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Medical Devices Nancy Holston Medical Devices Nancy Holston

Are Medical Devices Studied on “Whites Only?” Do We Know What Works for Which Patients?

For many years, Congress (especially women in Congress) criticized the FDA for not requiring companies applying for approval to include enough women, people of color, and people over 65 in clinical trials. As a result, many drugs and devices were approved on the basis of studies primarily of relatively young, mostly white males.

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Medical Devices, Women's Issues Nancy Holston Medical Devices, Women's Issues Nancy Holston

ParaGard IUD - Birth Control Device MDL Forms in Georgia

Paragard is an IUD (intrauterine device) implanted in the uterus to prevent pregnancy. The device is made by Cooper Surgical and received an FDA New Drug application approval in 1984. Among the three IUDs on the market - Mirena, Skyla and Liletta - Paragard is the only one that uses copper, not a hormone. Unfortunately, there have been thousands of reports of problems in women implanted with Paragard, including at least 15 deaths.

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