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manufacturers 48 articles

Patients with metal hips should be checked by doctor annually

People who have received metal-on-metal hip replacement systems should be checked by a doctor every year for as long as they have the implant to ensure the implant isn’t failing or poisoning their blood, says the UK regulator of medical devices. Metal-on-metal hip implants were introduced a decade ago as a more durable artificial hip. Traditional hip implants are made with plastic or ceramic parts, but several manufacturers began offering all-metal versions. The design turned out to be a major flaw. Most hip implants can last 20 years or more, but the newer metal-on-metal devices were beginning to fail at a ... Read More

Woman sues transvaginal mesh maker over injuries

“When they come out with a product and make it sound like a cure-all, I don’t know about other women, but I jumped at the chance to get it fixed,” Lee* told The Salt Lake Tribune about the transvaginal mesh device designed to treat her stress urinary incontinence. Unfortunately, the promise was too good to be true. Transvaginal mesh is a surgical mesh device that is used to treat pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. The device is inserted through the vagina to hold up organs that have dropped, or prolapsed. The conditions are ... Read More

Study indicates metal-on-metal hip implants prone to failure

Surgeons should stop using metal-on-metal hip implants because they are prone to failure and may seep toxic metals into patients’ blood, say researchers who conducted safety studies on various hip replacement systems. The study was published this week in The Lancet. Hip implants are traditionally made with plastic or ceramic parts. But newer models have been designed with all metal parts. The all-metal devices have made news in recent months because of reports of early failures and blood poisoning from the metal components. Determining the failure rate is practically impossible in the United States because there is no joint registry. ... Read More

Transvaginal mesh maker develops test to gauge device’s effectiveness

A questionnaire for patients who have received surgical mesh to repair a pelvic floor disorder known as pelvic organ prolapse (POP) has been shown to be a valid measurement tool for determining improvement in sexual function, according to research published in The Journal of Sexual Medicine. The study hopes to shed positive light on a device being reviewed because of safety concerns by the Food and Drug Administration (FDA). POP is a common condition that occurs when the pelvic organs drop, or prolapse, due to childbirth, age or obesity. The condition can cause urinary incontinence, discomfort and pain during sexual ... Read More

UK agency recommends annual review of all-metal hip implants

People who have received any metal-on-metal type of hip implant should be monitored every year for the rest of their lives in order to rule out possible complications, the United Kingdom’s Medicine and Healthcare products Regulatory Agency (MHRA) announced this week. The news comes on the heels of a report by the British Medical Journal (BMJ) and the British Broadcasting Company (BBC) that found problems with the all-metal artificial hips may have been known for years but nothing has been done to ban their use. Hip replacement systems were traditionally made of plastic or ceramic parts, but newer models feature ... Read More

Transvaginal mesh lawsuits consolidated in federal court

Lawsuits against vaginal mesh manufacturers have been centralized in multidistrict litigations (MDL) in West Virginia. Plaintiffs allege that the medical devices made by companies including Boston Scientific Corp. and Ethicon Inc., caused serious injury and debilitating pain. The more than 100 lawsuits have been transferred to federal court in the Southern District of West Virginia. The MDL follows a consolidation of lawsuits in the same jurisdiction against a fourth transvaginal mesh manufacturer, Bard. Hundreds of cases are also pending in state courts across the nation, and several bellwether trials in state court are set for trial in the near future. Transvaginal mesh ... Read More

Consumer groups question safety of expedited medical device approvals

Medical device manufacturers spent more than $33 million last year and used 225 lobbyists to pressure lawmakers to support the Food and Drug Administration’s current practice of allowing moderate-risk devices to be approved without thorough testing for safety and efficacy. The practice has come under fire in recent months, in particular by consumer groups who argue that the agency’s expedited approval process puts patients at risk for serious injury or death. This debate is currently being weighed by members of congress, who will also consider the FDA’s proposal to remedy the situation. The agency is proposing a fee increase for ... Read More

Congress weighs value of expedited approval process for medical devices

Medical device manufacturers are hoping lawmakers sympathize with them and their efforts to put much-needed medical devices on the market sooner for patients in need, rather than with consumer groups who say the approval process for moderate-risk medical devices is flawed and dangerous, and allows products onto the market before they have been proved safe and effective. The $350 million medical device industry spent a whopping $33 million last year and used 225 lobbyists in an effort to sway federal decision makers in their favor despite records from the Food and Drug Administration (FDA) that show that nearly 5,000 deaths in ... Read More

Congress considers medical device approval process

Members of Congress are debating this week whether to speed up the approval process for moderate-risk medical devices to help patients in need even if it puts those patients’ lives at risk. The hearing bring to light a highly debated topic, and one that is pitting medical device manufacturers against consumer groups. These consumer groups include people like Lena Keeton, who nearly died after contracting a flesh-eating bacteria following surgery in 2001 during which she received surgical mesh to treat occasional incontinence. Overcoming the bacterial infection was only part of Keeton’s ordeal. Over the next decade, she has undergone 17 ... Read More

Metal hip implants can cause problems years after removal

Defective metal-on-metal hip replacement systems can cause patients debilitating problems for years after the implants have been replaced, according to research presented at the annual meeting of the American Academy of Orthopaedic Surgeons this week. Surgeons have learned over the past decade that newer versions of hip implants, made with a metal ball that fits into a metal socket, have been failing at a higher rate than traditional hip implants made of ceramic or plastic parts. Typically, most hip implants fracture, loosen, or dislocate over a decade or two due to wear and tear. But many of these metal implants, ... Read More