

Atrium Recalls

Atrium has recalled some of its products, including its problematic meshes. The FDA investigated the problems that initiated each mesh recall and recall of other products as well.

Notable Atrium Recalls
  • 2013
    Product Recalled – C-QUR Edge Mesh (all sizes and shapes)

    Reason for Recall – coated mesh can adhere to inner packaging liner with exposure to high humidity conditions
  • 2015
    Product Recalled – Oasis Dry Suction Water Seal Chest Drain

    Reason for Recall – missing o-ring
  • 2018
    Product Recalled – ProLite Mesh (about 60 units)

    Reason for Recall – improper labeling

Please seek the advice of a medical professional before making health care decisions.

Kristin Compton's background is in legal studies. She worked as a paralegal before joining Drugwatch as a writer and researcher. She was also a member of the National Association of Legal Assistants. A mother and longtime patient, she has firsthand experience of the harmful effects prescription drugs can have on women and their children. Some of her qualifications include:

  • Bachelor of Arts in Legal Studies | Pre-Law from University of West Florida
  • Past employment with The Health Law Firm and Kerrigan, Estess, Rankin, McLeod & Thompson LLC
  • Personal experience battling severe food allergies, asthma and high-risk pregnancies

17 Cited Research Articles

  1. U.S. Food and Drug Administration. (2015, May 7). Class 2 Device Recall Atrium Medical. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135862
  2. U.S. Food and Drug Administration. (2013, July 19). Class 2 Device Recall CQUR Edge Mesh. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119924
  3. Atrium Medical. (2012, April 26). Atrium plans to move headquarters to larger Merrimack, NH facility. Retrieved from http://www.atriummed.com/News/atriumnews.asp?articleid=66&zoneid=1
  4. Juan Paredes vs. Atrium Medical Corporation, et al. (2014, March 5). Complaint and Demand For Jury Trial. Case No. 3:14-cv-00499-DMS-DHB. United States District Court, Southern District of California. Retrieved from https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2014-03-05-Paredes-Complaint.pdf
  5. U.S. Judicial Panel on Multidistrict Litigation. (2018, June 15). MDL Statistics Report – Distribution of Pending MDL Dockets by District. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-June-15-2018.pdf
  6. Fenske, S. et al. (2017, July 26). Top 30 Global Medical Device Companies. MPO Magazine. Retrieved from http://www.mpo-mag.com/heaps/view/3670/1/253218
  7. Getinge. (2016, November 3). Mattias Perjos appointed President and CEO of Getinge Group. Retrieved from https://www.getinge.com/int/about-us/press/news/press-releases/2016/2351997-Mattias-Perjos-appointed-President-and-CEO-of-Getinge/
  8. Getinge. (n.d). Our history. Retrieved from https://www.getinge.com/int/about-us/history/
  9. Getinge. (n.d.). About Us. Retrieved from https://www.getinge.com/int/about-us/
  10. Atrium Maquet Getinge Group. (n.d.). C-Qur Mesh. Retrieved from http://www.atriummed.com/EN/biosurgery/cqur.asp
  11. Atrium Maquet Getinge Group. (n.d.). Our Future. Retrieved from http://www.atriummed.com/EN/About/future.asp
  12. Bloomberg LP. (2018, July 9). Company Overview of Atrium Medical Corporation. Retrieved from https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=6514245
  13. Atrium Maquet Getinge Group. (n.d.). About the Company. Retrieved from http://www.atriummed.com/EN/About/default.asp
  14. Atrium Maquet Getinge Group. (n.d.). Product Status. Retrieved from https://quality-m.maquet.com/customer-support/product/
  15. Atrium Maquet Getinge Group. (n.d.). About the Consent Decree. Retrieved from http://www.atriummed.com/consentdecree/
  16. Maquet Cardiovascular. (2011, November 7). Maquet Cardiovascular Completes Acquisition of Atrium Medical Corporation. PR Newswire. Retrieved from https://www.prnewswire.com/news-releases/maquet-cardiovascular-completes-acquisition-of-atrium-medical-corporation-133359138.html
  17. U.S. Judicial Panel on Multidistrict Litigation. (2018, July 16). MDL Statistics Report – Distribution of Pending MDL Dockets by District. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-July-16-2018.pdf
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