Medical Review

Did You Experience an Adverse Reaction to a Medical Device? Here's What You Can Do

It is always exciting when new medical treatments and devices get the green light to go on the market. That means that many people who have mild to life-threatening medical conditions can get health problems under control – and in many cases, the devices can be genuine lifesavers.

Unfortunately, the results can be disastrous when the treatment or device turns out to have some major defect. If you or a loved one endured an adverse reaction to a medical procedure or device, perhaps legal action is a worthwhile option for you. Even though many patients might have had positive responses to certain devices, that is small comfort to those who also used the device and encountered significant health problems or who tragically die before their time. Questions have emerged regarding a variety of health devices and treatments such as the link between asbestos exposure and mesothelioma, implanted heart defibrillators and transvaginal mesh patches and others. For more information about medical lawsuits, check our articles about medical matters.

For many people who have suffered a seriously adverse reaction to a medical device or treatment option, the only recourse is through the courts. A civil lawsuit can produce financial compensation if the plaintiff wins. Financial compensation cannot replace a human life or permanently impaired quality of life. It can, however, provide some help for people whose health problems were heightened due to faulty medical devices. It also can offer some sense of justice and closure to bereaved loved ones.

Medical Devices and Treatments: What to Look For

There are times when it pays to be a well-informed consumer, especially when it comes to such things as any kind of medical treatment or any device surgically placed in your body that is supposed to help improve your health. Manufacturers strive to provide excellent products, but there are occasions when different items or treatment methods turn out to be defective despite all the precautionary measures a company might take and all the regulatory checks provided by government.

It sounds tedious, but it is wise to plow through the patient prescribing information document that comes with medical devices and medicines in general. By law, these are supposed to clearly spell out any potential side effects, and a well-informed patient would be smart to discuss these with the doctor prescribing the treatment. Medical devices that are incorrectly labeled or which have been shown to produce adverse effects in clinical studies can be dangerous. Another disturbing issue is the possibility that manufacturers who knew a device could be faulty withheld that information to the correct regulatory agencies.

FDA Information
It might take patience, but it also is worthwhile to go through the U.S. Food and Drug Administration's website. The FDA generally informs doctors and the public using public health advisories, safety alerts and warnings if any new information has been discovered regarding a medical device. It would not hurt to visit the website and see the regulatory history of any device you are considering using.

News Reports
This might seem an unusual recommendation, but reputable news outlets can be a trusted source for learning about medical discoveries. Serious flaws with certain Guidant-made implanted heart defibrillators came to light through a series of New York Times articles in 2005 that may have prompted the company to announce a voluntary recall for these products. As a consumer of health care products, it is essential to stay well informed and discuss fully what you have learned with your own physician who, hopefully, stays abreast of new developments in medicine.

Of course, not all medical research firms are negligent or deliberately attempting to harm people. Without their extraordinary scientific advances and the modern treatments and devices they produce, patients worldwide would not have all the medical treatment choices and opportunities for better and longer lives that they enjoy today. This is especially true when compared to previous generations.

In addition, not every device will work for every patient and it is a given that we all must accept a certain level of risk with any medical treatment. No medical device is without some kind of side effects and potentially negative reactions, and patients must discuss these with their doctors to weigh the risks and benefits before embarking on any treatment regimen.

Nonetheless, there is plenty of documentation to support the fact that serious health problems can result from medical devices. Even more troubling is when doctors, the general public and patients are not told about the negative side effect that could produce results that range from unpleasant to life threatening.

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Mesothelioma, a type of lung cancer, has been strongly linked to asbestos exposure. Although asbestos-containing materials were widely used throughout the United States for a number of decades, most are now forbidden. Numerous lawsuits regarding asbestos exposure and mesothelioma have been settled. . . Read Our Full Review
Fentanyl, a brand name for the powerful pain-killing drug fentanil, is a useful medication for patients who are experiencing extraordinary pain. However, some individuals allege that certain Fentanyl patches were defective and produced. . . Read Our Full Review
The DePuy Pinnacle hip implant was supposed to be a durable device to help individuals who suffered from painful hip ailments. However, some have filed lawsuits claiming that the product created greater pain and other serious side effects such as high levels of cobalt and chromium in the. . . Read Our Full Review
The Stryker ABG II modular-neck stem hip implant came onto the market in 2009. However, Stryker Orthopaedics recalled the device in 2012 after due to "potential risks associated with fretting and corrosion" that could lead to adverse tissue. . . Read Our Full Review
The Stryker Rejuvenate modular neck stem hip implant was approved for sale in 2008, but Stryker Orthopaedics recalled it in 2012. The company stated that fretting and corrosion could produce "adverse local tissue. . . Read Our Full Review
Zimmer Durom Cup hip implant has been available in the United States since 2006. Numerous patients alleged they had developed serious pain in the hip area and needed revision surgery, although Zimmer said physicians needed different training to implant the device. . . Read Our Full Review
Zimmer NexGen LPS-Flex knee implant has been a choice surgeons sometimes preferred for patients with knee problems, including such things as osteoarthritis and rheumatoid arthritis. However, a number of patients have alleged that the implant failed in their. . . Read Our Full Review
NuvaRing is a small plastic vaginal ring that a woman can insert into her body as a contraceptive device that slowly releases hormones, providing convenience and effective birth control. However, many patients have alleged that NuvaRing poses a higher risk of blood clots, deep vein thrombosis and. . . Read Our Full Review
American Medical Systems, like a number of companies, manufactured transvaginal mesh patches that were surgically implanted into female patients to fix problems with tissue that will not stay in place. However, a number of patients have alleged that the patches have caused serious pain, perforation. . . Read Our Full Review
Johnson & Johnson has manufactured transvaginal mesh patches, as did many other companies, which were surgically implanted into a woman to correct problems with tissue that will not stay in place. However, many patients have alleged that the patches caused infections, severe pelvic pain and. . . Read Our Full Review