Posts Tagged 'FDA'

As FDA Rails Against ‘Vaginal Rejuvenation’ Doctors Say Not So Fast

The FDA has recently taken aim at several companies it says are marketing devices for uses other than those they were approved to treat. At issue is the use of energy and laser devices – usually used in dermatological and other similar procedures – for a treatment that has become known as “vaginal rejuvenation.” The procedure has been said to be capable of remedying several symptoms like vaginal dryness, pain during sex, and other types of ...

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Federal Essure Lawsuits Headed Back to Philadelphia Court

essure lawsuit goes back to state courtEssure will no longer be marketed in the United States in the near future – or anywhere else in the world for that matter – but that doesn’t mean that the lawsuits surrounding the device are going anywhere. And, in at least one situation, a federal court has ruled that, at least for now, it’s not a federal issue.

Bayer had initially requested the move to the federal bench under the ...

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60 Minutes Airs Damning Evidence Against Boston Scientific in Piece on Mesh Claims

60 Minutes airs damaging report on Boston ScienticWith over 100,000 pelvic and other gynecological mesh cases pending in courts around the country, one question that has been on everyone’s mind is much closer to an answer thanks to some investigative reporting that aired earlier this month on CBS’ 60 Minutes.

The question is a simple, yet far-reaching one: what could possibly have gone so wrong with these devices as to cause this level ...

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Essure Faces New U.S. Restrictions

essure facing new sales restrictions in U.S.The sale and implantation of Essure in the United States is facing a new set of federally-mandated restrictions, and the government has left the enforcement of that mandate to the company that manufactures the device being restricted.

In response to a decline in demand for its female sterilization solution that quite literally spans the globe, Bayer ceased sales of Essure in every market on the planet except the United States late ...

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In the Absence of Safety Warnings, Actemra May Have Killed Hundreds

rheumatoid arthritis drug actemra may be responsible for hundreds of deathsAs horrible as it can be to endure a life with rheumatoid arthritis, the side effects of the drugs most commonly associated with the treatment of the condition are equally, if not more terrible. In an analysis of more than half a million side effect reports from these medications, clear patterns emerged that indicate strong links to heart attacks, strokes, and heart failure.

Actemra was marketed with ...

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FDA Issues Safety Announcement for New Liver Disease Drug

fda issues statement on OcalivaBloomberg reports that the FDA has issued a safety announcement for Intercept’s Ocaliva, a drug designed for a rare liver disease known as primary biliary cholangitis. The announcement comes after at least 19 deaths were attributed to the medication, which was only introduced in May of 2016.

Intercept claims to have explicitly warned doctors of the specificity with which they must prescribe Ocaliva and how it must be taken by ...

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