Category: Medical

The class-action suit against Sanofi over epilepsy drug linked to birth defects

Thousands joined together to bring a class action case against French drug company Sanofi for allegedly not warning expectant mothers of the adverse side-effects of taking the epilepsy drug Depakine/Depakote. French newspaper Le Canard Enchaine reported that over 10,000 pregnant women were given this drug between 2007 and 2014, and it’s suspected that around 450 children may have been born with congenital defects due to exposure of the drug whilst in the womb.

Epilepsy drugs have been in focus in the news recently, and when it comes to birth defect claims, it’s always a very serious matter indeed.
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EpiPen maker accused of failing to investigate complaints of malfunctioning products that reportedly led to injuries and deaths

Regulators have made serious accusations that giant healthcare products manufacturer Pfizer are not investigating complaints made over alleged EpiPen device failures.

The lifesaving device contains epinephrine; a hormone that can relieve symptoms of allergic reactions, including opening airways to the lungs for easier breathing. For those who suffer from severe allergic reactions, the injection can mean life or death.

“This is a lifesaving product,” said Diana Zuckerman, president for the National Center for Health Research; but when considering if things go wrong, she said: “If it fails 105 times, that’s significant.”
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Risk of alarm failure in Accu-Chek Insight insulin pumps could lead to hyperglycaemia

Another issue with insulin devices. These life-saving devices are so important in modern society, so any issue with them is huge.

Diabetics and healthcare providers are urged to check Accu-Chek Insight insulin pump display screens regularly as the alarms on the devices may reportedly fail due to an electrical error. Manufactured by Roche Diabetes Care, the audible alarm and the vibration alarm may not work properly, therefore failing to notify the user of high blood-sugar levels.

A very serious issue indeed.
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Five deaths reportedly involving gastric weight-loss balloons

Regulators report that at least five people have died not long after receiving a gastric balloon fitted into their stomachs to help them lose weight. While authorities have not confirmed that the weight-loss balloons are the final cause of death, all five died within a month of having the Intragastric Balloon System inserted, and three of the patients died between one and three days after the procedure took place.

Given the trend, regulators will need to carefully examine what has happened and whether the cause of death is the devices being used. If it is, action needs to be taken without delay to avoid any further loss of life.
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Medical device alert issued over bi-leaflet mechanical heart valves over risk of inverted implantation

Over the past 15 years, the Medicines and Healthcare product Regulation Agency (MHRA) has been made aware of five incidents where a mechanical bi-leaflet prosthetic valve has been implanted the wrong way round because they were put in the holders upside down. The MHRA is afraid that, due to under-reporting, many more injuries and deaths may have occurred as a result.

The heart controls the blood flow in our bodies and relies on aortic valves to ensure the blood is pushed in the right direction to reach our organs and limbs. However, over time, these valves can become weak or damaged and don’t close properly which can lead to blood leaking back into the heart, making it much harder for the heart to pump it outwards to the rest of our bodies, resulting in heart failure. Artificial mechanical valves can be fitted to replace the weakened or thickened valve.
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Another Medical Device Alert for Intra-Aortic Balloon Pump for a different fault!

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued another medical device alert for intra-aortic balloon pumps, made by Maquet/Getinge. The alert closely follows the one issued over the Datascope Corp’s similar devices that were found to have an electrical fault.

This new alert identifies a “false blood detection alarm and/or fluid ingress” that can also risk failure of therapy to patients. The medical device is used to help the patient’s blood flow, pumping at the same rate as a heartbeat, and is usually used for patients whose hearts may not be strong enough to function alone.
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Medical device alert for Datascope Corp intra-aortic balloon pumps

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for intra-aortic balloon pumps manufactured by Datascope Corp.

Models CS100, CS100i and CS300 are reportedly at risk of “haemodynamic instability to patients with critical care conditions due to a delay in, or sudden interruption of, therapy.”

The medical device cites at least one report of a death involving an allegedly failed CS300 intra-aortic balloon pump. It’s not known how many non-fatal injuries have been caused by the faulty pumps as well.
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NovoPen insulin pens recalled over risk of hyperglycaemia

Certain batches of insulin pens manufactured by Novo Nordisk have been recalled as the cartridge holders may not be strong enough to withstand some household cleaners.

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a medical device alert to notify hospitals and users to return affected batches to Novo Nordisk for replacement.

NovoPen Echo and NovoPen 5 are both affected by the recall. A total of 87 batches in the U.K. have been recalled by way of a field safety notice, citing broken or cracked cartridges as the problem.
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MHRA issues medical alert over Comprehensive Nano Humeral Components

The Medical Health products Regulatory Agency (MHRA) has issued a medical device alert over Zimmer Biomet made Comprehensive Nano Humeral Components over risks of needing revision surgery when used in reverse configuration.

The manufacturer produced a medical device field safety notice earlier in June warning users of the less than accurate labelling on the devices.

The comprehensive ‘nano humeral component’ is usually used in the anatomic or reverse configuration, but after an annual review was conducted, the study data indicated the device was not fit for use in the reverse configuration.
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DePuy Synthes Impactor for PFNA blade recalled over risk of infection

Manufactured by Synthes, the DePuy impactors used for Proximal Femoral Nail Antirotation (PFNA) have been recalled over potentially dangerous risks of infection. PFNA’s are metal devices inserted into the femur bone to strengthen it.

The U.K.’s Medicines and Healthcare Products Regulation Agency (MHRA) has noted a defect with the medical device as a crack in the weld of the handle. The recalled blade is used to insert and position the PFNA in the centre of the bone, and the operating physician uses the handle to grip and position the attached PFNA. It is the handle for the PFNA Blade impactor that can crack, and continued use may mean bodily fluids like blood or bony debris can get inside the device, risking cross-contamination when it’s used for other patients.
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