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Medical Devices

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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FDA Restrictions Placed on Essure

Essure FDA Restrictions

Permanent birth control is one of the most widely used methods of contraception today. It can be highly effective, doesn’t require a surgical procedure and women no longer have to remember to take a daily pill. So why has the FDA restricted the sale and distribution of the Essure device and required boxed warnings?

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Gaining Market Approval for Medical Devices

FDA Market Approval

It is the responsibility of manufacturers to ensure the products they bring to market are safe for public use. While the US FDA reviews the products before going to market, what do medical device manufacturers do to gain market approval?

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Do IVC Filters Make a Difference?

IVC Filter lawsuits

A new study, published in the scientific journal, JAMA Surgical on September 28, 2016, suggests that IVC filters may not help people who are at risk of dangerous blood clots to improve their chances of survival.

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