Articles Posted in Medical Devices

The Mirena IUD (Intra-Uterine Device) was given FDA approval as a long acting form of birth control and for treatment of heavy menstrual bleeding. It is a T-shaped device that is inserted into a woman’s uterus in order to prevent fertilization. In addition, the device also releases a synthetic form of progesterone known as levonorgestrel, to stop a woman from producing and releasing an egg.
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Retrievable inferior vena cava (IVC) filters are a type of vascular filter that is implanted in the heart in order to help prevent life threatening pulmonary embolisms and can be removed when they are no longer necessary. According to the FDA, approximately 200,000 of these devices are implanted into patients each year – many of which – were either most likely not medically necessary in the first place or should have been removed when they were no longer necessary.
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Stryker has issued a voluntary recall on its Rejuvenate Modular Hip. While the Stryker Rejuvenate can be used as a component of either metal or ceramic hip implants, the metal on metal modular component can potentially cause fretting and corrosion that may result in pain, swelling, tissue damage and metallosis. The Rejuvenate System can also lead to premature failure due to aseptic loosening and possibly pseudotumor formation.
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The Biomet Magnum hip replacement device is a metal on metal system which includes chromium and cobalt in its composition. The friction caused by the metal components rubbing against one another can result is metal fragment being released into the surrounding tissue and blood stream. These metal fragments can lead to tissue damage including inflammation, bone loss, necrosis, and blood poisoning known as metallosis. Other possible side effects from hip implants include loosening, dislocation and possible fracture.
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The AP (6/29, Perrone) reports, “Government health experts said Thursday there are few reasons to continue using metal-on-metal hip implants, amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles.” According to the AP, “the Food and Drug Administration asked its 18-member panel to recommend guidelines for monitoring more than a half-million US patients with metal hip replacements.” Although the agency “has not raised the possibility of removing the devices from the market, most panelists said there were few, if any, cases where they would recommend implanting the devices.”

We will soon know how juries feel about the conduct of the manufacturers of transvaginal mesh devices. The first case is set to go forward this November 2012 against Johnson & Johnson – Ethicon division over claims that its Gynecare Prolift injured women. Superior Court Judge Carol Higbee will be presiding over this trial.
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Knee and Hip Implants: New Not Always Better Than Old?

New technology is supposed to be better than the old, but what happens if the new proves not only to be more expensive, but can show no real advancement prior to the older versions? Technology is an advancing arena but, with artificial hip and knee replacements, it is proving to not be the case.
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The ability to move around without pain is something most of us don’t think about, so when patients undergo knee replacement surgery they believe their pain will go away. However, if the patients are still experience pain it could be the result of a fracture, if the replacement was a Smith and Nephew-Journey knee.
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