Posted on April 15, 2014 in Defective Medical Devices

A new report from the Food & Drug Administration's Center for Devices and Radiological Health says that defective devices have spiraled out of control in the last decade. Between 2003 and 2012, device recalls have increased by 97 percent. Defective medical devices have caused injuries, pain, and complications for patients who use them.

The report indicates that the most common causes for recalls are software problems, nonconforming material, component issues, or device design defects. The government agency put most of the responsibility on device manufacturers, saying with some careful inspection and research it could be possible to prevent up to 400 recalls every year.

The FDA has increased its focus on the medical device industry after numerous complaints and allegations indicated a string of problems with devices. Some patients discovered too late that devices didn't work properly, putting them at risk of injury or death.

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 Posted on April 10, 2014 in FDA

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.

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 Posted on April 07, 2014 in Defective Medical Devices

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.

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 Posted on April 03, 2014 in Birth Control

According to Fox News, more than 3,600 women have joined together to file an unsafe medical drug lawsuit against drug manufacturer Merck. According to the lawsuit, more than 100 women have died as a result of using the company's contraceptive, NuvaRing.

Lawyers associated with the suit argue that the contraceptive ring caused blood clots that resulted in death. They also state that Merck failed to include the risk of clots on the medication label and did not inform doctors that NuvaRing carries a clotting risk that is up to five times greater than traditional birth control pills.

NuvaRing uses a different type of progestin than what is contained in other birth control medications. Desogestrel and its related compounds carry fewer side effects (such as acne) than birth control pills but carry a higher risk of blood clots. According to research in the British Medical Journal, vaginal rings also carry a 90 percent greater risk of venous thromboembolism (a blood clot that blocks a vein).

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 Posted on March 31, 2014 in Defective Medical Devices

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.

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 Posted on March 27, 2014 in Dietary Supplements

The U.S. Food and Drug Administration (FDA) regulates that drugs are on the market and enforces recalls when enough substandard performance, undeclared ingredient, or adverse side effect reports are received. According to the FDA, “recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.” There are three types of FDA recalls—Class I, II, and III. A Class I recall is the most severe, and issued when a product or device is likely to have severe adverse health effects. A Class III recall is issued when a product or device is not expected to have immediate health consequences, but has the potential to be so later. A safety alert is issued “in situations where a medical device may present an unreasonable risk of substantial harm.”

Oftentimes, when the FDA cannot recall a product, the organization will issue a warning that encourages consumers to dispose of it instead. In early March, the FDA issued such a warning about Weekend Warrior, a dietary supplement for men to increase sexual performance. According to Forbes, the drug was recalled “because it is adulterated with thiosildenafil, a chemical analogue of the active ingredient in the erectile dysfunction drug, Viagra.” The drug is sold primarily online, but is also available in select retail stores.

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 Posted on March 25, 2014 in Defective Medical Devices

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.

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 Posted on March 19, 2014 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.

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 Posted on March 19, 2014 in Defective Medical Devices

Consumers are likely familiar with warranties offered any time a purchase is made for a new appliance or electronic. But what about surgeries for replacement body parts? Although one million individuals receive hip or knee implants every year, only one manufacturer offers a warranty, and this warranty is only on a partial knee implant.

Lisa McGiffert, director at Consumer Union's Safe Patient Project, believes that manufacturers should provide patients with a 20-year warranty on all implants. This warranty would entitle patients with defective hip and knee implants to obtain total replacements at no cost. McGiffert says that higher numbers of younger people are getting these implants and those getting implants in the older population do so to maintain an active lifestyle, thus highlighting the importance of product safety and longevity.

Consumers Union has data showing that nearly 20 percent of hip replacements and almost 10 percent of knee replacements require additional surgeries to correct defects. The additional surgeries wind up costing patients and insurance companies hundreds of millions of dollars. McGiffert believes that this increased cost should not fall on anyone else's head but the companies who make faulty replacements.

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 Posted on March 16, 2014 in Defective Medical Devices

More research has come out recently that links testosterone therapy to heart conditions. A study published in early January of this year found that men taking testosterone drugs faced a higher risk of heart attack for men over the age of 65. Men younger than 65 but with a history of heart problems also had higher risks for heart attacks, according to the study tracking 56,000 men. Serious medical complications from treatment or medical devices can cause an array of complications or injuries.

The study looked at men between 2008 and 2010, finding that the heart attack risk for men doubled when participating in testosterone therapy. Previous studies had only looked at older men using a high dosage of testosterone gel, although a November 2013 Veterans Affairs study also identified a 30 percent increase in heart attacks, death, and strokes for more than 1200 men taking the testosterone drug.

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