A patient relies solely on the medical team when a necessary procedure is preformed whether it be a pacemaker or tissue transplant. But how safe are these devices? Where did the tissue come from? Americas Watchdog is concerned and watching out for you.

For the third time in less than a year, Boston Scientific is having more problems with implantable defibrillators. This time, the firm has advised doctors that brands Contak Renewal 3, Contak Renewal 4 and Vitality HE ICDs might be defective, said The Wall Street Journal.

Alcon Research LTD, doing business as (DBA) Alcon Laboratories, Inc. at 15800 Alton Parkway, Irvine, California, has issued a Class I recall of its Constellation Vision System, said the U.S. Food and Drug Administration (FDA). Class 1 recalls, the most serious type, mean there is a reasonable probability that use of these products will cause severe adverse health consequences or death.

The Alcon Constellation Vision System is an ophthalmic microsurgical system used by eye surgeons to perform various kinds of eye surgery.

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Today, the U.S. Food and Drug Administration directed Baxter Healthcare Corp. how to specifically carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP). They must also give customers a refund, replacement pump, or lease termination.

Baxter is responsible for recalling as many as 200,000 CVIP currently used in the United States. Under the FDA’s mandate, Baxter will provide a transition guide to assist affected customers that will include a list of FDA-cleared or approved pump alternatives, suggestions to help minimize disruption and patient risk during the transition period, and detailed information on the refund, replacement, and lease termination programs.

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Dentist Jason M. Yamada has filed a class action complaint against Nobel Biocare Holding AG, alleging one of its dental implants causes gum problems, bone loss and other injuries. And dentists are stuck paying for patient damage and repairs.

The California dentist filed the motion Wednesday in the U.S. District Court for the Central District of California on behalf of thousands of colleagues seeking reparation for alleged defects in the dental implant product.

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Kickbacks are costly as Minnesota based St. Jude Medical Inc. discovered. The once highly regarded firm has agreed to pay $3.7 million in an agreement with the U.S. Justice Department to settle allegations it paid Ohio and Kentucky hospitals to procure sales of heart devices. The charges resulted from a former sales manager’s whistleblower lawsuit filed against St. Jude in 2006.

According to a Justice Department press release, the kickbacks included alleged “retroactive” rebates paid contingent on a hospital’s prior purchases of heart-device equipment and rebates the company paid for the same items sold by its competitors to induce future purchases of similar implements from St. Jude.

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Minneapolis medical device maker Medtronic Inc. has admitted shelling out over $15.7 million in royalties and consulting fees to U. S. doctors in the first quarter of this year, said the Wall Street Journal. The revelation came prior to a new federal law that will mandate such disclosure details by 2013. The announcement came at a time when Congress and federal prosecutors are delving into cozy affiliations among physicians and drug and device firms, wrote the Journal.

Orthopedic specialists and surgeons reaped the most financial benefit–$14.2 million. Royalty payments of $13.9 covered physicians’ surgical inventions, $512,000 went to cardiac and vascular specialists, $495,000 was pocketed by heart-rhythm doctors, and neurosurgeons and neurologists collected $$473,000, added the Journal. Another 227 physicians and doctor groups garnered royalty or consulting payments of more than $5,000. Lesser payments to foreign physicians and those conducting clinical trials were not reported.

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The U.S. Food and Drug Administration’s (FDA) Transparency Task Force today released 21 draft proposals on public disclosure policies aimed at helping consumers, stakeholders, and others understand how the agency operates and makes decisions. The Transparency Task Force will review the comments and decide which proposals to recommend for implementation.

The FDA formed the Task Force in June 2009 in response to the Obama Administration’s commitment to achieve “an unprecedented level of openness in Government.”

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The U.S. Food & Drug Administration (FDA) has sent St. Jude Medical Inc. a warning letter, which is posted on the agency’s web site. The content alleges that St. Jude promoted the Epicor surgical ablation device to treat atrial fibrillation, an unapproved use by the agency.

Surgical ablation devices such as the Epicor system are approved for “ablation,” or the burning of tissue, to seal a wound to stop bleeding. While doctors are permitted to use medical devices any way they want, manufacturers are legally barred from marketing or promoting such uses. The FDA has given St. Jude permission to investigate the Epicor system’s use in treating atrial fibrillation, but presently does not allow the medical facility to market it for this use.

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The U.S. Food & Drug Administration (FDA) has announced their most serious Class I recall for GE Healthcare’s Aisys and Avance Anesthesia Systems. A Class I recall is implemented if there is reasonable probability that use of a device will cause severe adverse health consequences or death.

The Aisys and Avance Anesthesia Systems, intended for volume or pressure control ventilation, are prescription devices used in healthcare settings under the supervision of a physician. They provide general inhalation anesthesia and ventilation support to a variety of patients.

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