Product News and Recalls

Ethicon Pulls Another Device Off the Market

problems with physiomesh lead to ethicon pulling device from officesEthicon’s decision to pull its Physiomesh surgical mesh off the market earlier this year is just one more in a string of failures for the medical device unit of Johnson & Johnson. The decision comes from mounting evidence of a higher number of revision surgeries associated with Physiomesh than with other similar surgical mesh devices.

Data compiled from two separate hernia registries showed problems for Physiomesh when it is used in laparoscopic ventral hernia repair procedures.

Publically, the company isn’t exactly sure what is causing the problems that lead to the revision surgeries. In a statement, Ethicon said that the failure could be “multifactorial” in nature, citing possible issues with “product characteristics, operative, and patient factors.” Translated, this means that the company hasn’t been able to figure out (or admit) if the Physiomesh issue is a design flaw, operator error, or an issue with the patients in which the device has been implanted.

The halt in production is directed more to health care facilities than to actual patients. Those already implanted with the device are advised to simply continue with their current follow-up care routine. Doctors, according to Ethicon, should continue to follow the patients as usual. Facilities, on the other hand, have been advised to return their existing stocks of Physiomesh devices and not use them. At the same time, Ethicon has discontinued sales of the mesh device until the cause for the higher number of revisions can be determined.

This is far from Ethicon’s first issue with one of its devices. A firestorm continues to rage over the company’s power morcellator units and their alleged link to spreading as-yet undiagnosed uterine cancer throughout a woman’s abdomen during surgery. At the same time, the company has come under fire for its transvaginal mesh devices. Tens of thousands of transvaginal mesh lawsuits have been filed; so many in fact that the company accused plaintiffs’ lawyers of using unethical methods to recruit new clients into the case. That accusation was later dropped.

At least one lawsuit has already been filed over the Physiomesh device amid allegations that the implant became so embedded in the patient’s body that parts of it had to be left in place when doctors tried to remove it. The patient, a Florida woman, underwent a two-hour procedure to remove the mesh before surgeons determined that not all of it would be able to come out.

Whether this is the first lawsuit in a coming flood, as has been the case with other Ethicon devices, remains to be seen.