A common question is “Has my hernia mesh been recalled?”
This presumes that our consumer watchdog agency, the U.S. Food and Drug Administration (FDA), recalls from the market medical devices that are causing U.S. consumers problems.
That is not really the way it happens.
The FDA bends over backward NOT to recall devices and instead defers to the manufacturers to voluntarily remove from the market a troubling device that is harming consumers.
Instead, voluntary removal or withdrawal from the market allows a manufacturer to allegedly “fix” the problem and put the device back on the market. According to FDA guidance documents issued in October 2014:
“Market withdrawal means a firm’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which involves no violation, e.g. normal stock rotation practices, routine equipment adjustments and repairs, etc. a market withdrawal is not a recall.”
The voluntarily withdrawn device can be reintroduced onto the market with some design tweaks. Just because it is not a recall should not indicate a withdrawal is any assurance of safety. Consider:
*Recall – 2005 Bard Davol Composix Kugel mesh product. 47,000 units. Completed. Settled for $184 million in 2011.
*Recall – 2010 Ethicon Proceed surgical mesh (one lot and delamination problem), 18,000 units. Open
*In June 2010, the FDA announced a Class 1 Recall and Safety Investigation of Counterfeit Polypropylene Surgical mesh. A laboratory analysis in 2010 revealed that the mesh was not sterile, which could increase the risk for infection. Various lots were recalled.
*Recall -2013 Atrium C-Qur Edge Mesh (sticking to packaging in certain high humidity conditions). Terminated March 2016. 145,000 units.
*Removal – 2016 Ethicon’s Physiomesh Flexible Composite Mesh- Open
*Recall – 2018 Atrium Medical’s ProLite Mesh patches (mislabeled packaging) – Closed
*Recall – 2018 some Versatex Monofilament Mesh by Sofradim – Still Open
Despite a recall, Atrium’s C-Qur is still on the market.
The government will tell you it avoids costly litigation to work closely and in cooperation with industry to initiate a withdrawal.
But a voluntary recall means the decision making is in the hands of the very company that made the problematic product in the first place. And it may mean you cannot depend on that recall/withdrawal as a guidance to whether or not your mesh causes complications.
Jane Akre is an American journalist based in Florida. In 1997, she was fired from a Fox News while working at a Fox affiliate in Tampa for refusing to include knowingly false information in a report on the safety of a product produced by the Monsanto Corporation. Currently, she is the National News Editor for the Mesh News Desk (MND)—an online news source that covers the complications associated with surgical meshes. Through such reporting, MND looks to put a face on adverse events that affect everyday people.