J&J Marketed Transvaginal Mesh Product For 2 Years Without FDA Approval

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.

One 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.

Expectant 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 [...]

Pakistani 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 [...]

In 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 [...]

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 [...]

The 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 [...]

Earlier 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 [...]

CNNMoney 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 [...]

Stryker 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 [...]