In May 2016, Ethicon, a subsidiary of Johnson & Johnson, announced it was pulling Physiomesh off the market in light of higher than average injury rates in patients using Physiomesh compared to other types of meshes. This market withdrawal, as well as the number of victims who suffered adverse reactions before it was implemented, raises the question of why the Food and Drug Administration (FDA) issued approval for the product in the first place. If you want to know more about Physiomesh and the FDA, consult a knowledgeable attorney that could answer your questions.
When a company submits an approval application to the FDA for a medical device that is different from any other already approved device, they must go through the agency’s premarket approval process. The company is required to show how the device will help a significant portion of the targeted patient market.
They must also submit both clinical and non-clinical studies proving that the possible benefits the device offers far exceed the possible side effects and risks it may cause. Clinical research involves studying the effectiveness and safety of the device when implemented in patients. Researchers collect and report all data regarding complications, adverse reactions, and device failures.
Non-clinical studies do not involve human testing but may include animal testing. In these types of studies, researchers test for issues such as biocompatibility, toxicology, microbiology, how the device holds up to wear, and how long the device will last.
Approval via 510(k) Program
The FDA, however, offers manufacturers another type of approval process, called the 510(k) program. This program allows companies to apply for approval without conducting any testing on people if they can show that the device is very similar to another already approved device.
The FDA granted approval to Ethicon for Physiomesh in 2010 through its 510(k) program. Ethicon had tested Physiomesh on animals but had not conducted any human clinical trials. In its approval application, Ethicon claimed to the FDA that Physiomesh was substantially similar and just as effective as three other brands of Ethicon mesh that the FDA has previously approved: Proceed Mesh, Ultrapro Hernia System, and Ultrapro Mesh.
Multiple Adverse Reactions Complaints
One of the biggest issues with the 510(k) approval process is that it relies solely on the manufacturer’s assurances that their product is both effective and safe, without requiring clinical trials to back up those assurances.
In the case of Ethicon, the company has had serious issues with other mesh products they have developed and gained approval to market, including their transvaginal mesh and their bladder slings. Despite thorough documentation in study after study that polypropylene mesh can cause major medical injuries and death in patients, the company continued to develop products using the material, including Physiomesh.
Because of the inherent dangers and controversy surrounding Physiomesh, the company had to pull the product off the market. It is recommended that patients who still have Physiomesh consult with their physician about removal or other medical options available to them, as it can sometimes take years for the medical issues from the mesh to develop and symptoms are not always obvious. If an individual wants to know more about Physiomesh and the FDA approval process, they should consult an attorney that could answer those questions.