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medical device 90 articles

Canadian woman files bladder sling lawsuit

Jane Dowdall had no idea she would end up in so much pain following surgery to fix her urinary incontinence. “The pain is like a migraine headache… from knees to naval,” she told CTV. “Sometimes it’s a burning, sometimes it is a sharp pain.” Jane underwent a TVT-O, or Tension Free Vaginal Tape – Obturator, procedure. The method of securing the mesh to the body is through the Obturator Foramen, a hole created by the ischium and pubis bones of the pelvis through with nerves and muscles pass. It is a type of transvaginal mesh, also known as a bladder ... Read More

FDA advisory panel to review safety of metal-on-metal hip implants

The safety of metal-on-metal artificial hips will be investigated by a Food and Drug Administration (FDA) expert panel this June, according to a press releases issued by the agency. The hip implants have come under scrutiny over the past few years after mounting complaints from patients and studies that show the devices are prone to premature failure and can poison patients as they wear over time. FDA expert panels are assigned to review drugs and medical devices and make recommendations on corrective steps, whether it is to order stronger warnings about a product or ban it from the market. The ... Read More

Website documents family’s ‘personal nightmare’ with transvaginal mesh

“Our journey with TVT (transvaginal mesh) has been a hard, long, personal nightmare that we learned we are not alone in,” writes Dave Sawyer, husband of Teresa, on their website, “All Meshed Up.” Teresa was implanted with transvaginal mesh in February 2011 to treat her stress urinary incontinence (SUI). Since then, Teresa has endured 25 infections and five additional surgeries after the mesh eroded into her cervix. “We have had the honor to meet other women that are mesh survivors and, sadly, learned of 18 women that fell lethally victim to the mesh,” Dave writes. A mission statement is forefront ... Read More

Transvaginal mesh was in use long before it was approved by FDA

Johnson & Johnson sold a surgical mesh device used in pelvic floor surgeries for three years before it was approved by the Food and Drug Administration (FDA). Now, more than 550 women have filed lawsuits against the company claiming they were injured by the transvaginal mesh. Transvaginal mesh is a type of surgical mesh that is used to treat conditions such as pelvic organ prolapse and stress urinary incontinence. The mesh is implanted into the vaginal wall to shore up organs such as the bladder or uterus. The devices have come under fire in recent months after mounting complaints of injuries ... Read More

Public overwhelmingly supports stronger medical device oversight

A Consumer Reports poll shows the public overwhelmingly supports more government oversight of medical devices. The poll was released just as House and Senate Committees released draft legislation to change the way medical devices are approved by the Food and Drug Administration (FDA). Currently, the vast majority of medical devices are approved by the FDA through an accelerated program that allows devices to be approved with clinical trials to evaluate safety and efficacy if there are similar devices already on the market. This process was established several years ago to help move a backlog of devices through the system and ... Read More

DePuy ordered phase-out of defective hip implant after FDA inquiry

Johnson & Johnson decided to phase out one of the hip implants made by its subsidiary DePuy Orthopaedics and sell off its inventory shortly after receiving an inquiry from the Food and Drug Administration (FDA) that questioned the device’s safety and efficacy. The federal agency was asking the drug and medical device manufacturer for safety data on its metal-on-metal ASR XL Acetabulator hip replacement and hip resurfacing systems, and informed the company that blood tests in patients who had received the implants showed “high levels of metal ions.” The latest news adds more concern that DePuy and Johnson & Johnson ... Read More

Patients with all-metal hip implants should be monitored yearly

The United Kingdom’s health regulator is recommending that patients who have received hip replacement systems made from all-metal parts be monitored once a year for as long as they have the implant. The news comes just after the British Medical Journal (BMJ) and the British Broadcasting Company (BBC) announced the results of a joint investigation into problems with the medical devices. Traditional hip implants are made with ceramic or plastic parts, but newer hip devices have employed an all-metal design built to hold up better over time. However, they appear to to be less durable than traditional implants. The flaw ... Read More

FDA warns surgeons about malfunctioning brain mapping device

A machine used by physicians to conduct brain mapping procedures for patients with brain tumors and seizure disorders – including those caused by Traumatic Brain Injuries (TBI) – is being recalled because of a malfunction and short circuiting issue that can result in the surgeon resecting the wrong brain tissue. This recall is classified as a Class 1, which is the most serious type of recall, involving situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. The recall involves the CareFusion is recalling Nicolet Cortical Stimulator Control Unit, ... 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