Posted by Elaine Gray on April 1, 2015.
Countless patients around the world depend on advanced medical devices to improve their quality of life. As the $110 billion medical device industry cranks out thousands of products every year, eye-opening reports continue to surface detailing faulty devices, repeat surgeries and massive recalls. The FDA argues patients need access to life-saving devices quickly. However, a speedy approval process means some risky devices are cleared without clinical testing, and once on the market receive limited oversight. You should know the risks and realities of medical devices before one is put in your body.
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.
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.
These tips from Consumer Reports can help protect you or loved ones from the risk of defective medical devices: