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manufacturers 48 articles

Second transvaginal mesh lawsuit against Boston Scientific goes to trial

The second bellwether trial involving injuries from Boston Scientific’s transvaginal mesh device is underway in Massachusetts state court, and plaintiffs are hoping for a different outcome than the first. Plaintiff Maria Cardenas is suing the medical device company claiming she suffered injuries from Boston Scientific’s defectively designed transvaginal mesh, also known as a bladder sling. The company is facing thousands of similar lawsuits in state and federal court over its pelvic mesh products, however Cardenas’ is the only the second to go to trial. The first bellwether case was brought by plaintiff Diane Albright, who claimed the company’s Pinnacle Pelvic Floor ... Read More

FDA provides guidance to help medical device manufacturers gain faster marketing approval

The Food and Drug Administration (FDA) is providing manufacturers with information to help them win faster approval for medical devices deemed “substantially equivalent” to other devices, even if the technology of the new device is different or carries different risks. The guidance is designed to prevent defective medical devices from passing through the agency’s abbreviated 510(k) approval process, which allows faster clearance to moderate risk devices if they are similar to other devices currently on the market. The FDA has been revamping the 510(k) process since it was revealed four years ago that the faulty Johnson & Johnson DePuy ASR ... Read More

Judge denies Ethicon’s request for new transvaginal mesh trial

Johnson & Johnson subsidiary Ethicon has been denied a new trial that would have struck an $11.1 million verdict in the first bellwether trial over allegedly defective transvaginal mesh. “There was strong evidence presented and multiple sources of evidence that in fact there were many problems with this product,” Atlantic County Superior Court Judge Carol Higbee said in court. Despite the ruling, Ethicon spokesman Matthew Johnson said the company isn’t giving up. “We will be filing an appeal in this case as we believe the jury’s verdict and damage awards were not supported by the evidence presented at trial,” he ... Read More

FDA sets new guidelines for manufacturers of infant formula

The Food and Drug Administration (FDA) has set new standards for manufacturers of infant formula in an ongoing effort to ensure the products are safe and support healthy growth in the babies who consume them. The new standards come from an interim rule that was published last February, and take into consideration comments received after that time. The finalized rule includes modifications and clarifications, and sets a Sept. 8, 2014, date for manufacturer compliance. Under the new rule, manufacturers of infant formula are required to test their products for harmful pathogens, and disease-causing bacteria such as Salmonella and Cronobacter. Manufacturers are ... Read More

Study links testosterone therapy to brain damage

Testosterone replacement therapy may cause brain damage in Caucasian men, a new study suggests, adding yet another strike against the increasingly popular hormone treatment. Testosterone treatments are approved to boost levels of the hormone in men experiencing symptoms of so-called Low-T, such as a diminished sex drive, fatigue, weight gain and muscle loss. In recent years, prescriptions for testosterone supplements have skyrocketed in the United States, leading many experts to worry that the drug is being given to men who don’t necessarily need it. In its natural form, testosterone helps protect the brain against free radicals, which can damage brain ... Read More

Man says his stroke was caused by AndroGel testosterone treatment

Ed Downes’ stroke seemed to come out of nowhere. Ed, who was in his upper 40s at the time, was taking medication for hypertension and attention deficit disorder (ADD), but was otherwise healthy. When he began to lose interest in sex and his energy level plummeted, he, like hundreds of thousands of other men, followed the advice of a drug company’s television commercial and had a “conversation with his doctor” to see if he was suffering from low testosterone, or, as the advertisement called it, “Low T.” Ed was prescribed AndroGel, a testosterone replacement gel, which he took for two years. ... Read More

Metal hip manufacturer faces new lawsuits alleging defective design

At least five new lawsuits were filed against Stryker Corp., and its subsidiary Howmedica Osteonics Corp., claiming that the companies’ hip implant was defective, causing injuries and poisoning blood. The lawsuits involve the Accolade TMZF hip stem and LFIT anatomic V40 femoral head. Stryker already is facing more than 500 similar lawsuits over other artificial hip models, the Rejuvenate and ABG II modular-neck stems. According to the complaint, the titanium hip stem can corrode when it is used with the femoral heads, which are made from cobalt and chromium. When the metal corrodes inside the body, it can inflame tissue, ... Read More

Female incontinence treatment linked to serious complications

More than 20 million women in the United States suffer from urinary incontinence, but devices intended to remedy the problem are at the center of thousands of lawsuits by women who claim the treatments ruined their lives. Jennifer Ramirez says her incontinence wasn’t a serious problem for her. She opted to have transvaginal mesh implanted to keep the problem from getting worse following a hysterectomy. Now, she lives in constant pain. Just talking about it brings her to tears. “Now my life has to revolve around having a restroom right there because when you have to go, you have to ... 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

Transvaginal mesh side effects likely caused by defective design

Two women were told they could no longer have sexual intercourse with their partners after suffering complications related to their transvaginal mesh. “We’ve not got a sex life. It’s actually taken a toll on my marriage,” Linda, whose name was changed, told BBC. “I don’t even go to the doctor. I don’t even bother.” Both women were implanted with transvaginal mesh, a type of surgical mesh used to treat pelvic organ prolapse or stress urinary incontinence, common conditions that affect women due to childbirth, age or weight gain. Both women say they were injured by the devices and live in ... Read More