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New Bill Aims to Up Transparency of Medical Device Implant Dangers

Medical Device Watch
August 5, 2019

Our paints are tested for lead, our food gets certified as safe for consumption, and new drugs undergo laboratory and clinical trials before being cleared by the FDA.  Yet millions of medical devices like breast implants, hip replacements, and surgical mesh are implanted in patients each year with absolutely no human testing.  And shockingly, if these products are found to be defective, doctors are not even required to notify the FDA so that others can be warned of the dangers. 

A new bi-partisan bill introduced by Texas Republican Lloyd Doggett in May, 2019 aims to change all that.  The Medical Device Guardians Act (H.R. 2915), will require physicians to file an adverse event report with the FDA if they encounter a patient who has complications from a medical device implant. Lawmakers are hopeful the new legislation will increase the transparency of medical device dangers so patients can make more informed decisions on whether a medical device implant is worth the risk.  

“Alternative summary reporting” protracts veil of secrecy for medical device implant dangers.

For certain types of medical devices, the FDA allows manufacturers to avoid reporting individual adverse events through the “alternative summary reporting program.”  As a result, manufacturers are only required to submit a quarterly spreadsheet that summarizes commonly occurring problems with a specific medical device implant.  As a result, devices like textured breast implants, now linked to a form of lymphoma called BIA-ALCL, have been allowed until very recently to stay on the market despite the FDA being alerted to problems as far back as 2011.  

While a growing number of investigations into the flawed FDA process have increased scrutiny on the approval and reporting process, change is slow and loopholes remain.  Similar legislation has been proposed in the past, but the medical device industry has staved off scrutiny through generous contributions to political campaigns and bankrolling of Capitol lobbyists.   

Millions of patients potentially injured because FDA reporting system failed to timely warn of dangers. 

For those concerned about the safety of certain medical device implants, the FDA instructs patients to search its Manufacturer and User Facility Device Experience (MAUDE) database for specific device warnings.  But because of the lag between patient reporting and the FDA notifying consumers of potential risks, patients may not receive warnings in time.  

In response the shortfalls of the MAUDE reporting system, private databases, such as Device Events, have been developed in an effort to better identify and track medical devices that may be faulty. Unfortunately, patients who underwent surgery before the existence of warning systems like Device Events, were cheated of the chance to make an informed decision about the potential benefits and risks associated with their medical device implant.

What should you do if you’ve been injured by a medical device implant.

Injuries from medical device implants have been known to plague patients with chronic pain, permanently disabling conditions, and even death.  If you’ve been injured by a medical device implant, your first priority is to regain your health.  You can then ensure that others are warned of the risk by reporting your adverse event through the FDA’s voluntary MedWatch reporting system. 

No sum of money can adequately compensate for the ongoing pain, disability, and loss of enjoyment that you may have experienced due to a faulty medical device implant. However, the collective filing of claims against manufacturers sends an important message to the medical device industry that their exploitation of patients will not be tolerated. 

If you are thinking about taking legal action for your injuries, you should talk to a law firm experienced in product liability claims as soon as you feel able.  Often times potential claims are subject to a statute of limitations (a set number of years you have to file a claim after discovering your injuries). 

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Medical Device Watch is sponsored by Wilentz, Goldman & Spitzer, P.A. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.

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