Medtronic under greater scrutiny as more of its products run into problems
Medical device maker Medtronic have been making the headlines for all the wrong reasons lately. Priding itself as the “global leader in medical technology, services, and solutions”, Medtronic have been at the centre of a fair few recalls for defects and risks that have arisen from the use of their products.
In the latest issues, scrutiny has come from issues with their products and an alleged lack of warning for equipment incompatibility.
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Opioid lawsuits for overuse and addiction
Recently, we’ve seen a greater reliance on drugs from doctors, which include addictive painkillers like opioids. The addiction has been reported as a global epidemic, with the U.S. noting it as “the worst drug epidemic in U.S. history“.
Drug manufacturers and distributors have now found themselves in hot water as a result of the allegations.
At least 25 states in the U.S. have taken legal action against opioid manufacturers for the alleged unprecedented effect it has had on communities across America, and here in the U.K., we’re concerned we may be facing a similar epidemic.
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Depression and chronic pain relief drug, Duloxetine, recalled after failing tests
The drug Duloxetine, more commonly known as its brand name Cymbalta, is generally used to treat depression, anxiety, and chronic pain. It’s an active ‘serotonin-norepinephrine reuptake inhibitor’, providing pain relief for patients with diabetes or sufferers from chronic or widespread pain.
The drug is commonly prescribed to people with arthritis and fibromyalgia. However, select batches of the Torrent Dutor Gastro-resistant Capsules have been recalled by the Medicines and Healthcare products Regulatory Agency (MHRA) because “out of specification results for dissolution were obtained during routine stability testing”.
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14,000 Medtronic ventilators recalled
Regulators have reportedly issued a recall for a number of medical ventilators manufactured by Medtronic.
The company’s New Port HY70 and HT70 Plus ventilators are being recalled amidst concerns that the devices may suddenly shutdown or reset. There have so far been 12 reported cases whereby a reset was suddenly initiated without warning. Thankfully, no patients have yet suffered an injury!
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The reported danger of Intersurgical’s BVM resuscitation device
A reported manufacturing fault of a medical device has caused a great deal of concern within the healthcare industry. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a field safety notice to notify healthcare providers and users alike.
Due to a reported manufacturing fault, the Bag-Valve-Mask (BVM) manual resuscitation system could cause injury or even death as the valve may become stuck during storage, possibly resulting in the intended airflow not being delivered. Consequently, there may be a delay in the treatment.
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Takata files for bankruptcy as a result of exploding airbag scandal
The Takata airbag recall is one of the biggest automotive recalls in history. The company started producing airbag inflators in the late 1990s, and around the year 2000, Takata discovered some of their airbag inflators weren’t functioning properly, and even found some had erupted during tests.
The first recorded incident reportedly happened in May 2004 where a driver’s side bag ruptured in a Honda Accord. It was not until half a decade later that Honda recalled more than 500,000 airbags for the defect to be rectified, and regulators didn’t start investigations until June 2014.
Now, the scale of the issue has resulted in the Japanese manufacturer filing for bankruptcy.
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Medical device alert issued for Prismaflex Haemofiltration machines
A medical device alert has been issued warning hospitals and healthcare institutions that Prismaflex Haemofiltration machines are susceptible to software failure.
Machines manufactured by Baxter, and installed with the 6.10 version of software, may not compute information about syringe size and the brand of syringe used. As a result, the machine may revert back to default settings, which means it will work at the lowest possible plunger speed which may therefore lead to under-dosage.
When under-dosing occurs, a lack of anti-coagulants may be added to the blood. Without carefully measured anti-coagulants, the patient’s blood may then be at a high risk of clotting, which can of course lead to potentially serious consequences.
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Unomedical concentration oxygen mask recalled over dangerous defect
Unomedical concentration oxygen masks provide vital oxygen for patients. However, the Medicines and Healthcare products Regulatory Agency (MHRA) has found that a manufacturing fault could be disrupting supply, which could lead to oxygen deprivation for patients using the faulty oxygen masks.
This has led to an increased risk of Hypoxia (deficiency in the amount of oxygen reaching the tissues).
Manufacturer ConvaTec issued a voluntarily recall on 10th May 2017 over concerns of health risks to patients. ConvaTec also distributes the affected oxygen masks to multiple countries in several European countries as well as Rwanda and Saudi Arabia, making this a far-reaching issue.
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Medtronic: “Infuse lawsuits coming to a close”
Medical device company, Medtronic, has recently suffered a lengthy legal headache when the company faced allegations of defrauding shareholders by reportedly covering up negative side-effects of its Infuse bone growth product for 10 years.
Infuse is a genetically engineered protein that causes bones to fuse for use during lower spinal surgery; intended as an alternative to bone grafts. Thousands of patients complained that the product was used inappropriately and that it had caused permanent and devastating injuries.
These were allegedly covered up.
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Exploding Takata airbags: many millions involved in recalls
There have been multiple calls to get Takata inflators out of vehicles and off the roads for several years, and after a crash where a Takata airbag reportedly nearly caused a woman’s death, these calls are getting louder.
Karina Dorado’s trachea was reportedly punctured by shrapnel from a Takata inflator. The crash, which happened on 3rd March 2017 in Las Vegas, should’ve been just a minor collision, but things escalated quickly. Ms Dorado was rushed into a trauma centre where surgeons removed pieces of the airbag device that had damaged her vocal cords.
She is still being treated for neck injuries.
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Cancer associated with breast implants used in reconstructive surgery
Insurance agent Raylene Hollrah was diagnosed with breast cancer in 2007. The successful businesswoman, who owns her own insurance company, made a life changing decision; she underwent chemotherapy and had her breasts removed and reconstructed.
Hollrah made the brave decision to go through painful and gruelling surgery and treatment in the hopes she would free herself from breast cancer. Unfortunately, six years later, Hollrah was diagnosed with cancer again.
Shockingly, it wasn’t a return of the breast cancer; it was a “rare malignancy of the immune system” that was reportedly caused as a result of the breast implants used in her reconstructive surgery…
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Call for U.K. public inquiry into vaginal mesh implants
Senior doctors in the U.K. have called for a public inquiry into the use of vaginal mesh surgery. This comes after growing concerns that patients who have undertaken the surgery have been scarred for life.
Vaginal mesh implants are a net-like implant usually made out of polypropylene plastic and are used to treat pelvic organ prolapse, and stress urinary incontinence in women who may have these conditions as a result of hysterectomy, menopause or childbirth.
The problems that can occur if the devices fail can be catastrophic.
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