For some women a pelvic transvaginal mesh product has been a god sent. To be able to resume a full active life, without the worry of a leaky bladder, is a true miracle for some women. And, this only became possible with the help of pelvic mesh. The mesh is most commonly used after pelvic [...]
Tag Archives | FDA
Zimmer Hip Replacement Receives New FDA Warning
Zimmer’s hip replacement manufacturing troubles are the focus of a September 19, 2012 FDA warning to the beleaguered company. The FDA cited Zimmer’s Trilogy Acetabular System hip replacement devices manufacturing process and testing at a Ponce, Puerto Rico facility. The FDA warning letter followed FDA inspection of the plant in June. Lack Of Testing Evidently [...]
Top FDA Officials Knew Of Email Spying
We have been keeping you up to date and informed on the situation that is headlining many news reports within the US Food & Drug Administration over claims that the FDA was spying on their employee emails; emails that were apparently planning to out the FDA for approving unsafe medical devices. (MORE: FDA Ordered To [...]
FDA Ordered To Turn Over Documents In Email Spying Case
As you may recall we recently reported the case of the FDA spying on their employee emails, and how one lawmaker is urging law enforcement officials to investigate whether the FDA violated the law in its secret monitoring of staff emails. Now further developments in the case show that the FDA was ordered to turn [...]
GE Healthcare Recalls Ventilators Due To Safety Issue
Isn’t it a scary thought to know that a ventilator, something that keeps a person alive after a surgery or traumatic event by breathing for them, could be recalled? But it’s true, as a new recall has just been announced, and apparently just in the nick of time, as lives are possibly in danger due [...]
US Lawmaker Questioning FDA Over Employee Email Spying
When working for a company that is committing fraud, or participating in any other legal activity, as an employee you are allowed to report your company to the federal government, and you are protected to do so, by various laws such as The Whistleblower Protection Act. And many whistleblowers use different methods in order to [...]
Investigation Reveals Problems In Human Tissue Donation
It’s not likely that you’ve put much thought into the process of storing human donor tissue that are used in surgeries on a daily basis. I don’t believe this is just one of those things that the normal person thinks about. But what does happen to the tissue? How do we know it’s safe for [...]
FDA May Ban BPA from Infant Formula Containers
Ever since 2008, when new research suggested that BPA, Bisphenol A – used in packaging to make plastic harder or protect metal can linings – could be harmful to humans, consumer advocates have been pushing for an all-out federal ban on containers carrying the chemical. So far this push has been successful only in the [...]
Banned Drug Found in Herbal Supplement Ingredients
According to a recent warning letter dated February 6, issued by the U.S. Food and Drug Administration (FDA), a Florida herbal supplement maker has two herbal supplements that they believe have prescription strength medications in them, therefore, they are in violation of FDA guidelines. The letter states, after an inspection into the distribution firm “FDA [...]
FDA Ideas to Get Drugs to Patients Faster
FDA Commissioner Margaret Hamburg and the agency’s director of the Center for Drug Evaluation and Research, Janet Woodcock, are trying to think outside the box in order to get drugs into patients’ hands faster. They are debating two ideas and weighing whether or not to allow more medicines to be available to consumers over the [...]
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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 [...]
