Dangerous, defective and poorly designed medical devices injure thousands of Americans each and every year. While many of these medical devices are necessary to maintain or improve your quality of life, all too often additional health problems arise when a medical device used in a procedure is improperly designed, tested, or manufactured.
A few commonly seen cases involving defective medical devices are:
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If you or a loved one has been injured by a defective medical device in any way, call the experienced attorneys at Robins Cloud today to get the assistance you deserve.
Medical devices function to save and improve the lives of people across the globe. Sadly, some devices turn out to be defective, leading to new health issues and, possibly, even death. This occurs when a faulty design prohibits the device from working as intended or when one or more parts of the product are contaminated during manufacturing. As a result of the defect, the patient may find they need to undergo further treatment, often in the form of surgery, and some die as a result of the product being used. Individuals need to understand all risks when they are provided a medical device and alert their doctor to any problems they experience.
Defective Medical Products
Unfortunately, not all medical devices undergo adequate testing before they reach the market and, as a result, some patients have been injured. Those who find they have been the victim of a malfunctioning device may find their life is changed forever as a result of these injures. Although extensive testing is done as a part of the United States Food and Drug Administration approval process, the manufacturer is the one who is ultimately responsible for making certain the product is safe for use. If they fail to let the public and the Food and Drug Administration know about any problems detected with the product, they are considered to be negligent. They then become liable for the person’s injuries, any illnesses the patient develops as a result of use of the product, or any deaths that occur.
Where Problems Arise
Medical devices often work properly for a period of time. When they do malfunction, the patient may find they suffer from a number of symptoms as they wait for corrective measures to be taken. These measures may not always be effective, which can lead to a new set of issues. Patients need to be aware of this and alert their doctor to any new symptoms they are experiencing, how frequently they occur and when the patient notices them, and the duration of the symptoms. This helps the doctor determine where the problem lies and whether the medical device may be involved. Following are some devices that have already been identified as defective in one or more ways.
Hip And Knee Replacements
The FDA created a special 510(k) program for the approval of hip and knee replacements, and this program allows a device to be cleared through the program and brought to market simply by establishing it is substantially equivalent to one or more devices already in use. As a result, more and more patients are receiving devices that have yet to undergo adequate testing. Certain types of these devices, such as metal-on-metal replacement hip devices, have been shown to fail at a very high rate. The same is true of many artificial knee replacement devices that never properly bond with the bone in the thigh.
As a result of these defects, the joint can slip out of alignment and bring about bone dislocation and/or fractures. The joint may swell or become painful, and the patient may find they aren’t able to walk. When this occurs, one or more surgeries are often needed to rectify the problem. Patients preparing to have a knee or hip replacement and those who have already gone through one or more of these surgeries need to recognize the dangers of defective medical products and watch for signs of any problems.
Transvaginal Mesh is a device used to treat stress urinary incontinence or pelvic organ prolapse (POP). Synthetic plastic makes up this device, which appears to be a net with very small holes. When treating pelvic organ prolapse, surgeons insert the medical device transvaginally to support the bladder, bowels, and uterus and make certain they do not descend into the vagina. For those suffering from stress urinary incontinence, the transvaginal mesh works to support the urethra and prevent urine from involuntary leaking. Unfortunately, almost 4,000 patients reported adverse effects with use of this product between 2005 and 2010.
Upon receipt of these reports, the FDA opted to issue a Public Health Notification alerting consumers to serious complications associated with these devices, yet stated the adverse effects weren’t common. Three years later, in 2011, they chose to change the alert, stating one in ten patients who underwent surgery in 2010 experienced side effect. This included severe pain while performing normal, everyday activities and while having intimate relations, recurring infections, organ perforation and more. In excess of 30 manufacturers of transvaginal mesh were then required to complete a safety review of these devices, and more than 73,000 lawsuits have now been filed.
Women turn to birth control to prevent unwanted pregnancies, yet often end up with unwanted side effects. For example, an intrauterine device known as Mirena has been show to cause device expulsion and organ perforation in certain women, with more than 45,000 women reporting problems with the device. Although this device continues to be offered, the FDA alerted Bayer, the maker of Mirena, to false or misleading information in their ads and stated the company didn’t warn users of all complications. NuvaRing, another form of birth control, carries the risk of life-threatening blood clots in users. The FDA required changes to the product’s safety label in 2008 and followed up in 2011 with another warning about the danger of a woman developing venous thrombosis or blood clots that may make their way to the lungs. Women need to understand the risks of various birth control methods when deciding which one is right for their needs, yet this can be difficult when manufacturers don’t share the information they have.
These are only a few of numerous examples of medical devices that malfunctioned and led to serious complications. There are countless others, and individuals need to recognize that simply because a product is offered does not necessarily mean it is safe. Anyone who believes a medical device that are using or have used in the past is the cause of their issue needs to speak to an attorney to learn more about their legal options. The devices are intended to better the lives of the user. When they fail to do so and the manufacturer is aware of the issues, the company must be held responsible. We ensure they are. Call us today to discuss your case and how we may be of help to you.
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