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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

Bayer markets Mirena-like IUD for adolescents despite Mirena IUD injury lawsuits

A new intrauterine device is being marketed in the United States with sexually active adolescents in mind. Skyla, made by Bayer Healthcare, is raising concerns among some experts not because it is geared toward younger women, but because some IUDs, especially the Mirena, also made by Bayer, have been associated with injuries, some of which have been serious. Skyla is a new version of Bayer’s Mirena. Both deliver a steady dose of the hormone levonorgestrel, but Skyla is smaller than the Mirena, lasts up to three years as opposed to five years with Mirena, and contains less of the hormone ... 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

Mirena IUD complication reports, lawsuits increase

Women using the Mirena intrauterine device (IUD) for birth control and/or to curb heavy menstrual bleeding should be aware that the devices have been linked to serious injuries. Not only has the Food and Drug Administration (FDA) seen an increase in complaints related to the devices, recent court records show the number of lawsuits alleging injuries due to perforation have risen 17 percent, according to DrugNews, a resource center. DrugNews gives people who use popular prescription drugs or medical devices access to the latest safety alerts, recalls, studies, and legal news. The site recently added a study from the Society ... Read More

Lawyers ask FDA to investigate DePuy after alleged wrongdoing surfaces in ASR hip trials

Lawyers representing patients allegedly harmed by metal-on-metal hip implants have called upon the U.S. Food and Drug Administration (FDA) to investigate allegations of wrongdoing in DePuy Orthopedics, a division of Johnson & Johnson that manufactured and sold and subsequently recalled tens of thousands of defective metal ASR hips. The lawyers say new evidence emerged in testimony given during the first two bellwether personal-injury trials indicating DePuy broke federal laws when it concealed information that could have spared thousands of patients from injuries allegedly brought about by its ASR metal hip implants. That evidence had been sealed by court order until ... Read More

Personal injury lawsuits mount against maker of Mirena IUD

More than 70,000 complaints have been filed with the Food and Drug Administration (FDA) since 2000 regarding the Mirena intrauterine device (IUD), a Scripps investigation reveals. Many of the reports involve serious complications including device dislocation and perforations. Some complications required hospitalizations and/or surgical procedures. The Mirena IUD, made by Bayer Healthcare, is a flexible, T-shaped device that is inserted into the cervix. It releases a steady dose of the hormone levonorgestrel to prevent pregnancy. It is also used to treat heavy menstrual cycles in women who use IUDs for contraception. It is one of two IUDs approved in the United ... Read More

Large diameter metal-on-metal artificial hips fail more often than other implants

Hip replacement surgeries are among the most performed surgical procedures, but in some cases the device fails, resulting in revision surgery to remove and replace the device. On average, artificial hips can last 20 years or more before being replaced, but one type and size of hip implant was found to fail more often than traditional hip implants. Last month, the Canadian Institute for Health Information released a report that studied the factors influencing how long artificial hip implants lasted. Researchers reviewed data from 56,942 surgeries throughout Canada (except Quebec) from 2003-2011. They found that metal-on-metal large-diameter modular implants in particular ... Read More

Canadian report reinforces dangers of metal-on-metal hip implants

Hip-replacement patients fitted with all-metal large-diameter modular implants, such as DePuy’s ASR hip devices, are more than three times likely to need to need their devices replace prematurely, according to a new report by the Canadian Institute for Health information (CIHI). While the Canadian report doesn’t shed new light on the risks many metal-on-metal hip devices pose, it echoes the findings of many previous studies and reports that have found certain types of all-metal hip implants are, by design, prone to fail early and injure the patient. The CIHI based its conclusions on voluntary data for 56,942 hip-replacement surgeries performed ... Read More

Lady Gaga reveals she was close to needing a full hip replacement

Lady Gaga was possibly one performance away from needing a full hip replacement after an injury forced her to postpone, then cancel, the remaining 22 gigs on her Born This Way Ball tour, the artist revealed in a recent interview. In February, Gaga’s tour company announced that she suffered from a “labral tear of the right hip,” which is essentially a tear of the cartilage that forms the outside socket of the hip joint. A labral tear is usually painful and immobilizing, but Gaga’s case turned out to be exceptionally severe, she told Women’s Wear Daily. “My injury was actually ... Read More

First New Jersey case alleging DePuy ASR hip injuries to start in October

The first of several hundred ASR-hip lawsuits filed in New Jersey state courts against DePuy Orthopedics and parent company Johnson & Johnson has been scheduled to start October 21. The bellwether case, selected as a representative case to help the court and litigants understand how the rest of the litigation will proceed, will be heard before Judge Brian Marinotti in the Superior Court of New Jersey for Bergen County. More than 600 lawsuits against DePuy alleging injuries from its ASR metal hip implants are pending in New Jersey, where they have been consolidated for Multi-County Litigation (MCL). Johnson & Johnson ... Read More