Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records

Inadequate Reporting: The article points out a lack of comprehensive and consistent reporting of medical device malfunctions, making it challenging to identify and address issues promptly.

Patient Harm: It underscores instances where medical device malfunctions have resulted in harm to patients, highlighting the real-world consequences of these problems.

FDA Oversight: The article criticizes the FDA's oversight, suggesting that it has not been robust enough to prevent these issues effectively.

Data Gaps: There are significant data gaps in tracking medical device performance and safety, making it difficult to assess risks and benefits.

Calls for Improvement: It emphasizes the need for improved regulation, transparency, and data collection within the medical device industry to better protect patient safety.