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Are Off-Label Uses of Medical Devices Helpful or Harmful to Patient Safety?

Written by Ankin Law Office

Medical devices must obtain approval by the U.S. Food and Drug Administration (FDA) before they can enter the marketplace. Like prescription drugs, over-the-counter medications, and dietary supplements, the product must be approved for a specific purpose. Nonetheless, doctors are allowed to use medical devices in any way that they see fit, including “off-label” uses that expand the use for which the device was approved – a practice that has increased in recent years.

Although some patients benefit considerably from off-label and creative uses of medical devices, as an article in the Star Tribune points out, this “flexibility” comes with a fair amount of risks for patients.

In some cases, negligent doctors might be to blame for the risky use of medical device to treat conditions for which they have not been adequately tested. In other cases, the the lack of federal oversight of medical devices may be to blame. Approximately 90 percent of new FDA-cleared medical devices are approved simply because they are similar to medical devices that are already in the marketplace. Accordingly, the testing and approval process is not nearly as stringent as it is for new devices.  Moreover, the FDA’s oversight extends only to the manufacturers of medical devices, and not doctors.

“Frankly, the oversight is really quite relaxed and not accountable to the public,” said Lisa McGiffert, director of the Consumers Union Safe Patient Project.

Although experimentation of new uses for existing products can lead to medical advances, it can also lead to disastrous results. For instance, certain brands of transvaginal mesh were approved by the FDA based on other similar products that were already on the market. Unfortunately, because the later forms of vaginal mesh did not obtain sufficient medical testing, they were later found to be defective and, accordingly to the Star Tribune, the number of postoperative hospitalizations for complications from vaginal mesh implants more than doubled from 5,448 in 1993 to 12,096 in 2010.

How Our Chicago Injury Lawyers Can Help

At Ankin Law Office, LLC, our Chicago medical malpractice attorneys focus on representing the victims of defective medical devices or medical malpractice in lawsuits against negligent doctors, hospitals, and medical device manufacturers. As a result of our considerable experience and familiarity with medical negligence lawsuits, we can help you pursue the appropriate cause of action and fight to get you maximum financial recovery.

Moreover, our Chicago defective medical device lawyers are committed to promoting patient safety and protecting the victims of unsafe medical devices. If you have suffered injuries as a result of a medical device, such as a hip implant, transvaginal mesh implant, injection pump, or a pacemaker, do not hesitate to contact the skilled Chicago product liability attorneys at Ankin Law Offices at (312) 600-0000 to schedule a free consultation to discuss a possible medical malpractice or product liability claim.

Categories: Medical Devices