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Medical devices – is it time for a proper register?

Medical devices are helping many of us live longer and enjoy a better quality life as we get older.  This has led to a growth in the use of medically implantable products such as hip replacements, knee replacements, vaginal mesh and other products.  It is anticipated that by 2024 the global market for implantable medical devices will be worth almost fifty billion US dollars.

With this new and expanding market, it is likely that there will be ‘teething troubles’ with new products.  Unlike household products like washing machines when medical products break they can have serious consequences for the patient.

Corries are specialist product liability solicitors. We can help you if you have been affected by a dodgy medical product. Call us FREE on 0800 655 6550 NOW.

We ask how many are affected by these products – and what can be done to make sure dangerous medical products are not on the market?

medical device register

medical devices should all be on a register

THE NATIONAL JOINT REGISTRY

 The current guidelines published by the National Institute for Clinical Excellence (NICE) state that a hip replacement should last an average of ten years for ninety-five per cent of patients.  In the mid-1990s the orthopaedic world was rocked by the 3M Health Care hip joint replacement scandal.  It was said that these joints were introduced without proper testing and caused the joints to loosen. This led to patients undergoing further revision surgery within as little as 18 months. The article is here for you to see

Following the 3M disaster the Department of Health recognised a need to monitor joint replacements to ensure nothing like this happened again.  The National Joint Registry (NJR) of England and Wales was founded in 2002 and over time expanded to include Northern Ireland (2013) and the Isle of Man (2015).  The NJR compiles data for hip, knee, ankle, elbow and shoulder joint replacements.  The goals are to monitor by brand, hospital and surgeon each joint replacement and to help investigation and action where figures fall below those expected.  The NJR allows for the collection of good quality data.

Medical Devices – Hips

Information obtained and published by the NJR has helped improve quality and altered surgical techniques and use of prostheses.  In 2010 DePuy International Limited voluntarily recalled their ASR hip system which they themselves attribute to the information in the NJR, They commented at the time

“….after receiving new, then-unpublished data from a joint replacement registry in the UK. This 2010 data indicated that while most patients with the ASR Hip System had not required additional hip surgery, the rate of ASR patients who needed a second surgery, called a revision surgery, was not in line with data previously reported in that registry.”

Medical Devices – Vaginal Mesh

Vaginal mesh has been used to treat stress incontinence which can lead to women, especially after childbirth, leaking urine from their bladder.  In order to help prevent the bladder leaking, the mesh is implanted to provide support to or strengthen weak organs and damaged tissues.  The product was used worldwide from the early 2000’s for stress incontinence and hernias.  It was then expanded for use with prolapses in the mid-2000’s.  At this point little or no further testing was carried out to ensure that the product was suitable for use with prolapses. An article commenting on this can be found right here

In recent years a picture has emerged of problems with this commonly used vaginal mesh.  In 2014 the UK government estimated that at it’s peak around 3000 mesh products were sold annually in the UK.  Statistics quoted in the Guardian show a survey of 2,220 women undergoing pelvic mesh implant of which 59% stated that the mesh did not resolve their stress incontinence and 58% stated that they had pain during sexual intercourse. About seventeen years later, in December 2017 NICE guidelines stated that mesh can still be used for stress incontinence and hernia repairs (in men and women).  Mesh repair for pelvic organ prolapse should only be used for research purposes.

It is very worrying to note the different timescales with the two products.  The ASR hip system was used from around 2003 up to recall in 2010.  The vaginal mesh on the other hand was used for a much longer time period, at least seventeen years before the NICE guidelines were amended.  What is the difference?  Here at Corries Solicitors we would argue the difference in the two scenarios is the data collected by the National Joint Registry.  The data was collected about the ASR hip but not about mesh.

Medical devices – Essure

Essure is a form of permanent birth control, confusingly it is often referred to as a coil but is in fact something completely different to a hormone coil. This Essure implant is in fact a form of female sterilisation.

Essure is inserted via the cervix into each fallopian tube. It looks like a coiled spring, it does not contain hormones but is made from materials including polyester fibres, nickel, titanium, platinum, silver-tin and stainless steel. This procedure was an alternative to laparoscopic sterilisation using clips i.e. what is commonly known as ‘having your tubes tied’ and is an invasive surgical procedure.

In the months following the implantation of the Essure device, the body reacts and forms scar tissue around the implant. Thereafter, the fallopian tube becomes blocked which prevents eggs being fertilised by sperm. According to the manufacturers of Essure, the formation of scar tissue typically takes three months but can take anything up to six months. This procedure is an irreversible form of contraception.

Although available from the early-2000’s, this product was not recommended for use in the UK by NICE until 2009.  There have been reports of women suffering many side effects from Essure such as unbearable pain, cramps, damaged internal organs, infections and the requirement for a hysterectomy to relieve the symptoms. The Daily mail have picked up on the scandal in an article published today right here

For any product to be sold in Europe it must have a CE (commonly called Kite) mark.  In August 2017, the CE mark for Essure was not renewed.  On this basis, NICE no longer endorse the use of Essure.

Essure was used in England and Wales from 2009 to 2017.  Would side effects have been picked up sooner if there been a registry for all implantable medical products not just joints?

medical devices

Corries are calling for a full register for all medical devices

Time for change?

 The value of the National Joint Registry (NJR) has been established.  Corries strongly support the need for the NJR to be extended to ALL implantable medical products.  In a recent debate in the House of Commons regarding mesh, this view was echoed by the Labour MP, Carolyn Harris for Swansea East who said:

The NHS tells us that insufficient reporting and under-published data are contributing to the problem. A basic requirement should be a register of women who have had the implants, so that we can truly assess the potential impact”.

At Corries we believe there should be a requirement for all implantable medical devices to be recorded in a register. These requirements should be the same for all medical products such as a pacemakers, artificial joints, breast implants, contraceptive devices,coronary stents or intraocular lens.  Statistics should be recorded per make and model or device, by surgeon and by hospital.  This would make it easier to find patterns and problems earlier and get defective products off the market or suspended until safety is investigated. This would mean less people will be affected and fewer lives ruined.

Whatever your health problem, whatever the product implanted all patients require the same level of protection. The costs of extending the NJR should not be huge – and surely the price of saving misery and suffering is worth it?

Corries are specialist product liability solicitors. Has you health been affected by a medical product. Call us FREE on 0800 655 6550 for a FREE no obligation chat.