A hernia mesh recall helps build the case against defective device manufacturers, but it’s not necessary to file a lawsuit for your injuries. Despite the myriad of hernia mesh complaints over the past decade, the U.S. Food & Drug Administration (FDA) has done surprisingly little to stem the tide.
The FDA is under scrutiny for the 510(k) clearance process that allowed harmful hernia mesh products to rush to market after an accelerated review. In November 2018, FDA Commissioner Scott Gottlieb announced the administration planned to overhaul the process in response to media investigations into patient injuries.
There are three MDLs concerning hernia mesh ongoing right now. These products all have a history of some type of recall. In most cases, manufacturers quietly halted production temporarily or voluntarily issued new warnings to surgeons when they learned of serious risks and failures.
Recalls prevent new patients from developing complications, but they do nothing for patients at risk who have already received the implants. If your hernia mesh has been recalled, a “wait-and-see” approach is recommended, rather than seeking immediate surgery to have it proactively removed. If you are one of the patients suffering adverse effects of hernia mesh, contact Showard Law Firm for a free consultation. We are taking cases nationwide.
Ethicon Physiomesh Recall
Ethicon first released their Physiomesh for hernias in October 2010. In a May 25, 2016 letter to healthcare providers, Ethicon announced that they were voluntarily pulling their Physiomesh Flexible Composite Mesh line from the global market after a review of unpublished data by European registries revealed a much higher rate of failure with Physiomesh compared to other products on the market.
Product codes for the recalled items include:
- PHY0715R
- PHY1015V
- PHY1515Q
- PHY1520R
- PHY1520V
- PHY2025V
- PHY2030R
- PHY2535V
- PHY3035R
- PHY3050R
- ELH5
- ELH10
The company believes the higher revision rates are “multi-factoral” – including “product characteristics, operative, and patient factors” they have been unable to identify.
The recall does not involve any other Ethicon meshes, including the Physiomesh Open Flexible Composite Mesh or any other products.
As of November 2018, MDL 2782 contained 1,513 pending lawsuits, alleging harm caused by the Ethicon Physiomesh Flexible Composite Hernia Mesh. New lawsuits are joining the litigation each month. The first bellwether trial is scheduled for December 2, 2019.
Atrium C-Qur Mesh Recall
Atrium Medical Corp began distributing the C-Qur Mesh medical device in 2006. An FDA Class II Recall for 95,286 units was initiated on July 19, 2013. Class II recalls represent an intermediate threat level where there is “no immediate danger” of death or serious injury, but a remote risk is still present.
The manufacturer cited “package design/selection” as the reason for the recall. According to the recall notice, “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.” No products were pulled from the market at the time; rather, medical professionals were notified of the humidity risks. The recall status was terminated on March 18, 2016.
However, the recall was not the only trouble Atrium faced. The U.S. Department of Justice filed a February 3, 2015 complaint in the U.S. District Court for the District of New Hampshire at the request of the FDA, alleging the company sold adulterated and misbranded medical devices, including surgical meshes. According to the complaint, the Hudson, New Hampshire manufacturing facility deviated from good manufacturing practice requirements and device makers failed to implement corrective and preventive actions mandated by the FDA following 10 inspections between 2009 and 2013.
As a result, a consent decree of permanent injunction was filed, requiring Atrium to shut down their facility until the corrective actions were completed and pay the US government a $6 million fine. Although the Hudson facility was shut down, the product is still available and being implanted at some hospitals.
MDL 2753 contains 867 lawsuits pending. Atrium has set aside at least $200 million to deal with the ongoing litigation, with the first bellwether trial expected by February 20, 2020.
Bard Hernia Mesh Recall
Visilex Mesh was C.R. Bard’s first approved hernia mesh, dating back to 1995. The infamous Composix Kugel patches were released one year later. More than 100,000 units of Kugel mesh were Class 1 recalled in 2006 after 34 memory coil rings broke, causing serious injuries and at least one death. In 2011, the company settled 3,000 Kugel mesh lawsuits for $184 million.
A Class 3 Device Recall was initiated by the firm on December 8, 2008 once they realized the “right-side” and “left-side” models of Lot Code 43JQD016 of Bard 3D Max Mesh were mislabeled. Class 3 recalls are “not likely to cause adverse health consequences.” The recall was terminated on May 2, 2012.
As of November 2018, there were 209 lawsuits in MDL 2846 for Davol Inc. / C.R. Bard Inc. Polypropylene Hernia Mesh.
What to Do If Your Hernia Mesh Is Causing Problems
If you have suffered complications after hernia surgery, you likely have many questions. Some patients call their surgeon’s office to learn which type of mesh was implanted if they are unsure. Here at the Showard Law Firm, we can also investigate the type of mesh you had implanted, as well as any known issues or recalls associated with the product. The hernia mesh litigation is still growing and it’s not too late to seek compensation for your injuries. Contact our law office for a free consultation to learn more.
Additional Hernia Mesh Recall Resources:
- CNBC – FDA to Overhaul 510(k) Medical Device Approval Process, https://www.cnbc.com/2018/11/26/fda-to-overhaul-510k-medical-device-approval-process.html
- Federal Institute for Drugs and Medical Devices – Ethicon Physiomesh Recall, https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2016/04429-16_kundeninfo_en.pdf?__blob=publicationFile&v=2
- US Department of Justice – District Court Enters Permanent Injunction Against NH Company, https://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-new-hampshire-company-and-senior
- FDA – Class III Recall, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75464
- FDA – List of Recalled Devices – Bard Composix Mesh, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=34393
JPML – Pending MDL Dockets [November 2018], https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-November-15-2018.pdf