Tagged Articles

complications 149 articles

Researchers find metal ion concentration, device brand may predict hip implant failure

The amount of metal ions in the blood and the type of hip implant may predict premature failure of metal-on-metal hip replacements, according to a team of United Kingdom researchers. Researchers reviewed data from 299 resurfacing procedures in 278 patients with various brands of hip implants. The patients had reported complications that were likely related to high levels of metal in their blood. Patients were put through a blood metal ion screening protocol, ultrasound scanning, and joint aspiration to determine the level of cobalt concentration. Researchers found that blood-cobalt concentration and the type of device used were significant risk factors ... Read More

GSK halts production of chickenpox vaccines due to quality concerns

GlaxoSmithKline (GSK), one of the world’s leading vaccine manufacturers, has stopped deliveries of two chickenpox vaccines for children after finding some batches were substandard. The quality issue involves two vaccines containing a chickenpox, or varicella, component – Priorix-Tetra, which combines vaccines for measles, mumps, rubella and varicella (MMRV); and Varilrix, a single-shot vaccine for varicella. The batches in question were produced at GSK’s Wavre, Belgium, facility. The company says shipments are expected to resume in March. Vaccines currently in circulation are safe, GSK says. The vaccines are also made by other drug companies, which should be able to cover any ... Read More

New documentary to portray the severity of transvaginal mesh injuries

A new documentary film currently in production will feature a number of women from the U.S., Canada, and other countries whose bodies, and subsequently their lives, were devastated after being implanted with transvaginal mesh products designed to correct pelvic organ prolapse, urinary incontinence, and other conditions affecting the position of the pelvic organs. The documentary, called Enmeshed, is a collaboration between Philip Courter of Courter Films and Jane Akre, editor of the Mesh Medical Device News Desk, a watchdog group that monitors the medical mesh industry and the ways in which transvaginal mesh devices, hernia patches, and other polypropylene mesh ... Read More

3 medical devices that can harm you

Medical devices are vitally important to the industry. They vary in complexity and application, from tongue depressors and disposable gloves to implants and prostheses. Because they are used to diagnose, prevent or treat disease or other conditions, these items are regulated by the Food and Drug Administration (FDA) to ensure their safety and efficacy. However, this does not guarantee the devices don’t have hidden design flaws that can cause serious health risks. Here are three commonly used medical devices that were designed to help people, but ultimately caused more harm that good: 1. Transvaginal mesh – Also known as vaginal ... Read More

Judge delays C.R. Bard transvaginal mesh trial amid settlement talks

A federal bellwether trial against transvaginal mesh maker C.R. Bard that was scheduled to start Dec. 3 has been pushed back to January 10, 2014. C.R. Bard is one of six transvaginal mesh manufacturers facing more than 30,000 personal injury lawsuits combined for multidistrict litigation (MDL) in a Charlestown, W.Va., federal court. The rescheduled case was filed on behalf of a woman who alleges she was seriously injured by a Bard Avaulta vaginal mesh implant. Her lawsuit is one of four cases against C.R. Bard selected for the first round of bellwether trials, which are intended to consolidate discovery and ... Read More

Johnson & Johnson accused of destroying or losing transvaginal mesh documents ahead of trial

Johnson & Johnson’s Ethicon unit destroyed or lost more than a decade of documents related to its Gynecare Prolift transvaginal mesh, lawyers representing plaintiffs suing the manufacturer over mesh injuries allege. The plaintiffs’ lawyers have asked that a West Virginia federal court bar Johnson & Johnson and Ethicon from relying on certain defenses in bellwether trials planned for this year because of the missing documents, potentially numbering in the hundreds of thousands. More than 30,000 lawsuits against five manufacturers of transvaginal mesh, including Johnson & Johnson’s Ethicon unit, have been combined for multidistrict litigation under U.S. District Judge Joseph Goodwin ... Read More

Judge schedules first of Boston Scientific transvaginal mesh cases for March trial

A West Virginia federal judge overseeing personal-injury litigation against six transvaginal mesh manufacturers has set a trial-start date of March 10, 2014 for the first lawsuit naming Boston Scientific as a defendant. The Natick, Mass.-based medical device manufacturer faces more than 6,400 personal-injury claims filed in U.S. District Courts by women who allege the polypropylene devices, which are designed to correct pelvic organ prolapse and some forms of urinary incontinence, are defectively designed and cause a multitude of complications, including mesh erosion, infection, bleeding, organ perforation, and severe pain. Those cases have been consolidated for multidistrict litigation (MDL) in Charleston, ... Read More

Fresenius urges dialysis patients to get flu shots despite mounting GranuFlo lawsuits

Fresenius Medical Care, the world’s largest provider of dialysis products and services, is strongly encouraging dialysis patients to get a flu shot. The company is even offering free flu vaccinations to all of its dialysis patients and employees, a generous offer considering the company’s poor track record with communicating important health issues to patients and staff. The company is currently facing numerous wrongful death, personal injury and false advertising lawsuits stemming from its dialysis concentrates GranuFlo and NaturaLyte. The products are used to help balance electrolytes in the blood during dialysis. One of the ingredients in the solutions converts to ... Read More

Several transvaginal mesh manufacturers involved in lawsuit settlement talks

Settlement talks are currently underway between manufacturers of transvaginal mesh and women who say they suffered serious complications from the defectively designed products. Attorneys for Boston Scientific, Coloplast, Cook Medical, and C.R. Bard entered into discussions to resolve the tens of thousands of lawsuits waged against them. The only manufacturer that did not join the discussion was Ethicon, a subsidiary of Johnson & Johnson. There are more than 30,000 lawsuits against the five companies that are engaged in settlement talks. However, that number is expected to grow to upwards of 50,000 as more plaintiffs join in the settlement proceedings. Transvaginal ... Read More

DePuy settles ASR metal hip complaint before trial start

Johnson & Johnson has settled a personal-injury lawsuit that accused its DuPuy Orthopaedics unit of manufacturing defective metal-on-metal hip replacement devices. The lawsuit had been selected as a bellwether case among several other cases DePuy faces over its ASR hip implants, and was destined for an October 15 trial in San Francisco Superior Court. In March, a Los Angeles jury ordered DePuy to pay Loren “Bill” Kransky, a retired prison guard, $8.3 million in damages for injuries he allegedly received from an all-metal ASR hip device made by DePuy. Mr. Krannsky’s case was chosen as the first of more than ... Read More