Laparoscopic Hernia Repair Surgery Kugel Patch Lawsuit | 2026 Latest Updates

The Bard Composix Kugel Mesh Patch, made by Davol Inc., a subsidiary of C. R. Bard, Inc., was recalled in a Class 1 recall. The maker said its memory recoil ring could break and potentially cause a bowel perforation. Injury lawsuits over the patch were consolidated as MDL 07-1842 in the District of Rhode Island. The litigation ended in settlement. The FDA lists the recall status as Completed. The patch repairs ventral (incisional) hernias. The recall began in December 2005 and later covered the X-Large oval, midline oval and older large sizes. A 2024 Rhode Island Supreme Court order concerned legal fees between attorneys and was not a new injury case.

Latest Laparoscopic Hernia Repair Surgery Kugel Patch Lawsuit Updates

July 9, 2024: Rhode Island Supreme Court Rules on Legal Fees

The Rhode Island Supreme Court issued an order in In re Kugel Patch, No. 2020-285, in a dispute between attorneys over legal fees. The suits were personal-injury lawsuits against the makers of a hernia repair patch [1]. The order notes that a global settlement of the Kugel Mesh claims was reached in Rhode Island Superior Court in 2014. It is not a new injury case.

June 18, 2013: Court Grants Summary Judgment for One Plaintiff

Chief Judge Mary M. Lisi of the District of Rhode Island granted summary judgment to the defendants. It applied to plaintiff Jeri Burger (CA 08-2301ML) in the Kugel mesh MDL [2]. The ruling granted a motion filed by the defendants, Davol Inc. and C. R. Bard, Inc. It covered that one plaintiff in the litigation.

May 29, 2013: University Reports $200 Million Settlement

The University of Rhode Island reported that the 2,000 individuals injured by the Kugel Mesh Hernia Patch received a $200 million settlement. The manufacturer paid it [3]. The same article described a court review of the plaintiffs’ lawyers’ $1.74 million in expense claims, cut by 5.6 percent, which returned $97,000 to injured parties.

April 3, 2006: Recall Expands to More Sizes

The FDA and Davol expanded the Class 1 recall of the patch, Medscape reported [4]. It covered all lots of the oval “midline” size. It also covered older large lots made before 2004. Surgeons and hospitals were told to stop using the affected lots and to return unused units to the company.

February 22, 2006: FDA Posts the Recall Record

The FDA posted the recall of the X-Large patch as a Class 1 action [5]. The recalling firm is listed as Davol, Inc., Sub. C. R. Bard, Inc. The record covers 31,761 units under recall numbers Z-0524-06 and Z-0526-06. It gives the recall reason as a memory recoil ring that could break.

December 22, 2005: Davol Starts the Recall

Davol Inc. initiated a recall of the Bard Composix Kugel Mesh X-Large Patch on December 22, 2005 [6]. It notified U.S. customers by letter on December 27, 2005. The X-Large oval size was the first patch recalled, and later steps widened the recall to the midline oval and older large sizes.

What Is a Kugel Patch?

According to the FDA patient page, most hernia repair surgeries include the use of implanted surgical mesh. A patient can ask the surgeon for the maker, brand name, Unique Device Identifier (UDI) and material of the mesh [7]. Medscape reports that this patch is indicated for the repair of ventral (incisional) hernias. Its memory recoil ring lets it spring open and lie flat behind the defect. It is folded for insertion through a small incision.

Who May Be Affected?

You may be affected if you had a Bard Composix Kugel Mesh Patch implanted. The recalled sizes are the X-Large oval (code 0010208), the midline oval (0010209), and the large oval (0010202) and large circle (0010204) made before 2004. For the X-Large oval, the recall covers lots with M, N, O or P as the fourth character of the lot number. If the lot number has none of those letters, the lot is not affected. The FDA record lists lot codes from 41XMXXXX to 43XPXXXX for the X-Large size. Whether a legal claim remains depends on your own facts, and only an individual legal review can say.

Reported Injuries or Damages

The recall reason was ring breakage. The manufacturer said it could lead to bowel perforation or chronic enteric fistula. That is the maker’s statement of the hazard and not a court finding. Medscape reported in April 2006 that patients with a recalled device should seek immediate medical attention. The symptoms it named were unexplained or persistent abdominal pain, fever and tenderness at the implant site, plus other unusual symptoms. A retrospective study by Dasari, Grant and Irwin at the Royal Victoria Hospital in Belfast covered 219 patients treated from 1996 to 2006. Of these, 92 had Lichtenstein repair and 127 had a Kugel patch [8]. Recurrence was 1.1% after Lichtenstein repair and 6.3% after Kugel patch repair. Severe chronic groin pain was reported by 1.6% of Kugel patch patients and by none in the Lichtenstein group.

Recall and Regulatory Background

The Davol recall belongs to FDA recall event 34393. A recall does not by itself establish liability. Medscape gave Davol’s 2006 contact details as 1-800-FOR-BARD (1-800-367-2273) and bard.helpline@crbard.com. For other hernia mesh products, see our hernia mesh patch lawsuit page.

Evidence to Preserve

Keep these records, because they may show which patch you received and what harm followed:

• Operative or discharge records that name the implant, which the surgeon or hospital can provide.
• The implant card or product label showing the lot number, to compare with the recalled lots.
• Medical records of pain, fever, imaging or any revision surgery after the implant.
• Photographs of the implant site and any visible effects over time.
• Purchase and billing records from the hospital, surgeon or surgery center for the operation.
• Communications with the hospital, surgeon or manufacturer, including letters, emails and call notes.

Filing Deadlines

Filing deadlines for injury claims are written into state law, and where you live decides which rule applies to your claim. The timing also depends on when the injury happened and when it was diagnosed, so two patients can face different dates. If a Kugel patch problem appeared long after surgery, the time limit may already be running. A lawyer can check the dates that apply to you.

Frequently Asked Questions

How Do I Know If My Hernia Mesh Is Torn Years Later?

You cannot tell that hernia mesh is torn years later from one sign. The FDA tells patients to know the symptoms of hernia recurrence and when to seek evaluation, and to keep the mesh brand and UDI.

What Does the Research Say About Kugel Patch Repair?

The research on Kugel patch repair includes a Belfast study of Lichtenstein and Kugel patch operations for inguinal hernia repair. Its authors wrote that recurrence and chronic groin pain were higher with Kugel repair, but this was not statistically significant (p = 0.09).

Where Can I Report a Kugel Patch Problem?

You can report a Kugel patch problem to FDA MedWatch at 1-800-FDA-1088, the number Medscape listed for adverse events in the 2006 recall report. Davol’s 2006 helpline took questions about the recall.

Was the Kugel Patch Recall Limited to the United States?

The Kugel patch recall was not limited to the United States. The FDA recall record lists distribution nationwide and in Australia, Canada and Japan. That distribution is listed for the X-Large size.

References

1. https://www.courts.ri.gov/Published%20Orders/Supreme-20-285.pdf
2. https://www.govinfo.gov/app/details/USCOURTS-rid-1_07-md-01842/USCOURTS-rid-1_07-md-01842-14
3. https://www.uri.edu/news/2013/05/graduate-students-review-legal-expense-claims-in-nationwide-kugel-mesh-product-liability-litigation-97000-r
4. https://www.medscape.com/viewarticle/529032
5. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43767
6. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43769
7. https://www.fda.gov/medical-devices/surgical-mesh-used-hernia-repair/surgical-mesh-used-hernia-repair-information-patients
8. https://pmc.ncbi.nlm.nih.gov/articles/PMC2699199