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There is no shortage in advertisements seeking those who have been injured during the use of medications or medical devices. As a result, the FDA is pushing for stronger guidelines when it comes to the postmarket surveillance of these products in an effort to reduce the number of defective devices used by patients.

The reason for this action is to lower the number of recalls and reduce injury to patients. Postmarket surveillance is important because most drugs are approved based on clinical trials of the products. Clinical trials apply to a small control group that are selected by the manufacturer. This control usually does not have other medical ailments besides the one that the drug is designed to treat. Yet this will not be true of the general populous.

Postmarket surveillance then continues to monitor the performance and safety of the drug or product once it is released to the general populous who may have addition and varied medical conditions. Information is gathered through various databases, event monitoring for prescriptions, and patient registries. It is then gathered and compared through data mining and will be further be reviewed to uncover any potentially dangerous safety concerns.


While all of the different artificial hip implants on the market carry some form of wear risk, those that are made with metal-on-metal are some of the most dangerous out there. This is because of their unique structure, and these additional concerns can create problems and pains for patients who have had them installed.

In these hip implants, the metal cup and metal ball slide against one another while the patient is walking or running. As a result, small metal particles can be released into the body of the wearer. Corrosion at this connection is also cause for concern, because the small metal particles that have been corroded may release these materials into the bloodstream. Sadly, too many metal hip implant patients learn this too late. The FDA notes that there is actually no way to prevent some metal particles from being produced as a wearer uses their device.

There are reports in orthopedic literature and from international agencies about the dangers of these hip implants, and yet doctors still continue to use them for patients in need of hip replacement. Many patients who have received metal-on-metal hip implants have experienced some problem afterwards, and some of those cases required revision surgery. Between noticing the problem and getting the surgery, some patients continued to suffer.


Pharmaceutical giant GlaxoSmithKline has come under fire in recent years for paying doctors to promote drugs, according to Mercola.com. The practice is, surprisingly, a legal one, and “widespread in the drug industry.” At the end of 2013, however, Glaxo announced that it would stop the practice, as well as stop “compensating its sales representatives based on the number of prescriptions that doctors write,” according to Mercola. One such drug promoted by Glaxo to doctors was Avandia, a diabetes pill that was banned in Europe in 2010.

In 2011, according to Bloomberg News, GlaxoSmithKline “agreed to pay $3 billion to resolve U.S. criminal and civil investigations into whether the U.K. company marketed drugs for unapproved and other matters.” Despite the fact that Avandia had been banned in Europe, the FDA did not do so, though access to the drug was restricted. At the end of last year, however, several of those restrictions had been removed, according to a different Mercola article.

According to Mercola, Avandia leads to a 43 percent increase in risk of heart attack, and “a 64 percent higher risk of cardiovascular death than patients treated with other methods.” The study that led to the approval of restrictions being lifted was conducted by GlaxoSmithKline at the request of the FDA.


Consumers and patients who have been in injured by defective devices or other unsafe products frequently report these issues to the FDA, as they should. Recent cases relating to defective medical devices as well as products outside the realm of healthcare demonstrate that while it's the federal government's job to investigate these claims and promote safe standards across the board, this process is often a lengthy one.

In some cases, manufacturers appear to act as if they can get away with unsafe products, leaving individuals at high risk while continuing to make a profit. In terms of medical devices, heart defibrillators, vaginal mesh implants, and knee and hip implants are just a few examples of products that were designed to help actually harming patients.

In the consumer sector, both GM and Toyota have recalled high numbers of automobiles after serious reports of driver injury and even death. In all these cases, the government frequently finds that the manufacturer knew about the dangers long before a recall or product fix was implemented.


Finding out that you or a loved one has suffered injuries or requires additional procedures to correct problems from a defective medical device is frustrating. There are certain steps you need to take to protect yourself and to have the best chance of getting the company to recall or fix defective devices.

The Corporate Whistleblower Center believes that defective medical devices are a problem more pervasive than many people realize. Recent reports from the Justice Department show that heart defibrillators made by Guidant post a serious risk to those using them. The company manufactured Prizm 2 and Renewal 1 and 2 devices that led to a problem known as arcing. The device will detect an irregular heartbeat and administer a shock, but then the electrical pulse will arc back to the device, too. When this happens, the device actually short circuits and becomes ineffective, leaving the user at high risk.

Recent government investigations reveal that some of these companies were aware of the defects in their products long before any of those details were made public. In this case, Guidant appeared to continue selling those same products even though some changes were made to the original model.

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