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FDA: J&J Marketed Vaginal Mesh Implant Without Approval

The Gynecare Prolift was introduced in March 2005 by J&J, however the U.S. FDA did not learn about the Prolift until 2007 when J&J was seeking approval for a related product.  There are currently more than 550 lawsuits against J&J alleging injuries caused by vaginal mesh implants.

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Consumer Reports Incensed over Bad Medical Devices

The publication Consumer Reports has been long known for it’s reviews of products including automibiles and home appliances, but has now taken on medical devices.  Cosnumer Reports President, Jim Guest wrote an email to 1 Million Americans earlier this year stating, “The implant that fixed your knee or your heart may acutally be a ticking time bomb that could disable …

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Higher Failure Rates Found in Larger Metal-on-Metal Hip Implants.

A British review of larger diameter metal on metal hip implants found, “unequivocal evidence that metal-on-metal stemmed prostheses are associated with higher failure rates than other types, and that the use of large head sizes, and use of these prostheses in younger women, is associated with a particularly high rate of early revision surgery.”

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Important Reminder from FDA: Defective AEDs Recalled

The Food and Drug Administration is reminding owners of automatic external defibrillators (AEDs) to check whether their devices are subject to a Jaunary recall.  Certain AEDs contain a defective component that could cause the AED to not delvier defibrillation.  Because of the seriousness of this issue the agency has classified this recall as class I, the most serious category of …

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Pfizer Recalls 1M Packets of Birth Control Pills

As the result of a packaging error, Pfizer has recalled 1M packets of birth control pills.  A statement issued by Pfizer indicated that, “As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception and at risk for unintended pregnancy.  The recall involves 14 lots of Lo/Ovral-28 …

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Diabetes drugs linked to pancreatic cancer- Older drug the best

Newer isn’t always better.  A new study links the drug metformin, prescribed for diabetes, to fewer cases of pancreatic cancer, at least in women, but finds other diabetes medications are associated with a higher risk of the disease. According to Dr. Peter Butler, a diabetes researcher at UCLA  ”the oldest drug we have for diabetes, metformin, is undoubtedly the best …

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Accidental Child Poisoning: A growing Epidemic

  The Journal of Pediatrics recently published a study showing thtat over the past decade increasing numbers of young children have been hospitalized or injured due to accidental poisoning from prescription and over-the-counter (OTC) medications.  The majority of the cases involved unintentional self-ingestion for example where a child finds pills from an open container prescrived to a bparent or family …

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CAUTION: FDA Warns of Opioid Mix-Up

The FDA has issued a warning that Percocet and eight other opiod products packaged by Novartis may have been mixed up. Patients should be wary of any pills that are different in size, shape, color or markings from their standard medication. A full list of the effected medications can be viewed on the FDA website at: http://www.fda.gov/Drugs/DrugSafety/ucm286226.htm

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Surgical Mesh Makers ordered by FDA to Study Risks

The Food and Drug Administration has ordered medical device manufacturers to study safety complications with surgical mesh used in women’s pelvic surgeries. In April an FDA report found that women who have the surgical mesh implanted are at greater risk of pain , bleeding and infection than women who have traditional surgery with stitches. For more information visit the FDA …

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BREAKING NEWS- YAZ Settlement Discussions to Begin

http://www.youtube.com/watch?v=g1HRXYkHE2c&feature=autoplay&list=HL1327525343&lf=mh_lolz&playnext=1 January 5, 2012.  The first Yaz trial which was set to begin next week has been postponed in an effort to reach a settlement of the claims. Judge David Herndon has appointed a mediator to work with the parties to reach a settlement. There have been more than 10,000 suites filed in the Multidistrict Litigation.

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