August 10, 2019 | Mass Torts
Hernia mesh – the surgical device used to treat inguinal, femoral, incisional, ventral, umbilical, and hiatal hernias – is involved in nearly 90% of hernia repair operations. Problematically, surgical hernia mesh has earned a reputation for its often-serious defects, resulting in significant post-operation injuries and widespread recalls by both the U.S. Food and Drug Administration (FDA) and device manufacturers.
As a result of the documented issues and adverse reactions associated with hernia mesh, the FDA has issued recalls for many types of hernia mesh. In addition to the severe injuries and significant adverse physical reactions associated with hernia mesh, the FDA has also issued hernia mesh implant recalls for comparably benign reasons, such as mislabeling of packaging, and the use of cheap/counterfeit materials. In addition to FDA ordered recalls, many hernia mesh manufacturers have voluntarily recalled their hernia mesh products after receiving reports of injuries suffered by patients.
In total, since 2005, over 211,000 units of hernia mesh implants have been recalled.
| Manufacturer: | Atrium Medical | Reason for Recall |
|---|---|---|
| Date: Aug 9, 2013 | C-QUR Edge Mesh | Improper Packaging |
| Units: 145, 251 | C-QUR TacShield | Improper Packaging |
| C-QUR V-Patch Mesh | Improper Packaging | |
| C-QUR Mesh (All Sizes) | Improper Packaging | |
| — | — | — |
| Manufacturer: | Bard Davol | Reason for Recall |
| Date: Dec 2005 – Jan 2007 | Bard Composix Kugel Mesh X-Large Patch Oval | Potential of Ring Breaking, Causing Bowel Perforation, or Fistula |
| Units: 48,364(+) | Bard Composix Kugel Large Oval (5.4” x 7”) | Potential of Ring Breaking,Causing Bowel Perforation, or Fistula |
| Bard Composix Kugel Oval (6.3” x 12.3”) | Potential of Ring Breaking, Causing Bowel Perforation, or Fistula | |
| Bard Composix Kugel Large Circle (4.5”) | Potential of Ring Breaking, Causing Bowel Perforation, or Fistula | |
| Bard Composix Kugel Hernia Patch Large Oval with EPTFE (5.4” x 7”) | Potential of Ring Breaking, Causing Bowel Perforation, or Fistula | |
| Bard Composix Kugel Hernia Patch Large Circle with EPTFE (4.5”) | Potential of Ring Breaking, Causing Bowel Perforation, or Fistula | |
| Bard Ventrio Hernia Patch Small Oval(8cm x 12cm) | Labeling Mix-Ups | |
| Bard Mesh Pre-Shaped | Process Control | |
| Bard Ventralex Hernia Patch Medium Circle | Labeling Mix-Ups | |
| Bard 3D Max Mesh, Pre-Formed | Mix-Up of Materials and Components | |
| Bard Ventralight ST Mesh (Various Sizes) | Packaging Process Control | |
| — | — | — |
| Manufacturer: | Ethicon | Reason for Recall |
| Date: Dec 2005 – May 2016 | Proceed Surgical Mesh | Potential to Lose Laminate Coating (Exposing Mesh to Bowels and Causing Adhesions or Bowel Fistulation) and Packaging Defect |
| Units: 18,310 (Proceed), All Units (Physiomesh) | Physiomesh Flexible Composite Mesh | High Failure Rates Reported |
It is important to note that in the event of injury from a recalled hernia mesh, the hernia manufacturer is financially and legally liable. As such, if you sustained an injury from a recalled hernia mesh, you may be eligible to file a lawsuit for negligence, defective design, or failure to warn (regarding defects or health risks). A successful lawsuit will demonstrate that your hernia mesh implant had a manufacturing and design defect, resulting in a serious injury. Moreover, a qualified attorney will recover damages, in the form of a financial award for compensatory and (potentially) punitive damages, covering your costs for medical bills, pain and suffering, lost wages and lost future wages.
If you have suffered complications with any of the recalled hernia mesh implants listed above, we recommend contacting your physician to determine the severity of your injury and an attorney to discuss your legal options. The highly qualified and impassioned team of attorneys at the Dunken Law Firm has extensive experience litigating hernia mesh related cases. Contact us at (713) 554-6780 for your free consultation and case evaluation, today.