Hernia mesh manufacturers and the FDA have issued hernia mesh recalls concerning certain types of hernia mesh. A hernia mesh recall is a serious matter and is certainly strong evidence that the hernia mesh medical device is defective. Victims have filed thousands of hernia mesh lawsuits even though the particular type of mesh was never recalled by the FDA. A hernia mesh recall is not required to file a hernia mesh lawsuit! Many people incorrectly believe they cannot file a lawsuit because their hernia mesh is not under recall and was never recalled. The vast majority of hernia mesh was never recalled. Many people mistakenly believe that the voluntary removal of Ethicon Physiomesh from the market constituted a hernia mesh recall. However, there was never a Physiomesh recall. Ethicon’s removal of Physiomesh from the market was for all intensive purposes a defacto hernia mesh recall. Physiomesh was actually recalled in Canada.
Update- 8/06/2023– There have been no hernia mesh recalls in 2023.
A Recall is not a prerequisite to filing a hernia mesh lawsuit
Most victims are surprised to learn that it is not required that there be a hernia mesh recall in order to file a hernia mesh lawsuit. A hernia mesh recall is not a prerequisite to receiving compensation and justice as a result of defective hernia mesh. Hernia mesh can still be defective even if there was no FDA recall or no market withdrawal of the mesh.
Prominent Hernia mesh recalls
Below you will find some prominent hernia mesh recalls issued by the FDA. The most significant recalls appear to be the 2005 Bard Kugel mesh recalls.
2018 mesh recalls
- Versatex Monofilament- Mesh 50 x 50 cm. Class 2 Device Recall- Read the FDA recall “There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device’s Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.” Id.
- ProLite Mesh, Class 2 Device Recall ProLite Mesh “An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298.”
2016 hernia mesh recall (removal)
- ETHICON PHYSIOMESH™- URGENT: MEDICAL DEVICE REMOVAL – Flexible Composite Mesh (All Product Codes) (Editors note: this was not actually a hernia mesh recall but for all intensive purposes is a hernia mesh recall. This was a voluntary market removal by the manufacturer Ethicon. Ethicon is part of Johnson and Johnson)
2013 Atrium hernia mesh recall
- Atrium CQUR Edge Mesh– FDA Class 2 Device Recall- “Atrium Medical issued Recall Letter via UPS and e-mail on 7/19/13 to the accounts and field representatives. The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve. A reply for is requested to be completed to acknowledge receipt to the notification. Additional language to the instructions for use (IFU) to include: Prolonged exposure to high humidity may result in increased rate of adherence of the C-QUR mesh to its handling sleeve. Store in a Controlled Room Temperature (25 C / 77 F ) or less. Brief exposure to up to 40 C (104 F ) is acceptable. Questions please contact Atrium Medical Customer Service at 1- 800- 528-7486 Monday through Friday 9:00 am to 5:00 pm EDT.’
2010 Proceed hernia mesh recall
2006 Bard Kugel hernia mesh recall
- Bard Composix Kugel Mesh “The recalling manufacturer, Davol, said “memory recoil ring” can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).” Access the link at www.fda.gov/cdrh/recalls/recall-122205.html (http://www.fda.gov/cdrh/recalls/recall-122205.html) for the codes.
- In 2006, Bard recalled Kugel Mesh. The expanded class 1 FDA recall on Febuary 22nd 2006 included “certain lots of the Large Oval and Large Circle products, as well as all lots of the Oval product” Id. The recalling firm was: “Davol, Inc., Sub. C. R. Bard, Inc.”
|Z-0524-06 – Bard Composix Kugel Mesh X-Large Patch Oval With EPTFE, 8.7” X 10.7” Code: 0010206||1||02/22/2006||Davol, Inc., Sub. C. R. Bard, Inc.|
|Z-0525-06 – Bard Composix Kugel Mesh X-Large Patch Oval With EPTFE, 10.8” X 13.7” (25.4cm X 33cm) Code: 0010207||1||02/22/2006||Davol, Inc., Sub. C. R. Bard, Inc.|
|Z-0762-06 – Bard® Composix® Kugel Oval, 6.3” X 12.3” For Hernia Repairs Product Code: 0010209||1||02/22/2006||Davol, Inc., Sub. C. R. Bard, Inc.|
|Z-0760-06 – Bard® Composix® Kugel Large Oval, 5.4” X 7” For Hernia Repairs Product Code: 0010202||1||02/22/2006||Davol, Inc., Sub. C. R. Bard, Inc.|
|Z-0761-06 – Bard® Composix® Kugel Large Circle, 4.5” For Hernia Repairs Product Code: 0010204||1||02/22/2006||Davol, Inc., Sub. C. R. Bard, Inc.|
|Z-0526-06 – Bard Composix Kugel Mesh X-Large Patch Oval With EPTFE, 7.7” X 9.7” (19.6cm X 24.6cm) Code: 0010208||1||02/22/2006||Davol, Inc., Sub. C. R. Bard, Inc.|
2007 Bard hernia mesh recall
- Bard Kugel Hernia mesh– Davol extends the Kugel recall to include Large Sized Composix Kugel Patches (oval and circle) due to additional reports of memory recoil ring breakage. Another product with the same component design is also recalled because of the potential for breakage.” Settlements January 10, 2007 the following medical devices were recalled:
- Bard Composix Kugel Hernia Patch Large Oval with EPTFE, 5.4” x 7”
- Bard Composix Kugel Hernia Patch Large Circle with EPTFE, 4.5”
(recalled as a result of ring breakage causing Bowel Perforation and “chronic enteric fistula.” https://www.drugwatch.com/hernia-mesh/)
Many victims are asking the following questions:
- How do I know whether my hernia mesh is recalled?
- How do I know if I have a hernia mesh lawsuit?
- Signs of infected hernia mesh?
- What are the Hernia mesh symptoms?
Free hernia mesh case evaluations
We review cases nationwide for hernia mesh victims who have endured pain and suffering as well as complications as a result of defective or recall hernia mesh medical devices.
Victims not informed of mesh implanted
Many victims are totally unaware, whether the mesh implanted into their body is a recalled medical device or has been removed by the mesh manufacturer from the market. We can help determine if a mesh victim has a case.
Evading surgical mesh recall using market withdrawal tactic
It is all too common that hernia mesh recalls are not known to the victims / consumers. Hernia mesh surgeons are made aware of the surgical mesh recalls but the victims are often left in the dark. Some manufacturers evade a hernia mesh recall by surreptitiously removing the hernia mesh medical device from the market rather then recalling the surgical mesh. Some victims are not notified of the mesh recall until they develop severe complications and side effects from the defective hernia mesh.
Even if you do not know the type of mesh implanted you can get legal help
Even if you do not know what type of mesh was implanted, you can still contact us to determine whether you are eligible for compensation as a result of the defective mesh. Many victims can start the process of receiving justice and compensation even though they do not know what mesh was implanted in them. A good hernia mesh law firm will help the mesh victim obtain his or her medical records and surgical records .Some victims of Bard / Davol mesh may even get an extended statute of limitations which may be nearly endless. Contact us to determine whether you qualify for a nearly endless hernia mesh statute of limitations.
Hernia mesh complications
“Based on FDA’s analysis of medical device adverse event reports and of peer-reviewed, scientific literature, the most common adverse events for all surgical repair of hernias—with or without mesh—are pain, infection, hernia recurrence, scar-like tissue that sticks tissues together (adhesion), blockage of the large or small intestine (obstruction), bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the surgical site (seroma), and a hole in neighboring tissues or organs (perforation). Source
“The most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).” Id.