Over the last two decades, the U.S. has recalled 26,700 medical devices, according to Mexicanos Contra la Corrupción y la Impunidad – a team of journalists in Mexico City working in association with the International Consortium of Investigative Journalists. The reason these Mexican journalists are on the case is because these recalled or defective medical devices usually end up back in Mexico.
Reporter Miriam Castillo is one of the reporters on that team, and says Mexicans most likely won’t know that these devices – which include pacemakers and orthopedic implants for people with damaged bones or joints – could be harmful because the Mexican equivalent of the U.S. Food and Drug Administration rarely recalls products.
“We only had two recalls in almost 20 years,” Castillo says.
She says her team found that in Mexico, people generally don’t have a lot of information about products or devices that may be unsafe.
Another issue is that many of the failing devices are originally assembled in Mexico; the ones that are shipped to the U.S. are regulated by the FDA, but the same products that will end up in the Mexican market are poorly regulated.
“It’s like two processes,” Castillo says. “Sometimes in a same factory, there’s a line for the products that are going to export to the FDA and the United States and another country, and there’s another line in which they make the devices that are selling here in Mexico. The processes are different, the quality [is] different, also the personnel isn’t enough.”
In their project, called “Implant Files,” the reporters found that Mexico isn’t the only country with lax medical-device regulation. Only a handful of countries do regulate, including the U.S., Canada and Brazil. She says many countries don’t regulate medical devices because the device companies are influential, and can lobby to limit government oversight. Her team also found evidence of corruption.
“There were bribes,” Castillo says. But she says Mexico doesn’t punish the companies in those cases.
In the U.S., injured patients can file class action lawsuits against medical device companies, but Castillo says Mexican patients cannot join these suits. She says the law in Mexico makes it hard for patients to prove that their injury was the fault of the device.
“You have to prove it and it’s complicated,” Castillo says. “Generally, if something fails, the company comes to the hospital and gets the device … so the evidence is hard to get.”
Written by Caroline Covington.