Atrium ProLite & ProLoop Hernia Mesh Lawsuits | 2026 Latest Updates

Plaintiffs allege that defects in Atrium ProLite, ProLite Ultra and ProLoop hernia mesh caused them serious complications and injury. The mesh was made by Atrium Medical Corporation, and Maquet Cardiovascular, LLC is also a defendant. The cases are individual product liability lawsuits in federal courts. One earlier case, Africano, filed in 2017 in an Illinois federal court, was tried to a defense verdict. The FDA cleared the mesh in August 2015. On April 5, 2022, a federal Judicial Panel on Multidistrict Litigation denied centralization of the cases, so no MDL has been formed.

Latest Atrium ProLite and ProLoop Hernia Mesh Lawsuit Updates

April 5, 2022: JPML Denies Centralization of the ProLite and ProLoop Cases

The Judicial Panel on Multidistrict Litigation (JPML) denied a motion to centralize the ProLite and ProLoop cases as MDL No. 3024. The Panel wrote that centralization “is not necessary for the convenience of the parties and witnesses” [1]. Ten actions were before the Panel: four in four districts on the motion and six related actions in six districts.

December 10, 2021: Motion to Centralize the Cases Reaches the JPML

The JPML opened its docket for MDL No. 3024 [2]. Plaintiffs in two actions, Avila and Kolbeck, asked that the cases be centralized in federal court in California. Both defendants opposed the request. Schedule A of the JPML order lists the four actions on the motion. They are Avila (No. 2:21-05223), Mills (No. 2:17-12624), Aguirre (No. 2:18-00153) and Kolbeck (No. 3:21-00776).

October 19, 2021: Africano Case Is Terminated

Africano v. Atrium Medical Corporation (No. 1:17-cv-07238) was terminated on this date [3]. The case is a product liability action in the Northern District of Illinois. The JPML later wrote in its April 5, 2022 order that this ProLite case had been tried to a defense verdict.

February 23, 2018: FDA Posts a Class 2 Recall of ProLite Mesh

The FDA posted a Class 2 recall of ProLite Mesh, Recall Number Z-0712-2018, in its recall database [4]. Atrium Medical Corporation had started it on November 22, 2017. The recall began because an incorrect ProLite Mesh configuration was packaged in pouches labeled for another product code. The recall covered 60 units sent to Spain only and ended on July 30, 2018.

October 6, 2017: Africano Complaint Is Filed in Illinois

Randy J. Africano and Diane Africano filed their complaint against Atrium Medical Corporation on this date. It was a diversity case in the same Illinois federal court, and the complaint included a jury demand. The JPML later described Africano as a ProLite action and wrote that the litigation has been ongoing since at least 2017.

August 27, 2015: FDA Clears ProLite and ProLoop Mesh Under 510(k)

The FDA cleared ProLite Mesh, ProLite Ultra Mesh and ProLoop Mesh Plug as “Substantially Equivalent” under 510(k) K151437 on August 27, 2015 [5]. Atrium Medical Corporation submitted the notice on May 29, 2015. The FDA lists the device type as “Mesh, Surgical, Polymeric,” product code FTL.

What Is Hernia Mesh?

According to the FDA, surgical mesh is a medical device. It gives extra support to weakened or damaged tissue. Most mesh devices now available are made from synthetic materials or animal tissue [6]. Surgeons often use mesh in hernia repair. It strengthens the repair and reduces the rate of the hernia happening again. Counsel told the JPML that ProLite and ProLoop mesh both use polypropylene.

Who May Be Affected?

The lawsuits describe people who had Atrium ProLite, ProLite Ultra or ProLoop mesh implanted, for example in a hernia repair. These people later had complications. The FDA’s recall record describes ProLite Mesh as intended for use in “soft tissue deficiencies including hernia repair.” The FDA’s hernia mesh page says non-absorbable mesh remains in the body indefinitely but may undergo some degradation over time. Whether any one person qualifies depends on individual facts, so each case needs its own legal review. Cases over other hernia mesh brands are covered on our hernia mesh patch lawsuits page.

Reported Injuries or Damages

Plaintiffs in the ProLite and ProLoop actions allege that defects in the mesh caused them to suffer serious complications and injury. The JPML order names no specific injuries. It makes no finding. The FDA’s hernia mesh page lists the most common adverse events for all hernia repairs, with or without mesh. They are pain, infection, hernia recurrence, adhesion, obstruction, bleeding, fistula, seroma and perforation. For repairs with mesh, the FDA adds migration or shrinkage of the mesh itself. This list is not specific to ProLite or ProLoop. Cunningham and colleagues reviewed mesh migration after abdominal hernia repair [7]. Their review, in the journal Hernia, was first published January 30, 2019. Implicated materials included polypropylene, PTFE and composite mesh. The authors called for standardized reporting. A BMJ news item by Jacqui Wise, published September 27, 2018, reported a BBC investigation of hernia mesh in England [8]. The BBC investigation found that up to 170,000 patients who had hernia mesh operations in England in the past six years could be experiencing complications. The estimate rests on surgeons’ view of the complication rate. The item concerns hernia mesh in general and does not name Atrium products.

Recall and Regulatory Background

The FDA record for the ProLite recall describes a packaging mix-up. It does not describe an injury or a design finding. No FDA device recall record names ProLoop mesh. Litigation over Atrium’s C-Qur mesh is covered on our Atrium C-Qur hernia mesh litigation page.

Evidence to Preserve

Keep records that show which mesh was used, when it was implanted and what followed after the surgery:

• Hospital implant records or the operative report naming the mesh (ProLite, ProLite Ultra or ProLoop) and its lot or catalog number
• Implant stickers or labels that came with the mesh, kept with your surgery and discharge records
• Later medical records, imaging and doctor’s notes about complications or any repeat surgery
• Bills and insurance papers for the surgery and for the treatment of any complications
• Photographs of any visible effects, with the date each one was taken
• A dated journal of your symptoms, written as they happen or change
• Letters, emails and messages with the surgeon, hospital or manufacturer about the mesh

Filing Deadlines

Deadlines to file a claim over a medical device injury come from state law, so the rules differ with where you live. The time limits also depend on when the injury happened and was diagnosed. Missing a deadline can end a claim even when the facts are strong, so anyone thinking about a claim should check with a lawyer promptly.

Frequently Asked Questions

What Do the Atrium ProLite and ProLoop Hernia Mesh Lawsuits Allege?

The Atrium ProLite and ProLoop hernia mesh lawsuits allege that defects in the mesh can lead to various and serious complications. The JPML recorded that no party disputed that the actions share those allegations. The Panel made no finding on the merits.

How Are ProLite, ProLoop, and C-Qur Mesh Different?

ProLite and ProLoop mesh differ from C-Qur mesh, a separate Atrium mesh line. Counsel told the JPML at oral argument that the ProLite and ProLoop designs “are not identical,” and no party argued that claims against the two products involve substantially different questions of fact.

Have Atrium ProLite or ProLoop Hernia Mesh Products Been Recalled?

The FDA lists one recall of Atrium ProLite hernia mesh, a Class 2 recall covering ProLite Mesh lot number 412298. ProLoop mesh has not been part of an FDA device recall.

What Does the Research Say About Hernia Mesh Complications?

Research on hernia mesh complications includes an FDA analysis and a mesh migration review. The FDA says as many as one million hernia repairs take place each year in the U.S. The Cunningham review of 84 articles found that migration commonly affected multiple organs.

What Should I Do If I Have Complications from Atrium Hernia Mesh?

If you have complications from Atrium hernia mesh, the FDA says to talk to your surgeon about your specific circumstances and your best options. The FDA also gives instructions for reporting problems with mesh to the agency.

Why Were the ProLite and ProLoop Cases Not Combined into One Proceeding?

The ProLite and ProLoop cases were not combined because the Panel said alternatives were available, “including informal cooperation and coordination of these actions.” It also noted that two actions had been pending in federal court for roughly four years.

References

1. https://www.jpml.uscourts.gov/sites/jpml/files/MDL-3024-Order%20Denying%20Transfer-3-22.pdf
2. https://www.courtlistener.com/docket/63242409/in-re-atrium-medical-corporation-prolite-and-proloop-hernia-mesh-products/
3. https://www.courtlistener.com/docket/6653379/africano-v-atrium-medical-corporation/
4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161830
5. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151437
6. https://www.fda.gov/medical-devices/implants-and-prosthetics/hernia-surgical-mesh-implants
7. https://pubmed.ncbi.nlm.nih.gov/30701369/
8. https://www.bmj.com/content/362/bmj.k4104.full