Intuitive Surgical’s da Vinci Robot System the Focus of Two Class II Recalls
Two actions recently involving more than 110,000 components of Intuitive Surgical’s da Vinci surgical robot system have been classified as Class II recalls by the U.S. Food and Drug Administration (FDA). The FDA’s Class II designation is reserved for situations in which “use of or exposure to a violative product may cause temporary or medically [...]
Fracking Fluids May Disrupt Hormones, Raise Infertility Risk
Researchers just reported that the fluids used in hydraulic fracturing—fracking—contain chemicals that may disrupt the functioning of human hormones and lead to a greater chance of infertility, cancer, and other health problems. Fracking is a drilling technique that uses large amounts of highly pressurized water and chemicals to fracture shale and release natural gas and [...]
Stryker Reaches First Settlements in Rejuvenate Hip Lawsuits
Medical device maker, Stryker, has settled four of the lawsuits it faces over its recalled Rejuvenate metal-on-metal hip implants. Ten cases are involved in the first phase of mediation under Judge Brian Martinotti of the New Jersey Superior Court for Bergen County, MassDevice.com reports. Four cases have been settled for undisclosed terms, three more are [...]
FDA Alert: Risk of Long-lasting Erections with ADHD Drugs
On Tuesday, the U.S. Food and Drug Administration (FDA) issued a warning that methylphenidate products, a type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may cause prolonged and sometimes painful erections known as priapism. Based on a recent review of methylphenidate products, the FDA has updated drug labels and patient Medication [...]
Woman Sues over Complications, Need for Revison Surgery from Failed Biomet Hip Implant
A lawsuit filed on behalf of a 60-year-old South Carolina woman alleges that the Biomet M2a Magnum metal-on-metal hip replacement system, which she had implanted in both hips, is defective, and caused pain and other injuries, requiring revision surgery to remove and replace the left hip device.
FDA Questions Safety of Antibacterial Soap Ingredients
Addressing mounting concerns about possible harm from the chemicals in antibacterial soaps and toothpaste, the U.S. Food and Drug Administration (FDA) said on Monday that it was requiring manufacturers to demonstrate that the substances are safe or they must take them out of the products. Public health experts have long urged the FDA to regulate [...]
Vitamin B12 Deficiency, Neurological Side Effects Associated with Antacid Use
Emerging research reveals that some antacids increase risks for vitamin B deficiency and related neurological side effects. The research was published on December 11, 2013 in JAMA: Journal of the American Medical Association. According to the study, long-term use of proton pump inhibitors (PPIs) and histamine 2 receptor antagonists (H2RAs) were tied to vitamin B12 [...]
Combination Treatment with Fluoroquinolones and Corticosteroids Increases Risk of Adverse Effects
Recent research reveals a link between increased risks of tendon injury in patients taking a fluoroquinolone antibiotic, such as levaquin, in combination with a corticosteroid. The researchers sought to “…determine the strength of the association between fluoroquinolone use and tendinopathy, and to identify risk factors for this complication,” AdverseEvents.com reports. The study appears in the [...]
Risperdal Plaintiffs Seek Release of Johnson & Johnson Study Data
Plaintiffs in product liability lawsuits against Johnson & Johnson’s Janssen Pharmaceuticals division involving the antipsychotic drug Risperdal, last week asked a Pennsylvania judge to release clinical study data that they say should not remain under seal, as the data has been since 2011. Johnson & Johnson’s Janssen Pharmaceuticals division faces nearly 275 product liability suits [...]
FDA Warns That Nipple Aspirate Test Not an Alternative to Mammogram
The U.S. Food and Drug Administration (FDA) this week issued a Safety Communication to alert the public and health care providers that a nipple aspirate test is not an acceptable alternative to mammography or other breast imaging tests or breast biopsy, and should not be used by itself to screen for or diagnose breast cancer. [...]
