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FDA faulted for failure to track safety issues with drugs already on market

“Safety concerns often arise only after the drugs go on the market, when companies or doctors tell the FDA about cases of patients who have fallen ill or died from their medications.”

Categories: Drugs, Hip and Knee Replacement
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The 21st Century Cures Act — Will It Take Us Back in Time?

Embedded in the language of the 21st Century Cures Act are some good ideas that could streamline the development and evaluation of new drugs and devices; its call for increased NIH funding may prove to be its most useful component. But political forces have also introduced other provisions that could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit.

Categories: Drugs, Hip and Knee Replacement, Hospital Infections/ Superbugs
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Opinion: Don’t Weaken the F.D.A.’s Drug Approval Process

“The 21st Century Cures Act, which would lower standards for the approval of many medical products and potentially place patients at unnecessary risk.”

Categories: Hip and Knee Replacement, Hospital Infections/ Superbugs
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Long-Term Data on Complications Adds to Criticism of Contraceptive Implant

Essure is not a sure bet for women who have suffered the consequences of the device failing, resulting in everything from pain, bleeding to pregnancy.

Categories: Hip and Knee Replacement, Medical Errors
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5 Reasons Why Duodenoscope Problems Matter

Duodenoscopes have contributed to deadly CRE infection outbreaks across the country. Learn how to protect yourself.

Categories: Hip and Knee Replacement, Medical Errors
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3 Questions To Ask Your Doctor About Your Medications

Learn the Risks and Benefits of Any Drug You Take Taking a new medication is a big deal. When a doctor recommends a new prescription, you should walk away knowing why it was prescribed and how you should monitor your symptoms after taking it. The more informed you are as a patient, the easier it will Continue Reading

Categories: Doctor Accountability, Drugs, Medical Errors
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Consumers Union Comments to FDA on Reclassification of Surgical Mesh

Consumers Union strongly supports the FDA’s proposed order to change the classification for surgical mesh used to repair transvaginal Pelvic Organ Prolapse (POP) from Class II to Class III. This change will require any future mesh product for POP to provide much needed clinical evidence demonstrating it is a safe and effective device before it is marketed for use in patients.

Categories: Hip and Knee Replacement
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Consumers Union comments to FDA regarding direct to consumer TV ads

Consumers Union’s Safe Patient Project submitted comments to FDA about a proposed rule to study limiting the list of drug side effects in a TV drug ad. We have concerns about the possibility of limiting major drug side effects in drug ads, and believe the FDA proposed study has design flaws.

Categories: Drugs
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FDA Warns Against Hysterectomy Technique That May Spread Cancer

A Boston couple behind a campaign to stop doctors from performing a risky surgical procedure is applauding a new U.S. Food and Drug Administration warning against doctors performing the procedure called laparoscopic power morcellation. The FDA warned doctors that this procedure to uterus or uterine fibroids poses a risk of spreading unsuspected cancerous tissue beyond the uterus.

Categories: Hip and Knee Replacement, Medical Errors
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The Device Makers’ Shortcut

The FDA has been criticized for approving medical devices through the 510K (fast track) approval requiring no clinical trials. But there’s another way-read on.

Categories: Hip and Knee Replacement
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