According to the FDA, there have been 26 incidents of accidental fentanyl exposure since 1997 resulting in ten deaths and twelve cases requiring hospitalization. Most of the cases invovled children. The FDA issued a consumer advisory Thursday reminding parents, caregivers and medical personnel of the deadly consequences posed to children from accidental contact with or…
DetailsOver the past several months we have passed along some very discouraging information about Metal-on-Metal hip prostheses. We are happy to have something positive to report: According to a published report in HealthDay News on April 3, 2012, “People with metal-on-metal hip replacements do not have an increased risk of cancer during the first seven…
DetailsA lawsuit filed by a physician who worked under contract for Takeda, the maunufacturer of Actos, a diabetes medication, alleges that the pharmaceutical company failed to accurately report cases of bladder cancer. The lawsuit was filed by Dr. Helen Ge who also asserts in the lawsuit that Takeda failed to report all cases of heart…
DetailsZofran has been connected to a wide range of birth defects. Prescription drugs are often at the center of legal action. In many of these cases, it is uncovered that the drugs were not properly evaluated before they were marketed to physicians to prescribe to their patients. In other cases, drugs were prescribed outside of…
DetailsThe U.K.’s Medicines and Healthcare products Regulatory Agency issued a statement urging surgeons to stop using a specific combination of Johnson & Johnson and Stryker metal hip devices due to unacceptably high rates of failure. The combination is Mitch TRH cup/heads and Accolade femoral stems.
The FDA has announced that it will hold an advisory panel on June 27-28 to gather input from scientists, researchers , patients and medical practitioners to help regulators decide whether to impose new testing standards and review requirements before a medical devide is sold in the U. S. This panel is in response to mounting…
DetailsThe 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.
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.”
The publication Consumer Reports has been long known for it’s reviews of products including automobiles and home appliances, but has now taken on medical devices. Consumer 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 actually be a ticking…
DetailsAs 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…
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