Product News and Recalls

Medical device regulations criticized

A story in Canadian news magazine MacLean’s deals with the haphazard nature of medical device regulation, characterizing the problem as a “scandal in the making.”

According to the article, flawed oversight of medical devices – essentially any medical product that doesn’t work through a chemical process – is an international problem that exists in the United States and Europe, as well as Canada.

The article specifically mentions two medical devices that serve as cautionary examples of what can happen as a result of inadequate regulation: the all-metal hip implant and the transvaginal mesh implant.

In the United States, a jury recently awarded $11.1 million to a woman injured by a vaginal mesh implant that Johnson & Johnson’s Ethicon division manufactured. That case represented the first of more than 11,000 lawsuits regarding the devices to go to trial, filed by women complaining of health problems that include infection, organ perforation and chronic pain.

In a separate case, another U.S. jury awarded $8.3 million to a man injured by an all-metal ASR hip implant, which Johnson & Johnson’s DePuy Orthopaedics subsidiary manufactured. A number of studies show nearly half of the implants break down and need replacement within six years, as well as having a tendency to shed toxic metal debris in patients’ bodies.

One common complaint about the regulatory process in the United States is that the U.S. Food and Drug Administration allows for devices to be put on the market without clinical testing, based on their ostensible similarity to devices already approved.

In Canada, MacLean’s writes, the problem is a “bottom up” system that allows individual surgeons or nurses to introduce new machinery in their clinics or hospitals with only institutional oversight. As a result, according to the article, “an uncoordinated approach to devices leaves approval processes and pricing all over the map.”

You should consult with a doctor if you have any ongoing symptoms or health concerns from a Johnson & Johnson product. If you have significant injuries, you should also consult with a DePuy hip or transvaginal mesh lawyer to discuss your legal rights.