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Zimmer Biomet Receives FDA Warning Letter

FDA Warning Letter Zimmer Biomet

On August 24, 2018, Zimmer Biomet received a Warning Letter from the FDA regarding quality violations found during 2016 and 2018 inspections at a facility in Warsaw, IN.

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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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$289 Million Verdict Against Monsanto in First Roundup Cancer Trial

Roundup Cancer Trial

August 10, 2018. After only three days deliberation, a jury came back with a verdict for plaintiff, Dewayne Johnson, in the first trial over claims that the weed killer Roundup causes cancer.

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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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Bayer to Stop Selling Essure Birth Control Device in US

Essure birth control device

Thousands of women have said the Essure birth control device caused serious health issues. On Friday, July 20, 2018 (just days before the release of The Bleeding Edge documentary), Bayer announced that it would discontinue sales of its Essure permanent birth control device in the United States after December 31. This was welcome news to the many women who have advocated against the device.

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Trial to Begin: Zimmer M/L Taper Hip with Kinectiv and VerSys Head

Zimmer trial

Another metal-on-metal hip replacement component is in litigation news: A case involving a woman alleging the Zimmer M/L Taper with Kinectiv Technology hip implant system with a VerSys femoral head was defectively designed and manufactured is set for trial in a Pennsylvania federal court on July 31.

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Considering a Knee Replacement?

Knee Replacement

Knee replacements, like hip replacements, are relatively common procedures to improve one’s mobiliy and quality of life. In fact, total knee arthroplasty (TKA) has become an acceptable method of treating severe arthritis of the knee.

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Pseudotumors: Hip Replacement Complication

Pseudotumors hip replacement complication

Nearly 270,000 primary total hip arthroplasty are performed each year in the United States and may number 570,000 by 2030. Many of these patients experience a successful outcome; however, an unexpected complication for metal-on-metal hip implant recipients to be aware of is a condition called pseudotumors.

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4th of July Firework Safety Tips

4th of July Safety Tips

The 4th of July is just around the corner. It’s a time to gather with family and friends to celebrate our country’s independence. Unfortunately, it’s also a time when serious injuries occur. We want to help you and your family stay safe over the holidays with a few fireworks safety tips.

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Metal-on-Metal Hip Replacement Complications

Metal on metal hip replacement Complications

While all artificial hip replacement devices carry risks including wear of the component material, metal-on-metal hip replacement devices have unique risks in addition to the general risks associated with a hip replacement device.

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