Was FDA approved Essure based on flawed data?

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Insufficient data may have been used by the Food and Drug Administration to approve Essure for the market. That’s the news from Northwestern University, where researchers have studied OB-GYN devices approved by the FDA over the last 15 years. The results of the study? Essure, among others, was sent to market based on flawed and incomplete data.

The study found that Essure was approved on short-term studies in incomplete post-market follow up. Not enough research was done on the long-term effects of the medical device, nor were there any studies conducted about Essure once it was released on the market. More than 25,000 women have experienced extreme symptoms related to their Essure devices. There are as many as 26 deaths associated with the birth control device.

Earlier this month, Representative Mike Fitzpatrick launched medical device and FDA reform bills. He, along with other lawmakers, seek to reform the way the FDA approves devices like Essure. Supporters of the bill hope the FDA will strengthen their review practices and have increased accountability for dangerous products that slip past them and onto the market.

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