Medical devices may not be fully tested before use on patients

A new investigation by Consumer Reports reveals some shocking truths about the medical device industry. Many of us probably assume that if a doctor recommends an implant device, that it will be safe and effective. However, the report indicates that FDA testing for medical implants is not a rigorous as other medical products such as pharmaceuticals. In fact, many devices are introduced into the market without a complete clinical trial.

Advocates say that this means the trial is essentially conducted on the unsuspecting patients who get the product implanted, and the dangers are often not known until many people have been injured. One example of a defective medical device that has caused harm is a metal hip made by Johnson & Johnson.

The FDA cleared the product without clinical testing because it was very similar to other devices that the company had manufactured and sold in the past. This is one way that many dangerous medical devices end up on the market without warning to consumers.

The hip was being touted as a big improvement for implants over previous versions, since it was entirely metal rather than metal and plastic. However, it was later revealed that all-metal implants can lead to what one doctor called “profound poisoning.”

The product was recalled five years after it went on the market, affecting about 93,000 patients.

Liability for the injuries often falls to manufacturers in these cases, although other parties may be implicated if they were aware that the device was dangerous. Even if a product was not recalled, the manufacturer could still be liable.

Source: Consumer Reports, “CR Investigates: Dangerous medical devices,” May 2012.