MedTech Dive, November 5, 2019. The original clinical data supporting FDA’s approval of Essure was insufficient, as seen in Bayer’s small sample size in the Essure postmarket study.
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FDA Keeps Brand-Name Drugs on a Fast Path to Market ― Despite Manufacturing Concerns
Kaiser Health News and Daily Beast, November 3, 2019. More caution is warranted as the FDA keeps brand-name drugs on the fast path to the market, despite concerns about manufacturing and pre-market inspections.
Read More »When Recalls Fail: Many harmful products remain in homes and stores. Why that happens, what needs to change, and how to protect yourself.
Consumer Reports, October 31, 2019. Whether it be contaminated food, deadly infant sleepers, breast implants, or other unsafe products, recalls are not protecting us as well as they should be.
Read More »FDA calls for new warnings for breast implants
The Washington Post, October 23, 2019. Due to problems with breast implants, FDA calls for new warnings associated with the implants as well as providing more information about the devices.
Read More »Women Should Be Warned of Breast Implant Hazards, F.D.A. Says
NY Times, October 23, 2019. In light of breast implant hazards, FDA proposes that surgeons discuss the risks with patients and that manufacturers print bold warnings on the device packaging.
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