Defective Devices

Hernia Mesh Attorneys

First Physiomesh Bellwether Trial Will Start This Year

Back in May 2016, Ethicon recalled its Physiomesh hernia mesh after reports determined recurrence and reoperation rates were higher than average. Following these reports, many patients who had been implanted with the defective mesh filed lawsuits seeking compensation.

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510(k) Approval Process

What’s The FDA’s 510(k) Approval Process and How Does It Hurt Patients?

Most people believe that any medical device available on the market goes through a thorough and effective approval process. The truth is, this is not always the case. The U.S. Food and Drug Administration (FDA) is charged with analyzing new device applications and granting approval to reasonably safe devices; however, the agency has more than one avenue for approval. In addition to the ordinary application process, the FDA has an approval process called 510(k) approval and it’s putting many patients at risk.

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Medtronic Defibrillator Lawyer

Medtronic Defibrillators Facing More Problems

Patients with Medtronic Defibrillators already know firsthand how defective these devices can be. In addition to previously known issues, the U.S. Food and Drug Administration (FDA) issued another warning for patients: these devices could be vulnerable to hacking. In a recent warning letter, the FDA cautioned patients that a software update must be made to protect the device from cybersecurity vulnerabilities.

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Dax F. Garza
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