Category: Medical
Risks of infection for patients where Zimmer Biomet hip and trauma instruments are used
Zimmer Biomet have been in the news in recent years over knee replacement device problems, which is one of many stories where medical manufacturers have been in the spotlight for medical device compensation claims.
You only need to look at the massive Metal-on-Metal hip implant cases to see just how big these kinds of claims are.
In this latest story, Zimmer Biomet are recalling specific hip and trauma instruments over potential risks of infections to patients.
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MHRA announce recall of rectal / pharyngeal temperature sensors
Rectal / pharyngeal (orally inserted) temperature sensors manufactured by Teleflex are a part of a recent recall published by the Medicines and Healthcare Regulatory Authority (MHRA).
The issue with the devices may lead to a misdiagnosis where an inaccurate temperature reading is noted by a medical professional.
With body temperatures often being pivotal to medical diagnosis, this recall is a serious one where patients may be at risk of incorrect advice and treatment off the back of inaccurate temperature readings.
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Lab error leads to thousands of cervical screening tests being reviewed
A laboratory run by Pathology First, working on behalf of Basildon and Thurrock NHS Foundation Trust, are having to redo thousands of cervical screening tests for cancer after an error was discovered.
The samples affected, which were taken between April 2016 and September 2017 for women aged between 24 and 29 who had smear tests, as well as a number of women in their 60’s, are being re-screened independently.
The results held by the lab were classed as negative, but having had some 2,500 samples re-screened, 17 women have reportedly been invited for further assessments.
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Aquilon nebulisers – CE mark withdrawn and supply ceased, but many have remained on the market
Despite withdrawal of the CE safety marking for Aquilon series of nebulisers, manufactured by AFP Medical, the nebulisers have still been placed on the market. A number of devices may have been sold despite the withdrawal of the CE marking, which means the safety of the product cannot be guaranteed.
CE safety certification is vital for consumer and supplier confidence in a product, and when it comes to medical products, such approval – or withdrawal, as is the case here – can be even more important.
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UK government investigating the scale of harm caused by vaginal mesh implants
Our legal team have been assisting people in various situations involving harm caused by vaginal mesh implants.
The UK government review update is welcome news.
Years after the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) investigated issues and decided against recalls and bans, the National Institute for Health and Clinical Excellence (NICE) has suggested the surgery should be banned, and New Zealand have become the first country in the world to put an outright ban in place.
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Birth defects reportedly caused by in-utero exposure to Epilepsy Drug
A drug that helps control epileptic seizures has been reportedly linked to birth defects and should not be used by pregnant women or women of child-bearing potential.
Depakote was created by French pharmaceutical drug company Sanofi back in 1967. The British equivalent, Epilim, has been available since 1973.
The drug has been used around the world and has gained regulatory approval for treatment of epilepsy, with variations of the drug introduced in 1995 for bipolar manic episodes, and in 1996 to prevent migraines. But, a generation later, it has been revealed the drug can cause severe birth defects at a significantly high percentage.
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PharmaTech LLC packs up manufacturing plant after its liquid drugs are found to be contaminated with B.Cepacia bacteria
All of PharmaTech LLC’s liquid drugs made at one manufacturing plant have been recalled, with regulators advising consumers not to use them.
Reportedly, the drugs have been contaminated with Burkholderia cepacia bacteria.
Patient infections have been linked to the drugs, meaning regulators are warning against the use of their products. Notably, this is not PharmaTech’s first brush with the law. Regulators have been involved with them three times in less than a year for similar issues involving the bacteria.
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MHRA issue “Class 4” drug alert warning for Focus Pharmaceuticals after barcode errors found on 8 medicinal products
The Medicines and Healthcare Products Regulatory Agency (MHRA) issued a Class 4 (caution in use) warning over eight Focus Pharmaceutical medicinal products after a problem was found with the barcodes.
The packaging fault may interfere with prescriptions as the wrong product may be identified when they’re scanned.
The medicines themselves have no reported faults and the rest of the packaging including the name, strength and pharmaceutical form of the medicine is correct as far as the manufacturer and the MHRA are aware.
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Suicide statistics may have allegedly been incorrectly reported in drug trials
GlaxoSmithKline (GSK) is currently engaged in a fierce legal battle over its antidepressant pill, Paxil (Seroxat in the U.K.).
Marketed as an antidepressant, Paxil is supposed to reduce the risk of suicide in users.
When it was first made for production, GSK conducted clinical trials to test how effective the drug was. In 1989, it presented the drug to regulators along with the results that indicated Paxil was much safer than taking a placebo.
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Medtronic recalls disposable diabetes infusion sets over risk of causing hypoglycemia
Medical device manufacturer Medtronic Plc is recalling disposable diabetes infusion sets as a possible defect may trigger excessive doses of insulin to the diabetic user, putting them at risk of hypoglycemia.
The recall reportedly affects insulin infusion sets distributed all over the world.
The device, connected to an insulin pump, features thin plastic tubing with a needle or cannula at the end to carry insulin into the body when needed. However, apparently, “one in every two million” sets may contain a “complication”.
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NICE calls for U.K. surgery ban on vaginal mesh implants
The infamous mesh implants that’s sewn into vagina walls which has reportedly caused multiple injuries and excruciating pain for many women may now be finally banned for good in the U.K.
Those women who had the ‘minor’ routine surgery to help treat organ prolapses and mild incontinence, but then went on to suffer serious and painful complications has prompted the U.K.’s National Institute for Health and Care Excellence (NICE) to recommend that the implants shouldn’t be used in treatment any more at all, only for research.
This is a change to previous NICE guidelines that were more about taking extreme precautions when using the mesh devices.
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Hospitals and Doctors warned over using Intercept Pharmaceuticals liver disease drug
Regulators have issued Doctors and Hospitals with a warning over Intercept Pharmaceuticals liver disease drug after 19 people have reportedly died after taking too much of it.
Regulators also noted 11 cases of serious liver injury after taking the drug as well.
The warning prompted the company’s shares to reportedly plummet down by 24.9%, to $73.70. The drop is thought to be the company’s biggest loss since November 2014, Bloomberg reports.
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