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Medical Devices

Medical Device Recall FAQs



A medical device recall is when the manufacturer either removes a device or takes corrective action to address a problem with a device that is in violation of the FDA laws, such as when the device is defective and/or a risk to health.

These are some basic FAQs and resources to help you understand medical device recalls.

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FDA Orders Two to Stop Selling Pelvic Mesh, Citing Safety Concerns

FDA in magnifying glass

Surgical mesh has been used to treat hernias since the 1950s. In the 1970s, gynecologists began using it for abdominal repair of pelvic organ prolapse (POP) and in the 1990s for the transvaginal repair of POP.

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FDA’s Hidden Reports on Medical Devices

FDA Hidden Reports

March 8, 2019. In an article published by Kaiser Health News, we learned that some medical device manufacturers have been using a secret reporting mechanism to let the FDA know of problems with their devices.

The problem? The data is hidden so that neither the public nor doctors are aware of any problems reported.

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Implant Files: A Global Investigation of the Medical Device Industry

Implant Files Investigation

In 2018, the medical device industry and the FDA came under fire from:

  • The powerful Netflix documentary, The Bleeding Edge, which chronicled the pain and suffering caused by complications of medical devices with little or no testing.
  • The Implant Files, a year-long investigation by the International Consortium of Investigative Journalists focused on the medical device industry and its overseers.

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Essure Device: FDA Safety Oversight after Discontinuation of US Sales

Essure FDA Oversight

December 20, 2018. FDA Commissioner, Scott Gottlieb, issued a statement on the new steps the FDA will take to strengthen the long-term safety oversight of Essure.  In his statement, Gottlieb said the FDA will continue to evaluate the product’s long-term safety profile even after it has been discontinued in the US market.

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FDA to Overhaul Medical Device Review System

FDA Overhaul of System

“Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of medical devices.”

On Monday, November 26, 2018, the Food and Drug Administration announced that it plans to modernize its current process, the 510(k) clearance pathway, which is how a majority of the medical devices are reviewed and approved by the FDA today.

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Are These Medical Devices Safe?

Medical Device Safety

The documentary, The Bleeding Edge, has focused some much-needed attention on the medical device industry and the process to bring these devices to market.

The film documents the following four medical devices, raising the question as to how well our system is working in regulating medical devices.

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Regulating the Medical Device Industry

Medical Device Approval

Medical devices, many of which save lives every day or give us a better quality of life, are everywhere.

Over the past 10 years, nearly 70 million Americans have been implanted with medical devices.
– Jeanne Lenzer, The Danger Within Us [quote from The Bleeding Edge]

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The Bleeding Edge Chronicles Medical Device Complications

Medical Device Complications

Have you heard of the documentary, The Bleeding Edge? It chronicles the unnecessary pain and suffering of patients caused by complications of medical devices that received little or no testing.

Available on Netflix, this documentary is extremely powerful. It is worth taking the time to watch and share with everyone you know especially if you will be undergoing an expensive or risky medical procedure.

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Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices

FDA Market Approval

FDA Letter to Health Care Providers

Posted by the FDA on April 25, 2018.

The Issue: FDA is providing preliminary information concerning magnetic resonance (MR) thermometry reliability with magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) devices.

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