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infections 92 articles

Surgeon: Metal hip implant failures led to ‘severe patient wreckage’

“I’d seen patients coming into the clinic complaining of groin pain. I saw it once and then again and then again and again,” Surgeon Antoni Nargol told Four Corners, an investigative news program for ABC News Australia. Nargol was referring to patients who had received ASR metal-on-metal hip replacement systems made by Johnson & Johnson subsidiary DePuy Orthopaedics. The devices were recalled in 2010 after mounting reports of premature failures and infections caused by heavy metal blood poisoning. New research shows that Johnson & Johnson knew the devices were defectively designed as early as 2006 – four years before the ... Read More

Maine woman sues makers of transvaginal mesh

Dory Ames from Maine is one of the latest women to file a lawsuit against the makers of transvaginal mesh claiming the device caused serious injuries. Manufacturers of these bladder slings face tens of thousands of lawsuits alleging the companies marketed the devices knowing they were defective and could cause harm to women. Transvaginal mesh is a type of surgical mesh used to treat common pelvic floor disorders known as pelvic organ prolapse and stress urinary incontinence. The mesh is inserted through the vagina to hold up organs that have dropped or protruded due to childbirth, age, weight gain, or ... 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

Family says defective metal-on-metal hip implant caused mother’s brain cancer

A woman who had filed a lawsuit against Johnson & Johnson for its defective metal-on-metal hip implant has died of an aggressive brain cancer, a disease her family believes was caused by blood poisoning from her corroding artificial hip. Bharucha had broken a hip when she suffered a fall and in 2007 was fitted with Johnson & Johnson’s DePuy ASR hip replacement system. The surgery did not relieve her pain or help her regain her mobility. In fact, she grew increasingly worse. By 2011, a year after the device was recalled due to premature failures, Bharucha had revision surgery to ... Read More

FDA wants to reclassify transvaginal mesh as high-risk medical device

The Food and Drug Administration (FDA) proposed reclassifying transvaginal mesh devices from moderate-risk to high-risk, requiring manufacturers to submit a premarket approval application for the agency to evaluate a device’s safety and efficacy before the device can be approved for marketing. Transvaginal mesh is a type of surgical mesh that is inserted through the vagina to treat common pelvic floor disorders such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh holds up organs that have dropped due to the stress of childbirth, obesity or age, causing symptoms such as incontinence, pain during sexual intercourse, and general discomfort. ... Read More

Class action lawsuit filed by Fitbit Force fitness tracker wearers who developed skin rashes

A class action lawsuit was filed against Fitbit by people who say they should be compensated for the injuries they suffered while wearing the company’s Force fitness tracker wristband. The Fitbit Force is the latest product to be released by Fitbit. The popular wristbands sell for about $130. The bands are made of silicon and have a small display and sensors that measure motion in order to track steps taken, calories burned, distance traveled, and sleep patterns. The device syncs with computers and smart phones. Last year, consumers reported developing skin rashes and other skin problems while wearing the device. ... 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

FDA cracks down on compounding pharmacies, issuing warning letters for unsanitary practices

The Food and Drug Administration (FDA) is coming down hard on compounding pharmacies, issuing warning letters for unsanitary conditions and producing drugs without individual prescriptions. The action comes four months after congress passed the Drug Quality and Security Act, which puts compounding pharmacies that outsource their products under FDA oversight instead of being governed by state pharmacy boards like traditional pharmacies. Nora Apothecary and Alternative Therapies, Pallimed Solutions Inc., and Wedgwood Village Pharmacy received warning letters outlining sterility issues with facility procedures from visible sterile drug contaminants to inadequate clean rooms and monitoring programs. The FDA’s oversight into compounding pharmacies ... Read More

Woman files lawsuit against makers of defective transvaginal mesh

“I get stabbed a thousand times a day,” Frances Shulte told The Gazette. The constant pain prevents the Coralville, Iowa, resident from comfortably moving around or going to the bathroom. She never dreamed that the surgery to correct a pelvic floor disorder would cause her chronic pain and disability. “People don’t understand that I’m in pain every day,” she said. Frances’ ordeal began in 2005, when she had surgery to correct her stress urinary incontinence. Doctors inserted a type of surgical mesh, also known as transvaginal mesh or a bladder sling, into her body to hold up organs that had ... Read More

Johnson and Johnson wants to conceal failure to preserve evidence in transvaginal mesh lawsuit

Johnson & Johnson is asking a West Virginia federal judge not to allow the plaintiff in an upcoming bellwether trial in multidistrict litigation over injuries caused by its transvaginal mesh to tell jurors that the company failed to preserve evidence. Johnson & Johnson claims the issue is no longer relevant to the case. U.S. Magistrate Judge Cheryl Eifert found the consumer health care giant had lost potential evidence in the case and suggested that jurors may need to hear about circumstances such as when a plaintiff’s physician relied on evidence provided by a sales representative whose records were destroyed. The ... Read More