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Medical device recalls are on the rise, with patients reporting injuries and problems from defective products more often than ever. The most serious of all FDA recalls is known as a Class I, since that indicates a situation where there is a reasonable chance that exposure to or use of a product could lead to major health consequences or death.

The FDA recently completed a research project and report to explore the upward trend of defective device recalls. While there were only 7 defective device Class I recalls in 2003, that number increased to 52 in 2012. When a firm submits a correction or recall of a product to the FDA, the company is responsible for reporting the injuries and deaths at that time. Deaths were reported by 25 percent of companies involved in Class I recalls.

The FDA identified the six most likely kinds of devices to be recalled. These included infusion pumps, automated external defibrillators, ventilators, blood glucose and other system tests, catheters, and implanted pumps.


New data shows that a company manufacturing cochlear implants distributed defective products to adults and children for many years. Unfortunately, this is just one example of defective medical devices that cause injury to people all over the world.

The second largest manufacturer of cochlear implants across the globe, Advanced Bionics, knew that there were issues with their HiRes 90K implants from the beginning. Early users of the product discovered shocks and pain and excess moisture inside the implants. Sadly, some of those early users are still feeling the impacts of defects today.

One such patient is Grace Bagadiong. Grace has an undiagnosed medical condition that has taken away her ability to use her arms, walk, or breathe on her own. As a toddler, Grace became totally deaf. Her doctors recommended a cochlear implant surgery as the only route for Grace to ever hear again. In 2005, Grace received a HiRes 90K implant, but her parents received a surprising letter just a few months later. The letter explained that Grace's implant was being recalled after numerous failures were reported, including patients who were shocked in the head by the device.


Sometimes the medical devices meant to keep you alive are more dangerous than the condition they are meant to alleviate. When Thoratec introduced its HeartMate II monitor with pocket control, patients across the U.S. lauded the introduction as an easier way to deal with a debilitating condition. Yet in early March, the Thoratec Corporation “issued a safety advisory because some patients and caregivers have experienced difficulties with the process of changing from a primary system controller to their backup system controller,” according to the Food and Drug Administration (FDA) Safety Watch.

There were nine events that led Thoratec to issue the warning. Included in these nine were reports of four deaths and five incidents of unconsciousness and hypoperfusion. Two of the deaths, however, occurred in patients who attempted to change the device on their own without first contacting the hospital, as per the unit instructions. Yet even medical professionals were having trouble changing to the backup, which in part led to the other three deaths, according to the FDA.

HeartMate II is implanted to patients at severe risk of heart failure. The HeartMate II Pocket Controller, according to the Thoratec website, is the “only lightweight, pocket-sized LVAD controller that safely and smartly enables an active lifestyle for HeartMate II patients. Figures are not yet available as to how many patients have been issued the pocket controller, but according to Thoratec, there are approximately 15,000 patients who have had the HeartMate II implanted for the “long-term support of advanced heart failure.”


Artificial joints fail 10 percent of the time, according to the Consumer Reports Safe Patient Project. Surgical mistakes, complications, and product defects can all make a patient's life more difficult.

Every major hip and knee implant manufacturer has recalled a product in the last ten years. Sadly, if you have been the victim of a faulty implant, you and your insurance might have to foot the costs of your medical expenses in the short term.

While some symptoms appear right away, others might not begin to bother a patient until several months later. Common symptoms of a failed implant include swelling, stiffness, instability, and general pain. Metal implants that break down over time can cause serious pain for patients. Joint surfaces rubbing against one another can wear down the implant surface, causing loosening and bone loss.


Posted on in Defective Medical Devices

The FDA-approved warning label for Mirena, an intrauterine system used by thousands across the country, lists critical side effects including perforation, embedment, expulsion, ovarian cysts and breast cancer. Additionally, women who become pregnant while using Mirena could miscarry. Mirena patients have reported a wide range of minor and major side effects, leading to defective medical device lawsuits.

A Detroit news station found that over 2 million women use the product, and the FDA has seen more than 70,000 complaints between 2008-2013. The reported issues have been on the record for years, with women suffering from regular pain, some requiring surgery, and others suffering from infertility as a result of their use. More minor complaints included back pain, headaches and acne, while others continued to suffer serious impacts after using Mirena. 4,775 women reported about device dislocation, where Mirena migrated outside of the uterus or became embedded in the uterus. Nearly 4,000 women noted issues with serious abdominal pain, and a further 1300 Mirena users experienced perforation of the uterus.

Mirena is promoted as an improvement over traditional birth control pills since patients do not have to remember to take medication each day, and it therefore reduces the chances of accidental pregnancy. However, the downside of this IUD is that patients may suffer painful symptoms without realizing that the device is no longer safe or is even serving its original purpose. Patients who are experiencing adverse side effects like those noted above need to seek medical and legal advice about their next steps.

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