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Articles About Defective Medical Devices

New Bill Aims to Up Transparency of Medical Device Implant Dangers

Medical Device Watch
August 5, 2019

A new bi-partisan bill introduced by Texas Republican Lloyd Doggett in May, 2019 aims ensure that doctors file adverse event reports of defective medical devices. 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.

>>> Read the full article here

Is the Fox Minding the Henhouse?

Medical Device Watch
July 22, 2019

Is the FDA is nothing more than an industry puppet, with medical device manufacturers pulling all of the strings? Likely spurred by increasing public scrutiny, the FDA recently publicized more than 6 million medical device incident reports hidden from the public by device makers over the past two decades through a process known as “alternative summary reporting.” After much public and media scrutiny, this so-called reporting mechanism is finally being phased out.

>>> Read the full article here

What the Heck? Textured Breast Implants Stay on Market Despite Lymphoma Link.

Medical Device Watch
July 18, 2019
Textured Breast Implants and Lymphoma

The U.S. Food and Drug Administration (FDA) announced on April 30, 2019 that they will not ban textured breast implants. This type of implant has been definitively linked to a type of lymphoma called BIA-ALCL. They have been banned in 38 countries including all of Europe plus Canada. Australia will most likely follow suit in short order. 732 cases of BIA-ALCL and 21 deaths have been confirmed worldwide. So, what gives?

>>> Read the full article here

Dangers of Metal-on-Metal Hip Implants

Medical Device Watch
July 12, 2019
Metal-on-metal hip replacements continue fail prematurely and cause metallosis

Although metal-on-metal hip replacements are no longer for sale in the U.S., they continue to cause patient injury and illness. Hip replacement systems manufactured using metal-on-metal fabrication can cause metallosis as well as fail prematurely, requiring revision surgery. This article identifies the device manufacturers at fault and provides information on what to do if you think you are a victim.

>>> Read the full article here

Flawed FDA Process Causes Thousands of Injuries to Patients Each Year

Implanted Medical Devices Not Tested on Humans
July 2, 2019
The FDA medical device approval process

If your doctor has recommended a a hip or knee replacement, he or she may unknowingly be causing more harm than good. Each year, millions of patients are outfitted with a medical device implant such as surgical mesh for prolapse, metal and plastic ball and socket joints for hip replacements, IVC filters for those at risk of clotting, the list goes on. Unfortunately, for many patients implanted with a medical device, the results are far from what they expected. Unlike the pills you get from your pharmacist, most medical devices do not have to undergo clinical testing on humans before being offered to patients.

>>> Read the full article here

FDA releases six million defective medical device records

Hidden adverse event reports secretly filed by device manufacturers now public
June 24, 2019
The FDA released hidden records of defective medical devices

The U.S. Food and Drug Administration has released over 20 years of reports, called "adverse events reports, which documented harmful incidents caused by defective medical devices. Too little and too late, this "program", which allowed some major medical device manufacturers to keep safety issues hidden from patients and doctors, has now been stopped.

>>> Read the full article here

It's Time for a Reckoning on Medical Devices

The New York Times
May 4, 2019
Medical device reporting by the New York Times

When the Food and Drug Administration announced last month that it couldn’t guarantee the long-term safety and efficacy of vaginal mesh products — medical devices that have been on the market for decades — the collective response from tens of thousands of women harmed by the products sounded something like this: Duh." The New York Times Editorial Board recommends three changes to the current FDA approval system for medical devices sold in the U.S.

>>> Read the full article here

Hidden Reports Masked The Scope Of Widespread Harm From Faulty Heart Device

Kaiser Health News
May 21, 2019
Heart Device Defect Lawsuit

Faced with the possibility that a bout of abnormal heartbeats could end his life, in 2006, Dr. Marc Sicklick had a small device implanted in his chest that would shock it back into rhythm. Soon he would struggle with another life-or-death choice: whether to remove the Sprint Fidelis, which was deemed dangerous and recalled in 2007 after it had been implanted in hundreds of thousands of patients.

>>> Read the full article here

You had a knee replacement. It hurts like hell. Now what?

Medical Device Watch
March 19, 2019
Knee Replacement Lawsuits NJ

Over 700,000 knee replacement surgeries are done each year in the U.S., giving many people a renewed ability to live life to the fullest. The overwhelming percentage of knee replacements is successful and patients can expect a lifespan of 15 years or more.

>>> Read the full article here

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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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