Tagged Articles

surgery 77 articles

Spokeswoman for 3M Says Lawsuits Against Bair Hugger are Due to “Bad Science”

3M, the maker of the Bair Hugger device used during surgeries to keep patients’ temperatures regulated, claims that the lawsuits against it regarding infection linked to the single-use blankets are based on “bad science.” In an article by Star Tribune, 3M spokeswoman Donna Fleming Runyon said, “3M will vigorously defend the product and the science against these unwarranted lawsuits.” She also added, “We think it’s unfortunate that the plaintiffs’ attorneys are using bad science to blame their clients’ infections on a device that has helped so many people.” The Bair Hugger forced-air warming blanket is used in four out of five hospitals ... Read More

Lawsuit against Bayer claims Mirena IUD migrated to rectum

Jennifer Martin was shocked when she learned in September 2012 that she was pregnant. Two months earlier she had gotten a Mirena IUD contraceptive device. An ultrasound confirmed the pregnancy but did not offer any clues as to where the IUD had gone. It was a perplexing mystery, and one that had to be resolved. Shortly after, Jennifer had a miscarriage. A month later, her doctor performed surgery to conduct an extensive search for the IUD among her internal organs, including the liver, spleen and stomach. The intrauterine device was eventually found in her rectum. Bayer Healthcare faces more than ... Read More

Mirena IUD linked to increased breast cancer risk in premenopausal women

Premenopausal women who use a hormone-releasing intrauterine device, such as the Mirena IUD, are at greater risk of developing breast cancer, according to a study recently published in the journal Obstetrics & Gynecology. There are three IUDs marketed in the United States – the ParaGard, Mirena and Skyla. Only Mirena and Skyla, which are both made by Bayer Healthcare, contain a small amount of the levonorgestrel, a synthetic form of the hormone progestin. IUDs are used to prevent pregnancy, but levonorgestrel-releasing IUDs can reduce heavy bleeding and are often given to women to help treat heavy periods, a condition known ... Read More

Bayer faces lawsuits over injuries caused by Mirena IUD

The minute Sarah was implanted with a Mirena IUD contraceptive device, she felt excruciating pain. She tried to tough it out, but it became so severe she went to the emergency room. There, doctors discovered that her intrauterine device had perforated her uterus and migrated into her abdomen. She needed surgery to have it removed. “They told me that it needed to be removed as soon as possible,” Sarah told ABC 15. “It was horrible. I would never recommend it to anyone.” Sarah is not the only woman to experience complications with the Mirena IUD. Since the device was approved ... Read More

Hospira recalls injectable anesthetic Lidocaine due to particles floating in solution

Hospira, Inc., is recalling one lot of its injectable drug Lidocaine because of a confirmed report of discolored solution with visible particles floating in it as well as particulate embedded in the molded glass container. Hospira has identified the particulate as iron oxide, and said it is due to a supplier’s glass defect. Hospira is working with its supplier on implementing corrective and preventative actions. To date, no adverse events have been reported related to this recall, however if patients are injected with the particles – depending on the particle size and number – it could block administration of the ... Read More

Implantable birth control microchip to enter pre-clinical trials next year

A new implantable birth control device containing the hormone levonorgestral that lasts 16 years and can be turned off and on with a wireless remote is currently in development and will enter pre-clinical testing next year. The chip is designed to be implanted under the skin at the buttocks, upper arm, or abdomen, and if tests prove it to be safe and effective, the device could be on the market as early as 2018. The concept of a birth control chip originated two years ago when Bill Gates and his colleagues visited Massachusetts Institute of Technology (MIT) and asked technicians ... Read More

FDA approves Bayer Inserter for Skyla, Mirena IUDs

The Food and Drug Administration (FDA) has approved a new inserter device by Bayer HealthCare Pharmaceuticals designed to aid in the insertion of the company’s own intrauterine devices, the Mirena IUD and Skyla IUD. Both the Mirena and Skyla IUDs are flexible, T-shaped devices that are inserted into the cervix where they release the hormone levonorgestrel. Skyla prevents pregnancy for up to thee years, while Mirena is considered effective for up to five years. Mirena is also indicated to treat heavy bleeding in women who choose to use an IUD as their method of contraception. Mirena is designed for women ... Read More

Type 2 diabetes drug adds new warning for serious injection site reactions

New information has been added to the safety label of the injectable type 2 diabetes drug Bydureon to include a new warning that some people using the medication have experienced serious injection-site reactions, some of which have required surgical intervention. The new Injection-Site Reaction information was added to both the Warnings & Precautions and the Adverse Events sections of the medication, and new information was added to the patient counseling information and medication guide. Injection-site reactions reported include abscess, cellutitis and necrosis, with or without bumps, or nodules. Patients are advised to contact their health care provider immediately if they experience ... Read More

Autism treatment exposes children to serious side effects

Risperidone was the first drug approved to treat children with autism and can help reduce irritability, but the side effects are alarming, according to an informal analysis of the drug. Risperidone, also known by the brand name Risperdal, is an antipsychotic medication approved to treat adults and children with bipolar disorder, schizophrenia, and irritability with autism. It is also prescribed off-label for various behavior problems including attention-deficit hyperactivity disorder (ADHD), attention-deficit disorder (ADD), anxiety and depression. Risperidone has shown to be an effective treatment for the explosive and aggressive behavior expressed by some people with autism, taming tantrums in a ... Read More

FDA calls for stricter safety guidelines, pre-market approval for transvaginal mesh for incontinence

Stricter safety requirements may be required for the manufacturing of transvaginal mesh under a Food and Drug Administration (FDA) proposal. The surgical mesh used to treat common pelvic floor disorders in women should be reclassified as “high risk,” the agency said in response to mounting reports of complications from the device. Transvaginal mesh, also known as vaginal mesh or a bladder sling, is used to treat pelvic organ prolapse and stress urinary incontinence. It is inserted through the vagina to hold up organs that have dropped causing symptoms such as discomfort and incontinence. The mesh was widely used in women ... Read More