Lawsuit for Ethicon Physiomesh
In the Federal court system of the United States, there are three separate Physiomesh cases. Ethicon continues to deny the Physiomesh was recalled by them. Ethicon keeps the position that they, in May of 2016, just withdrew voluntarily Physiomesh from the market. After independent studies revealed high rates of complications for patients surrounding the use of Physiomesh, Ethicon “voluntarily removed” the Physiomesh. Before this voluntary removal, surgeons and patients alike had spoken poorly Physiomesh to no avail. The criticisms were not enough to influence Ethicon that they might have a bad product. This is because Ethicon did not want to lose the stream of income Physiomesh had created. Physiomesh Open was created before Ethicon decided that Physiomesh would be removed from the market. A 510(k) application was filed for the Physiomesh Open in June of 2014 and was approved in late October of the same year. In using this strategy, Physiomesh Open was kept on the market for six months to before the regular Physiomesh was voluntarily withdrawn.
Lawsuits were filed against Ethicon, a small branch of the larger, Johnson & Johnson, the company responsible for Physiomesh. Physiomesh was originally meant to be used for hernia repair surgeries. The material used to make it is polypropylene, the same material used in the company’s transvaginal meshes, which have also been a source of lawsuits for Ethicon. The danger of polypropylene and the risks associated with it are something Ethicon has repetitively denied. Although, they did decide to do a complete removal of the product from the market in May of 2016.
Ethicon Physiomesh and Approval by the Food and Drug Administration
On April of 2010, Physiomesh was first approved by the Food and Drug Administration (FDA). The approach Ethicon took for the approval process was the 501(k) program. This permitted Ethicon to avoid some of the stringent studies normally applied to product before being put on the market. The claim made by Ethicon was that this product, Physiomesh, was basically the same as another hernia patch produced by Ethicon called Proceed. In June of 2014, a version of Physiomesh that had been modified was entered in the 510(k) process for FDA approval. The revised Physiomesh product was approved in October of 2014. It was noted by the FDA, however, that this 510(k) approval process for Physiomesh did not mean that the product had conformed to Federal regulations and statutes, as well as any other regulatory agencies.
The Components of Physiomesh
The base layer of Physiomesh is polypropylene, which is the same product used in both the bladder slings and transvaginal mesh also manufactured by Ethicon. Thousands of lawsuits erupted from the two previous products containing polypropylene. A coating of film was put on both side a piece of polypropylene to produce Physiomesh as a final product. The film coatings were created from different components and were added to try preventing the human tissue from destroying the polypropylene, which is what occurs when the two come in contact directly.
Withdrawal of Physiomesh from the Market
In May of 2016, a field safety notice was given urgently by Ethicon, in which, instructions were given for use of Physiomesh in hernia repair surgeries to be discontinued. Continual denial was given by both Johnson & Johnson and the subsidiary, Ethicon, concerning Physiomesh being pulled from the market. It was, at this point, still not listed on the FDA’s website as a recalled product. Currently, examinations are being conducted on Physiomesh and the ratio of recurring hernias or any other additional surgeries. More than likely, a significant amount of complications have been discovered explaining why Ethicon decided to pull Physiomesh from the market.
It was possibly the components of Physiomesh were responsible for the removal of the product due to the associated complications. However, Ethicon stated that the removal the complications were related to components of the Physiomesh product in the withdrawal notice given before the final pulling of the product, yet the company said that they had not yet identified anything problematic with the Physiomesh. They also admitted that complications with Physiomesh seen by doctors could not be prevented through Ethicon nor could they provide any information to stop recurring hernias. A separate company, Atrium Medical Corporation and mother company, the Getinge Group, sought to gain sales by contacting physicians and encouraging the use of their own product, the C-Qur Hernia Mesh. However, the FDA, as well as consumers, had brought about multiple lawsuits against Atrium concerning their product.
The Defective Design of Physiomesh
It was made aware to Ethicon that Physiomesh was problematic and potentially dangerous for patients since the beginning of its use. All any other coated meshes for hernia repairs, Physiomesh is coated thickly on both sides, which is meant to protect the human bowels from exposure to the polypropylene. The reason for this is because polypropylene will adhere to human tissue and when this occurs, injury will follow. Although, if there is no part of the polypropylene left exposed, the mesh and the abdominal wall will not attach correctly. If this attachment does not take place, the mesh will be unstable and move loosely throughout the abdominal cavity of the individual with the mesh implant.
There was also polypropylene of a lighter weight that was used in Physiomesh than in the prior hernia mesh implants Ethicon produced. Less polypropylene was used so as to attempt limiting the complications being seen by doctors and patients; however, Physiomesh was far weaker due to the lesser amounts of polypropylene than that other the previous models. The problem with this is that a tear or rip would occur in the Physiomesh after implantation in the patient.
Complications from Physiomesh
The Physiomesh is still linked to a multitude of bowel obstructions, seromas, disorders, and high rates of failures concerning the mesh.
The rate of additional surgeries is significantly high due to this poor construction and weakness in design. A following surgery is normally required with the implant to fix the tearing and moving around of the Physiomesh product. In addition, the rate of a hernia recurring in the patient is far higher.
Device Tags for Physiomesh
You will need to get your private medical records from the hospital where your implantation surgery was done and the device tags for the Physiomesh product. They are available on request from the hospital. Require that you need to receive device tags, surgical reports, and equipment labels. The hernia web equipment labels must confirm which hernia internet was utilized during your operation. It is not uncommon for the report which is surgical use a general name for the hernia web. A more generic moniker may be designated for the hernia mesh in the operative report. Hernia meshes are being produced by new companies so quickly that it is easy to see that tons of surgeon might not be certain as to which one is recalled and which they are installing. Johnson and Johnson ’s subsidiary company Ethicon removed all TON numbers of the Physiomesh from the business.
Device tags may also be called the “Product Traceability Label.” The device tags states that Ethicon produces Physiomesh. The PHY1520V is the catalog number, which is often utilized to order a specific Physiomesh. The date will be indicated as October 2014 for expiration. The LOT number indicates a batch of Physiomesh that were made in a special location at a specific time. LOT numbers are useful in discovering if the defect was in one product or the entirety of the batch. The LOT number for Physiomesh is EM8DDQA0.