Before a medical device can enter the U.S. market, it must receive approval from the U.S. Food and Drug Administration. What many consumers don’t realize, however, is the many different FDA approval levels that already exist. Johnson & Johnson’s subsidiary company, Ethicon, has a history with using the FDA’s 510(k) program to secure medical device approval. The FDA’s 510(k) approval process helps companies skip the rigorous pre-market and research studies required for clearing most medical devices. Ethicon sought 510(k) clearance for their Physiomesh hernia mesh repair product in 2010. Currently the fastest path to FDA approval (and market), 510(k) has a reputation for being easy, inexpensive, and less thorough. Since the FDA approved Ethicon Physiomesh without conducting clinical trials, thousands of hernia surgery patients suffered serious health complications.
How the FDA’s 510(k) Approval Process Works
All manufacturers must notify the FDA about their intent to market a medical device to consumers 90 days in advance. This helps the FDA determine whether that device is similar (or equivalent) to one that’s already approved on the market. “New” or breakthrough medical devices that don’t fit into this category must submit what is known as a PMA. Submitting a PMA (which stands for “Pre-Market Approval”) to the FDA is more time-consuming as well as much more expensive. For example, it cost roughly $31 million to bring a medical device to market under the 510(k) program in 2014. Compare that with the PMA’s average cost of about $94 million for FDA approval before entering the U.S. medical market.
Submitting a medical device for FDA 510(k) approval is substantially easier than using a PMA for several different reasons. In addition to being less expensive, it also allows for changes in the device’s manufacturing materials. Further, the device does not have to perform its intended purpose using the same technology as its “substantially equivalent” counterpart. Essentially, the device can differ greatly from a competitor’s proprietary model. Just as long as it falls within the same category and isn’t fundamentally different, the FDA can approve each medical device.
Lack of Clinical Trials May Have Contributed to Voluntary Ethicon Physiomesh Recall In 2016
In its May 2016 Ethicon Physiomesh Urgent Field Safety Notice, the company acknowledges its defects and referenced a recent study. This 2016 study showed Ethicon Physiomesh has a much higher failure rate than other widely available hernia mesh products. In fact, 20% of Ethicon Physiomesh implants fail within six months of implantation, requiring patients to undergo hernia revision surgery. Even more disturbing is that with each subsequent surgery, scar tissue build-up makes every revision attempt less likely to succeed.
Ethicon’s notice states, “Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors.” Since the FDA didn’t require clinical testing before launching Ethicon Physiomesh, the company didn’t anticipate so many adverse event reports. But several independent studies found Ethicon Physiomesh more likely to cause adhesions, seromas, hemorrhage and lower tissue integration in patients. Other experts suggest Ethicon Physiomesh is less flexible than other competing brands, making it more likely to tear or perforate.
No Ethicon Physiomesh clinical trials or premarket safety studies clearly contributed to the faulty product’s voluntary global recall in 2016. As a result, thousands of hernia repair patients received faulty mesh implants and now may require painful, expensive revision surgeries. Many injured patients are now filing Ethicon Physiomesh lawsuits.
What You Can Do
If you or a loved one had hernia repair surgery using Ethicon Physiomesh or any other type of surgical mesh patch, you may qualify for compensation. To get started, fill out your free hernia mesh claim evaluation today. After you submit your information, an attorney will contact you to discuss your options for getting the justice you deserve.
Mandy Voisin
Mandy Voisin is a freelance writer, blogger, and author of Girls of the Ocean and Star of Deliverance. As an accomplished content marketing consultant, mom of four and doctor's wife, Mandy has written hundreds of articles about dangerous drugs and medical devices, medical issues that impact disabled Americans, veterans' healthcare and workers' compensation issues since 2016.