Fast-Track Approval of Medical Devices Called into Question

The United States is the largest medical device market in the world with sales expected to reach $133 billion by 2016. In most cases, medical devices save and improve lives. Unfortunately, not all devices undergo the same rigorous review process before hitting the market.

A number of new medical devices can and do bypass scrutiny by the U.S. Food and Drug Administration (FDA) through a fast-track approval process called the 510(k) program. If a manufacturer can prove that its product is “substantially equivalent” to an existing product, it can avoid stringent premarket testing. While the 510(k) clearing process provides patients with quick access to new products, there is an unsettling consequence: Medical devices can be implanted in patients without requiring manufacturers to prove safety and effectiveness. And in fact, a recent study published in JAMA Internal Medicine found that only eight of the 50 new devices cleared through the program from 2008 to 2012 included required scientific data.

Defective Medical Devices Raise Concerns

Here are just a few examples of more notable defective medical devices that have caused injury to patients:

Knee and Hip Replacements – Clinical evidence continues to show that the design of some knee and hip replacement implants is seriously flawed. Adverse results include failing to properly bond to the thigh bone, improper placement or loosening after surgery. Bone fractures can occur as well as dislocation of the joint. Symptoms patients may feel range from general pain to swelling to an inability to walk. In 2013, The New York Times reported that Johnson & Johnson knew an all-metal hip implant would fail within five years in nearly 40 percent of patients who had the surgery.

Transvaginal Mesh Complications – Surgical mesh, composed of synthetic materials, is permanently implanted in patients to repair weak or damaged tissue. But in certain procedures it can cause life-changing health complications, including mesh erosion when the device migrates from its point of placement and cuts through the soft tissues of the vagina or pelvic organs. In addition, patients have experienced pain, bleeding and urinary complications, which the product was designed to fix in the first place.

Defibrillator Leads – Defibrillator leads are implantable wires that connect the defibrillator to the heart. In the event of a heart attack, defibrillators automatically administer corrective shocks. Over the past decade, there have been several high-profile examples of defibrillators malfunctioning, causing the device to fire unexpectedly or fail to fire at all when a patient’s life is at risk.

Protect Yourself with These Tips

These tips from Consumer Reports can help protect you or loved ones from the risk of defective medical devices:

1. Consider the alternatives: If your doctor suggests an implant, simply ask what will happen if you don’t get it. Sometimes patients aren’t adequately informed about the alternatives. For example, women who received transvaginal mesh for prolapse repair may not have needed surgery. But people ill enough to require an implantable defibrillator for their heart may not have a choice.
2. Research the device: The Food and Drug Administration’s website, FDA.gov, contains information on device safety warnings, complaints and recalls, which are all accessible by searching the name of the device. Also look for patient forums and other information about the device by searching online.
3. Write down the details: Ask for the brand name, model and serial number (if applicable) of your device so that if you learn of a warning or safety recall, you’ll know whether yours is one of the problem models.
4. Don’t panic: If you learn there are problems with your device, don’t assume that it has to be removed. Contact your doctor and learn to recognize possible negative side effects in your case.