« All FAQ About Hernia Mesh

What Is The Problem With Physiomesh, C-QUR, and other Polypropeline Meshes?

Manufactured by Ethicon, the Physiomesh product was cleared through the FDA 510(K) approval process in 2010. The FDA 510(K) approval process is used when a product is modeled after a device that has been fully approved by the FDA, and it requires less testing than the FDA requires for new medical devices on the market. Using the FDA 510(K), Ethicon conducted minimal testing on mesh devices. In tests that were conducted, most patients experienced some type of issue with the product. Furthermore, Ethicon may have concealed unfavorable results and failed to conduct any clinical trials on the product, ensuring the product entered the market as quickly as possible. In May 2016, Ethicon voluntarily withdrew the device from the market.

Similarly, the C-QUR product (manufactured by Atrium) has a history of defective design and deceptive marketing tactics. In fact, the FDA issued several warnings to Atrium, yet the company failed to improve the design and cease its deceptive marketing promises. Evidence also suggests that general surgeons who conduct mesh surgeries were promised impossible results and given false or misleading information about the device. At least one clinical trial is known to have been terminated due to concerns with the product.

Related Questions:

What is a Hernia?

A hernia occurs when an organ bulges through weakened tissue or abdominal opening, and it can be caused by a number of different things. These ruptures often develop after surgery, where the tissue is in a weakened state and susceptible to damage. Hernias may occur in the abdomen, upper thigh, groin, and/or belly button, and… read more?

How is a Hernia Mesh Used?

Surgical mesh is a medical device attached to the weakened tissue, or hernia, to provide support and prevent the organ from continuing to push through the wall. Three different types of mesh may be used for hernia repair: Synthetic, which is generally made of polyester and polypropylene.Biologic, which is made of biological material such as… read more?

What Other Mesh Products Are Being Investigated?

In addition to Ethicon Physiomesh and Atrium C-QUR, we are also investigating the following mesh products: Bard, including but not limited to:Kugel3D MaxVisilexSpermatexVentralight STSeprameshSepramesh IPPerFix PlugMarlexCompositeMarlexGeneric Bard meshComposix (including E/X)Covidien, including but not limited to:ParieteneParietexSurgiproPermacolSurgiproGoreDualmeshDualmesh PlusEthicon, including but not limited to:Prolene Hernia SystemPhysiomeshProlene 3D PlugProceed Surgical PatchProceed Ventral PatchAtrumC-QUR read more?