Physiomesh went through bench trials and animal testing before being approved by the Food and Drug Administration. It was not tested on humans before going into circulation. Bench trials are like virtual trials in which they virtually try to replicate what would happen if this mesh was implanted into a human body. Animal testing allows one to see what would actually happen if they put the mesh into animals.
Ethicon claims that Physiomesh underwent a comprehensive bench and animal testing program and passed all intended criteria. However, Physiomesh has been prone to cause complications. If you have been one of the many who have suffered due to the Physiomesh, seek the services of a capable Physiomesh lawyer who is knowledgeable about the Physiomesh and the Food and Drug Administration in West Palm Beach.
FDA Responsibility to Side Effects or Product Failures
For those who have suffered from Physiomesh side effects or failure, the FDA is responsible for notifying the public about what is going on with the medical devices. If there is a problem, the FDA tries to publish it and get it to the public as soon as possible. However, they have immunity, so they try to warn the public and give ways for the companies to do so, but they can only do the best that they can. Anyone can go on to the FDA’s website and look up any safety notices.
Why the FDA Believed the Physiomesh was Reasonably Safe
The FDA assumed that Physiomesh would be reasonably safe because it was substantially equivalent to meshes that have already been on the market. Ethicon, the manufacturer of the Physiomesh, requested the approval through the 510(k) process, which is more of a limited process. When the FDA receives the request, they have a limited amount of time, usually, 90 days before the company wants to put the product on the market. Parts of the Physiomesh were created very similar to these other meshes that were already on the market. It met the standards that the FDA requires and that is why the FDA thought Physiomesh would be reasonably safe.
What is the 510(k) Exemption?
The 510(k) exemption means that a product made was found to be substantially equivalent to a product is currently on the market and was already approved by the FDA. The exemption allows products to go on the market without any clinical trials and very little evidentiary support.
The 510(k) allows companies to get medical devices on the market without human testing. This is why companies will try to get on the market faster by making products only slightly different than products that have already been approved by the FDA. All the company has to do is submit its application to get this product approved by the FDA 90 days prior to releasing it. However, if there are any problems with what the FDA sees in the application, they can deny it or ask questions of why this product is substantially equivalent to other products that have already been passed.
Devices that are not considered dangerous are eligible for the 510(k) exemption. The FDA allows these products to go through lighter testing. For more information about the 510(k) exemption and how it applies to the Physiomesh and the Food and Drug Administration in West Palm Beach, contact a well-established lawyer.
Other Hernia Mesh Products on the Market
There are many hernia mesh products that were on the market before Physiomesh. The most similar product was called the Proceed Mesh. There are also many different versions of Proceed Mesh that are on the market as well. Also, there is the UltraPro Hernia System and the UltraProMesh that were submitted through the 510(k) process. It is possible for a company to get devices that are slightly different from each other approved by the FDA.
Difference Between a Cleared and Approved Medical Device
The difference between a cleared medical device and an approved medical device is the process. Through the 510(k) process, the medical device will end up being cleared and released. It is allowed so that people can perform surgeries and put these medical devices in people, which is a lower standard.
Any devices that are approved by the FDA go through a different route, which is the pre-market approval. That requires more expensive testing, sometimes human testing. The FDA is saying this product is safe to their standards and that is why they approve it but other ones are just cleared. If you have any questions regarding the Physiomesh and the Food and Drug Administration in West Palm Beach, contact an attorney today.