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Case guide

Hernia Mesh Recalls: Check the Exact Notice

Check the exact mesh and the notice that applies to it. A recall does not always mean the implant needs to come out or that you will get money.

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Free · No obligation · About 2 minutes

Updated Oct 4, 202618 sources

This may apply to you if

  • Identify the maker, model and date of your mesh implant.
  • Gather the diagnosed problem and treatment history for legal review.
  • Tell the lawyer about any prior case, offer, release or agreement.

What the public record says

These are cited sources. Their inclusion does not imply that they endorse People’s Justice or reviewed this page.

Michael J. Rosen · Department of Surgery, Center for Abdominal Core Health, Cleveland Clinic Foundation, Ohio · First-listed author of the randomized mesh trial

Finding: The 253-person trial found fewer returning hernias with synthetic mesh than with biologic mesh at two years in the studied repair. It found no significant difference in wound events requiring a procedure. The study does not describe every material, placement or rare severe complication.

Rosen original randomized hernia mesh trial, 2022 (opens in a new tab) · Jan 19, 2022 · Checked Oct 3, 2026

Therapeutic Goods Administration · Therapeutic Goods Administration, Australia · Australian medical-device regulator

Finding: The June 9, 2016 notice concerns the laparoscopic Physiomesh product and unused stock. It excludes the Open version and leaves patient care to the treating professional.

Australian TGA Physiomesh hazard alert, June9,2016 (opens in a new tab) · Jun 9, 2016 · Checked Oct 3, 2026

The evidence and its limits

Cleveland Clinic Foundation and four other specialized US medical centers · JAMA Surgery · 2022

Biologic vs synthetic mesh in contaminated ventral hernia repair

Design:
Randomized controlled trial
Participants:
253 adults: 126 assigned synthetic mesh, 127 assigned biologic mesh
Finding:
Synthetic mesh reduced two-year hernia recurrence compared with biologic mesh. No significant difference was found in wound events requiring a procedure.
Main limitation
Two materials and one placement in specific repairs at specialist centers; two-year follow-up cannot describe all models or rare severe harms. Some authors disclosed industry relationships.

Read the source: Biologic vs synthetic mesh in contaminated ventral hernia repair (opens in a new tab) · Checked Oct 3, 2026

The short answer

How should I check whether a notice applies?
Match the maker, model and device ID to the actual notice. A company name alone is not enough. [7]
What is one dated example with a narrow scope?
Australia’s 2016 Physiomesh notice covered the version used through small cuts. It did not cover the Open version or all other mesh. [18]
Does a recall require mesh to be taken out?
Not always; FDA says some recalls involve checks or corrections. Discuss the personal risks and benefits with the surgeon. [9]
Does a report prove a recalled device caused harm?
A report alone rarely proves a device caused harm. FDA checks several kinds of safety data. [8]

The process

What happens next

  1. 01

    You answer a few questions

    About two minutes. Nothing is sent until you agree on the last step and press submit.

  2. 02

    A lawyer looks at it

    A lawyer at the firm reads your answers and checks them against the current case criteria.

  3. 03

    The firm decides and gets in touch

    If the firm takes your case, you get the terms in writing to read before you sign. You can always say no.

How should I check whether a notice applies?

Match the maker, model and device ID to the actual notice. A company name alone is not enough.

FDA recommends keeping the brand, material and identifier after surgery because they help check later safety information. Ask the doctor or hospital for the actual implant details and retain the notice with its date. Do not turn a list of brands into a finding that every model was recalled or caused harm.

What is one dated example with a narrow scope?

Australia’s 2016 Physiomesh notice covered the version used through small cuts. It did not cover the Open version or all other mesh.

The TGA described a recall of unused stock following higher recurrence or reoperation in two unpublished registries. The factors were not fully determined. That Australian action is not proof of a US FDA recall class or every patient’s cause. Check the original product and country scope before comparing it with your implant.

Does a recall require mesh to be taken out?

Not always; FDA says some recalls involve checks or corrections. Discuss the personal risks and benefits with the surgeon.

For an implant, a doctor should consider the risk of removal compared with leaving it in place. The TGA notice similarly left care decisions to the treating professional. A past recall is not an instruction to seek elective surgery, and a legal review should not replace a clinical recommendation.

Does a report prove a recalled device caused harm?

A report alone rarely proves a device caused harm. FDA checks several kinds of safety data.

Reports can be incomplete, delayed or unverified, so they are not a personal diagnosis or a patient risk rate. A randomized ventral trial separately compared two mesh materials and found fewer returning hernias with synthetic mesh at two years. It did not decide every recalled model’s risk or an individual legal claim.

How is recall history different from settlement history?

A safety notice and a court fund serve different purposes. Neither alone gives you a payment or confirms a claim.

Bard’s December 2024 fund order concerns agreed claims about Bard hernia products. It does not turn the separate Physiomesh notice into a Bard payment offer or publish amounts for every mesh patient. Ask a lawyer which product, harm, agreement and personal deadline fit the actual record.

What should I take to a device and claim check?

Keep the implant label, notices and care dates. Ask the clinician about care and the lawyer about legal terms.

Request covered hospital and billing records, noting access exceptions and copying charges. Include earlier cases, releases and any program correspondence rather than assuming an old notice is the newest record. Before legal work, read recovery shares and expense terms and confirm the next task. No payout estimate follows from a recall match.

Find out where you stand.

The review is free and private. Asking for it doesn’t commit you to anything.

Register your interest

Sources

  1. HHS: Your Medical RecordsHHS: Your Medical Records · regulator
  2. Federal courts: civil casesFederal courts: civil cases · court
  3. ABA: fees paid from a successful claimABA: fees paid from a successful claim
  4. SDNY: filing time limitsSDNY: filing time limits · court
  5. ABA Model Rule 1.5: feesABA Model Rule 1.5: fees
  6. FDA: surgical mesh used for hernia repairFDA: surgical mesh used for hernia repair · regulator
  7. FDA: questions and mesh identification after surgeryFDA: questions and mesh identification after surgery · regulator
  8. FDA: monitoring hernia mesh safetyFDA: monitoring hernia mesh safety · regulator
  9. FDA: what a device recall meansFDA: what a device recall means · regulator
  10. Bard/Davol CMO56 settlement fund, December16,2024Bard/Davol CMO56 settlement fund, December16,2024 · court
  11. Bard/Davol CMO54-A dismissal procedure, February19,2026Bard/Davol CMO54-A dismissal procedure, February19,2026 · court
  12. Bard/Davol CMO9-A court procedure, March3,2026Bard/Davol CMO9-A court procedure, March3,2026 · court
  13. Rosen original randomized hernia mesh trial, 2022Rosen original randomized hernia mesh trial, 2022 · study
  14. Becton Dickinson announced (Oct 2, 2024 press release) an agreement resolving the vast majority of Bard hernia mesh litigation — the federal MDL 2846 in S.D. Ohio and the Rhode Island consolidated docket, 21,000+ filed suits. Amount NOT publicly disclosed; BD said it sits within its existing product-litigation reserve and pays out over a multi-year structure, with individual plaintiff opt-ins required. (Media estimates of >$1B were not verifiable from a fetchable primary source, so no amount is reported.)aboutlawsuits.com · Oct 2, 2024
  15. Third MDL 2846 bellwether (Stinson v. Bard, PerFix Plug): jury found Bard liable on failure to warn, strict liability and negligence and awarded $500,000 in compensatory damages; no punitive damages. Stinson's mesh was implanted in 2015 and removed in 2017 after it 'curled up in a ball of scarred tissue.'aboutlawsuits.com · Nov 9, 2023
  16. Second MDL 2846 bellwether (Milanesi v. Bard, Ventralex): S.D. Ohio jury awarded $255,000 — $250,000 on negligent design defect plus $5,000 loss of consortium — while rejecting strict liability, failure-to-warn, misrepresentation and gross-misconduct claims. First plaintiff win in the MDL.aboutlawsuits.com · Apr 15, 2022
  17. First MDL 2846 bellwether (Johns v. Bard, Ventralight ST) ended in a complete defense verdict in the S.D. Ohio before Judge Sargus; the jury found for Bard on all counts, and Judge Sargus denied the plaintiff's new-trial motion on Dec 21, 2021. Fetched source confirms 'defense verdict in September 2021'; day-level date per trial coverage.aboutlawsuits.com · Sep 8, 2021
  18. Australian TGA Physiomesh hazard alert, June9,2016

Checked against 14 primary sources by People's Justice editors · Updated

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