Tagged Articles

hospitalizations 45 articles

Accidental exposure to fentanyl skin patch can be deadly to kids

The Food and Drug Administration (FDA) is warning patients, caregivers and health care providers that accidental exposure to the skin patch containing the powerful painkiller fentanyl can be deadly, especially to young children, and that extra caution should be exercised for storing and disposing of the patches. The agency has received reports of young children who have died or become seriously ill from accidentally coming in contact with these skin patches. “These types of events are tragic; you never want this to happen. We are looking for ways that we can help prevent this from happening in the future,” says ... Read More

Injection therapy for incontinence may be safer than transvaginal mesh

A new procedure for treating urinary incontinence in women has been approved for use in the United Kingdom. The innovative new injection therapy offers another alternative to women who are seeking treatment for this common condition. Urinary incontinence is a bladder weakness that can be caused by age, childbirth, or weight gain. Special exercises are the least invasive option, but one of the more common procedures is the vaginal insertion of surgical mesh, also known as a bladder sling. The product is far from flawless. In some women, the mesh has eroded into the vaginal wall, causing excruciating pain and ... Read More

FDA wants more data on safety of transvaginal mesh

Manufacturers of surgical mesh used to repair pelvic floor disorders including pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are being asked by the Food and Drug Administration (FDA) to conduct new studies on the safety of the products. The review is in response to mounting complaints associated with the transvaginal use of the mesh. Inserted through the vagina to shore up organs that have slumped from childbirth or obesity, the mesh offers an attractive non-invasive alternative to surgical repair. However, complaints show that the mesh often over time begins to erode into the vaginal wall. This causes pain, ... Read More

Transvaginal mesh makers ordered to conduct safety studies

The Food and Drug Administration (FDA) has ordered manufacturers of surgical mesh used to treat pelvic floor disorders to conduct three years of trials to determine just how dangerous their devices are and whether they provide any benefit over older methods of treatment. The order comes just months after the FDA began a safety review on the mesh after discovering a five-fold jump in deaths, injuries and malfunctions associated with the devices. Transvaginal mesh is used to repair conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh is implanted through the vagina and is used ... Read More

Texas woman files lawsuit against transvaginal mesh manufacturers

A lawsuit has been filed against Johnson & Johnson and Ethicon Inc., by a Texas woman who claims the manufacturers knew their transvaginal mesh device used to treat pelvic floor disorders was dangerous and could cause severe harm. The lawsuit was filed in the Eastern District of Texas Beaumont Division on Dec. 8, 2011. The lawsuit alleges that the medical device manufacturers negligently designed and marketed the Gynecare Profilt and TVT, which are surgical mesh devices used to treat disorders such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The devices recently have come under review by a ... Read More

Drug, medical device companies should share data on product safety

Clinical trials on pharmaceutical drugs and medical devices provide important data regarding the safety of these products. This information is usually published in medical journals, which provide policy makers and doctors with valuable information. However, only a small number of data from clinical trials ever gets published, a problem that distorts scientific record and puts patients in danger, warns the British Medical Journal. The revered medical journal recently released several papers that address the problem of unpublished data from clinical studies, including Yale University research that found fewer than half of the 635 clinical trials funded by the National Institutes ... Read More

Senator calls for FDA review of OTC energy inhaler

A New York senator is asking the Food and Drug Administration (FDA) to review the safety and legality of the AeroShot Pure Energy caffeine inhaler, a lipstick-sized canister of caffeine powder and B vitamins, which will hit store shelves in New York and Boston next month. The energy inhaler will be sold over-the-counter with no age restrictions, and is being marketed for its convenience and zero calories. Democrat Charles Schumer warns that the product could be considered a “club drug” and be particularly hazardous to teenagers. If taken with alcohol, the product could have the effects similar to caffeinated alcohol ... Read More

Four drugs send most elderly patients to the hospital

Nearly 100,000 hospitalizations every year are related to adverse drug reactions and unintentional overdoses, and nearly half of those hospitalized are adults 80 years of age or older, according to a study published this month in the New England Journal of Medicine. Researchers say the major culprits are four drugs – warfarin, oral antiplatelet medications such as aspirin, insulins, and oral hypoglycemic agents used to treat diabetes. The study also pointed out that better management of antithrombotic and anti-diabetic drugs could reduce the number of emergency admissions by thousands. The study identified a small group of blood thinners, such as ... Read More

Researchers to test bladder sling for men

Researchers are trying to determine whether inserting a surgical mesh sling in men undergoing radical prostate surgery for prostate cancer will help with incontinence issues. The biodegradable “sling” would be inserted during robot-assisted prostate cancer surgery and support the neck of the bladder and uretha after removal of the prostate gland. The study, conducted by researchers at Indiana University School of Medicine, will assess urinary problems in patients following a complete removal of the prostate due to cancer. Half of the men in the study will receive one of the slings, while the others will receive current standard care without ... Read More

Lawyers investigating claims of injuries from transvaginal mesh

Attorneys for Beasley Allen Law Firm are currently investigating cases of injury caused by surgical mesh used to repair pelvic floor disorders. Transvaginal mesh is a device used to repair conditions such as stress urinary incontinence and pelvic organ prolapse. The mesh has come under the spotlight recently after an alarming number of complaints to the Food and Drug Administration (FDA) adverse event reporting program, MedWatch. Transvaginal mesh is made of porous absorbable or non-absorbable synthetic material or absorbable biologic material. In the repair of pelvic floor disorders, the mesh is permanently implanted to reinforce the weakened vaginal wall or ... Read More