Category: Medical
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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Class 2 recall for Diclo-SR 75 pain-relief tablets
A Watford-based pharmaceutical company has issued a voluntary recall for batches of Diclo-SR 75 pain relief tablets – AKA diclofenac sodium.
The tablets are commonly used for pain relief and swelling for arthritis, musculoskeletal disorders, gout and pain caused by injury or minor surgery. The tablets are classified in a group of medicines called non-steroidal anti-inflammatory drugs.
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Regulators issue urgent recall over “toxic” spinal fusion stimulators
Regulators have issued a top-level recall over Zimmer Biomet SpF spinal fusion stimulators amidst concerns that the medical devices contain chemicals that can seriously harm patients, and even be fatal.
This is a serious recall given there is a reasonable probability that using a certain defective product can serious injure or kill the patient. It’s reported that 33 affected units were manufactured and distributed.
The affected stimulators are the SpF-XL IIB (22 units) and the SpF- Plus (11 units)
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Alvogen recalls 24 lots of hypertension drug off the market due to chemical contamination
A medical drug manufacturer has initiated a voluntary recall on 3rd July 2017 after concerns their Nifedipine tablets have become contaminated with other medication ingredients.
The company, based in Iceland, makes the hypertension drug under the brand name Adalat, which is supplied to Bayer HeathCare. It’s used for channel blocking and as treatment for hypertension (high blood pressure).
The recall was initiated after a potential cross-contamination between the Nifedipine and another drug in the same facility.
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MHRA issues a medical device failure alert as all HeartStart MRx defibrillators might not deliver lifesaving shocks
According to our Medicines and Healthcare products Regulatory Agency (MHRA), certain defibrillators may fail to deliver controlled shocks, cardioversion, pacing or monitoring.
The HeartStart MRx defibrillators are manufactured by Philips Healthcare and it’s believed the fault lies with the batteries. The lifesaving medical devices could fail to turn on or reboot themselves repetitively, therefore hindering administrators from being able to deliver shocks. The device could also “fail to deliver a shock or undertake pacing” after it has been unplugged from AC mains.
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MoM hip replacements potentially causing long-lasting injuries
All Metal-on-Metal (MoM) hip replacement patients are being recalled for advice and investigation in the U.K. The Medicines and Healthcare products Regulatory Agency (MHRA) has recently issued an updated medical device alert on 29th June 2017.
It’s estimated that 49,000 patients in the U.K. were given the MoM implants (with width of 36mm or above). The NHS notes that around 3,387 surgeries in 2010 used the 36mm (or above) MoM implants.
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Rogue surgeon who performed unnecessary mastectomies on patients jailed
“Monster” surgeon jailed for 15 years.
Former breast surgeon Ian Paterson has been jailed for 15 years after he was found guilty of unnecessary mastectomies to several patients, and was convicted of multiple counts of wounding with intent.
This is a unique case – we hope victims will find some comfort in this decision, although we know the lifelong effects of his criminal activity may never be repairable.
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DePuy Synthes elbow implants recalled by the MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a recall for radial head elbow artificial replacements amidst concerns over post-operative loosening of the device.
Manufactured by DePuy company Synthes, the implants are suspected to loosen at the stem of the implant where it joins the bone. The Straight Radial Stem and the Curved Radial Stem implants are both affected by the recall. The recall follows on from a Field Safety Notice (FSN) issued back in December 2016 by the company’s Senior Quality Assurance Manager, Anne Brisson.
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Philips Respironics V60 ventilator medical devices recalled
The Medicines and Healthcare products Regulatory Agency (MHRA) recently initiated a medical device alert as a result of Philips Respironics’ faulty software that could lead to a sporadic shutdown of the medical device.
The Respironics V60 ventilator’s are used in hospitals to assist in patient ventilation. Recently the medical manufacturer issued a Field Safety Notice (FSN) to notify users of the risk.
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MHRA publishes a class 2 Medicines recall for Sodium Cromoglicate eye drops
The Medicines and Health products Regulation Agency (MHRA) published a medical drug alert on the 18th May 2017 issuing a precautionary recall for bottles of eye drops amidst concerns that the solution can solidify in its container.
Sodium Cromoglicate solution eye drops are typically used to treat red, watery and itchy eyes. Common users are allergy suffers who react adversely to animal hairs, dust or pollen. Marketed as anti-inflammatory, it’s a remedy to alleviate itching and prevent damage to the eyes and delicate surrounding skin by rubbing. The eye drops are also used by contact lens wearers too.
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Issues with battery life of the Accu-Chek Insight insulin pumps
All Accu-Chek Insight insulin pumps have received new instructions for better device management due to previous complaints about the battery lifetime and the device having unexpected shutdowns.
The first warning for the medical device was issued on the 4th August 2015 where Roche Diabetes Care, the medical manufacturers of the insulin pump, issued advice about the correct battery specifications and appropriate pump settings.
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BD Plastipak 100ml catheter tip syringes with Luer slip adapters have been recalled after fears of leakage
The government’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert and announced the recall for reportedly defective plastic syringes.
Manufactured by Becton Dickinson, the catheter tip syringe with Luer slip adapters have reportedly failed routine stability tests. Under testing, the syringes can leak through the syringe stopper, rendering administration of medicine inaccurate and unsafe.
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