The Food and Drug Administration secretly monitored the personal e-mail of a group of its own scientists and doctors. Before, they had warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients, government documents show. Six of the scientists and doctors filed a lawsuit against the FDA in U.S. District [...]
Tag Archives | Medical Devices
A Side Effect Database
Are you curious as to many other people have had the same side effects as you have to your prescriptions? What about how your drug compares with similar drugs? Of course the U.S. Food and Drug Administration has millions of reports, ranging from fatigue to fatal heart attacks, on thousands of prescription drugs dating back to [...]
Metal-on-Metal Hip Implant Finds No Increased Cancer Risk?
We have written countless articles discussing the dangers of metal-on-metal implants, yet a new study is downplaying the potential dangerous effects, such as the risk of cancer. The recent study was published in the British Medical Journal which analyzed cancer rates among patients with metal-on-metal implants versus patients with other types of implants as well [...]
FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump
FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without [...]
For F.D.A., a Major Backlog Overseas
The Food and Drug Administration is so understaffed that, at its current pace, the agency would need at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant, according to government investigators. [...]
Medical Device Disaster: Medtronic Recalls Defibrillators
Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic’s action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are [...]
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Latest Drug Injury News
Medical Mattresses Pose Risk Of Infection And Contamination
The FDA warns that medical mattresses may not be as clean as once perceived. Routine checks on mattresses are advised as any rips, tears, or excessive wear alter the efficacy. The medical mattresses as well as the covers have an expected life depending on the manufacturer, which should not go unnoticed.
On Third Of Children Medications Are Only Tested On Adults Leading To Improper UseOne third of children medications are not tested on children, but rather adults. Thus, these drugs are approved for adult use. Companies base the dosages off the adult studies, increasing the risk for improper use.
Epilepsy Drug During Pregnancy Linked To AutismExpectant mothers who take the popular anti-epileptic drug valproate during pregnancy should be aware that there is an increased risk for their child developing autism compared with children of women who did not take the epilepsy drug, according to a recently published Danish study. Valproate is a drug used for the treatment of epilepsy and other [...]
Cough Syrup Responsible For Over 36 DeathsPakistani authorities are investigating allegations that cough syrup has killed at least three dozen people, a government official has announced, making this the second time in recent months that medicine is suspected of causing multiple deaths. The deaths from the cough syrup occurred in the eastern city of Gujranwala and nearby villages, said local official [...]
Merck Settles Vioxx Class-Action LawsuitIn almost a decade old battle, Merck & Co. Inc. has agreed to settle a class action lawsuit filed on behalf of Missouri consumers over its prescription pain reliever Vioxx in a deal that could cost the drugmaker up to $220 million, lawyers for the consumers said. According to CNBC, the agreement announced on November [...]
Latest Medical Device Injury News
Metal-on-Metal Hip Implants Cause Soft Tissue Damage Says FDA
Hip joint deterioration can lead to pain, stiffness or difficulty walking. When these symptoms do not respond to conservative treatment, such as physical therapy, patients may be advised to undergo total hip replacement or hip resurfacing. As part of this treatment, they may receive a “metal-on-metal” hip implant in which the “ball and socket” of [...]
Ethicon Recalls Surgical StaplerThe FDA has announced a voluntary global recall of more than 157,000 Ethicon surgical staplers, due to problems with incomplete firing strokes that may cause faulty staple formation, potentially resulting in painful and severe internal complications for the patient. An Ethicon surgical stapler recall was first announced in August, after reports surfaced where surgeons experienced [...]
Another Device Maker Investigated By DOJEarlier this month, cardiovascular device maker Abiomed announced that the US Attorney’s Office was investigating the company’s marketing and labeling of the Impella 2.5 circulatory support device. According to Forbes, the announcement confirmed rumors that had been circulating for at least two weeks, though in the press release the company said it had just been [...]
A Medical Device Horror StoryCNNMoney describes the chilling details of the bone cement horror stories surrounding the medical device company Synthes. In 2009 the U.S. attorney in Philadelphia accused the medical device manufacturer of running illegal clinical trials — essentially, experimenting on humans. Between 2002 and 2004, Synthes tested a product called Norian XR, a cement that has a [...]
Non-FDA Approved Stryker Surgical Device Recall And AlertStryker Neptune Waste Management System is the subject of a recent FDA recall and safety alert. The non-FDA approved device can cause bleeding as well as soft tissue, muscle and vital organ damage. The Stryker Neptune Waste Management System is used during surgical procedures to collect fluid waste from the patient. The Neptune 2 Ultra [...]
