Product News and Recalls

Investment advisor faults medical device makers

In a Motley Fool article for MSNBC, Sara Wright recommends against investing in manufacturers of dangerous medical devices that made it onto the market through a regulatory loophole.

“I cannot see clear to investing my money in companies that do not take the safety and efficacy of their products more seriously,” she writes.

Among the companies she spotlights are Johnson & Johnson, owner of a subsidiary that made metal-on-metal hip implants. She also mentions Boston Scientific, maker of a surgical mesh designed to support internal organs.

Both products were approved through regulations that require the FDA to approve medical devices that weren’t subjected to clinical testing, based on their alleged similarity to products already on the market – even if the original products were eventually recalled because of safety concerns.

Wright expresses hope that the FDA will eventually tighten the requirements for device approval. But even if it does, she believes the fact that the companies exploited the loophole in the first place doesn’t reflect well on them.

“There is clearly a thread through these stories,” she writes. “If medical device manufacturers were high school kids in the basement with a keg, the FDA was the parent who went upstairs and trusted the teens to holler if there was a problem. But these companies are not children, and I expect better from them.”

According to Wright, Boston Scientific had a mesh product designed to repair internal hernias, and tried to get approval for the product’s vaginal use to treat urinary incontinence. Even though it affected a different body part and required a different implantation method, it went straight to market without clinical testing in humans.

One study found that 15 percent of vaginal mesh recipients suffered complications including debilitating pain and organ perforation, and that the mesh benefited them no more than alternative treatments.

And the Johnson & Johnson subsidiary, DePuy Orthopaedics, used to make hip implants from a combination of plastic and metal, but switched to an all-metal design. Again, the device went straight through the clearance process without testing because of its ostensible similarity to the previous model.

Nearly half of all the metal-on-metal hip implant recipients needed a second surgery within six years to repair the damage, and DePuy only recalled the device after almost 100,000 people had already served as unwitting test subjects.

If you’ve received either of these devices, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a lawyer familiar with the DePuy hip implant or transvaginal mesh case to discuss your legal rights.

See the article here.