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. Many people mistakenly believe that the removal of Ethicon Physiomesh from the market constituted a hernia mesh recall. However, there was never a Physiomesh recall.

Many victims are asking the following questions:

 

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.

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.

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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.

Recall is not a prerequisite to receiving compensation

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.

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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.

Below you will find some prominent hernia mesh recalls in the past:

2018 mesh recall

Class 2 Device Recall Versatex Monofilament Mesh 50 x 50 cm

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162927

“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.”

Class 2 Device Recall ProLite Mesh

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161830

“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

URGENT: MEDICAL DEVICE REMOVAL ETHICON PHYSIOMESH™ Flexible Composite Mesh (All Product Codes) (Editors note: this is not actually a hernia mesh recall)

2013 hernia mesh recall

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=119924

Atrium Medical Corporation
5 Wentworth Dr
Hudson NH 03051-4929

Class 2 Device Recall CQUR Edge Mesh

“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 hernia mesh recall

Class 2 Device Recall PROCEED Surgical Mesh

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95190

2005 hernia mesh recall

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.