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serious injury 98 articles

Small, high powered magnets causing serious injury, death when swallowed

High powered magnets and magnet components marketed as desk toys and sold as stress relievers for adults who use the magnets to create patterns and build shapes can cause serious injury and even death to children from toddlers to teens, according to a safety announcement from the Consumer Product Safety Commission (CSPC). The risk scenario differs by age group but the results are the same. When two or more magnets are swallowed or inhaled, they can attract one another internally, resulting in serious injuries, such as small holes in the stomach and intestines, intestinal blockage, blood poisoning and even death. ... 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

Woman tells story of complications from transvaginal mesh

“It feels like the inside of my vaginal wall is on fire,” Linda Gross, 46, told ABC News. “I wouldn’t wish this on anyone.” Gross is just one of thousands of women who have experienced serious complications following routine surgery to correct pelvic organ prolapse (POP), a condition in which the organs in the pelvis drop due to childbirth, age or obesity. As part of her surgery, surgical mesh was implanted into her vagina to shore up the organs. Instead of relieving her symptoms of bloating and constipation, it appears the mesh eroded into her vaginal wall and left her ... Read More

FDA launches new training program for medical device reviewers

The Food and Drug Administration (FDA) has implemented two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of the individuals tasked with reviewing pre-marketing applications at the agency’s Center for Devices and Radiological Health (CDRH). This program is just one of the 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations announced earlier this year to increase the predictability and transparency of regulatory pathways and to strengthen the 510(k) process, an expedited approval process granted to moderate-risk medical devices determined to be “sufficiently similar” ... Read More

IOM recommends overhaul of FDA’s expedited medical device approval process

Moderate-risk medical devices such as artificial hips should be reliably screened by the Food and Drug Administration (FDA) for safety and effectiveness before those devices are marketed to doctors and patients, according to a new report by the Institute of Medicine (IOM). The FDA currently approves these Class II devices under at 35-year-old process known as 510(k). This process was designed to get devices on the market faster. It can be used when new devices are determined to be sufficiently similar to comparable products that have been previously cleared or were on the market prior to 1975, when the 510(k) ... Read More

Family of deceased 15-year-old girl files Yasmin lawsuit

The family of a 15-year-old North Carolina girl who was taking the birth control pill Yasmin to treat her acne and then died of a pulmonary embolism, are suing the drug’s maker Bayer, claiming the company did not adequately warn users of the potentially deadly health risks associated with its oral contraceptive. The girl was prescribed Yasmin, manufactured by Bayer,  when she was 13 by her dermatologist to help clear up her acne. Her prescription was later changed to the generic Ocella, also manufactured by Bayer but marketed by Teva Pharmaceuticals. Yasmin and Ocella are part of a family of ... Read More

Studies show Yaz, Yasmin cause more blood clots

The U.S. Food and Drug Administration (FDA) and Health Canada have announced they are reviewing studies on the health risks associated with the birth control pills Yaz and Yasmin, as well as their generic equivalents. An early review of studies comparing oral contraceptives with the hormone drospirenone, such as Yaz and Yasmin, with pills containing another type of progestin, show that drospirenone-containing pills increase women’s risk for blood clots. The studies were published in a recent issue of the British Medical Journal. Yaz and Yasmin are made by Bayer, which heavily marketed the pills not only as a contraceptive, but ... Read More

Yaz lawsuits leave women looking for safer birth control options

News of lawsuits filed by women (or the surviving relatives for those who are deceased) who suffered blood clots, strokes, heart attacks, gallbladder damage, and sudden death, after taking the popular birth control pills Yaz and Yasmin, might leave some young women unfazed. After all, despite statistics, the younger generation often feels invincible. But some women are heeding the warnings that hormone contraceptive products have caused serious injury and death, and they are asking for safer, more natural alternatives for birth control. One answer is the Lady-Comp Fertility Monitor. The device uses a thermometer attached to a small monitor with ... Read More

Repeat performance: Alabama lumber company refuses to comply with OSHA safety rules

Last September we blogged about the steep fines a Phenix City, Alabama lumber company faced for violating federal safety standards that could have prevented the death of one worker and the critical injury of another. On Tuesday, the U.S. Occupational Safety and Health Administration announced that the same company, Phenix Lumber Co., continued to disregard willfully violate critical safety measures intended to protect workers, resulting in fines of nearly $2 million and evoking strong words from the agency’s top ranks. “Phenix Lumber continues to put workers at risk by choosing not to implement safety measures that would prevent serious injuries ... Read More