5 of the faulty devices . . .
THEY were meant to revolutionise medicine. And thousands of NHS patients have, unquestionably, benefited from manmade implants. But some devices have caused problems for thousands of patients . . .
CONTRACEPTIVE IMPLANT
ESSURE, a small spring-like implant made from tough titanium, was developed 15 years ago and was meant to be a drugfree alternative form of contraception for women.
It works by blocking eggs from moving out of the fallopian tubes and into the womb. The device, inserted via the vagina, works by triggering the formation of scar tissue in the fallopian tubes.
The big attraction was it didn’t involve surgery; the whole procedure took just 15 minutes.
But Essure was withdrawn by the manufacturer last year after claims some women suffered problems such as chronic pelvic pain and ectopic pregnancies.
A U.S. study, published in the British Medical Journal in 2015, found women with the implant were ten times more likely to need follow-up surgery to correct problems than if they had conventional sterilisation.
However, the numbers were still small — just over two per cent needed surgery, compared with 0.2 per cent in the other group.
HIGH-TECH PACEMAKERS
AROUND 35,000 people a year in the UK have a pacemaker fitted.
In 2015, a device called Nanostim was withdrawn because nearly one in 20 patients suffered a build-up of fluid that, untreated, can cause a life-threatening drop in blood flow to vital organs. A study in the latest Journal of Interventional Cardiology and Electrophysiology found more than one in 20 out of 1,439 patients fitted with a Nanostim suffered serious adverse effects within the first 30 days.
The implant was turned down by safety bodies in Germany due to lack of evidence but given the green light by the British Standards Institution in the UK.
INCONTINENCE MESH
ARGUABLY the scandal that brought implant concerns to a peak, vaginal mesh, is thought to have maimed thousands of women in the UK.
The material was widely used to tackle stress urinary incontinence. But while successful in many women, in some the plastic mesh started to disintegrate, causing extreme pain.
The Medicines and Healthcare Products Regulatory Agency (the MHRA) says between 1 and 3 per cent of women suffer adverse effects. But a study by Case Western Reserve University in the U.S. suggested the figure was actually over 40 per cent.
In July, officials in the UK announced it could no longer be used unless a list of strict conditions have been met.
BREAST IMPLANTS
ONE of the biggest implant scandals was the use of industrialgrade silicone for human breast implants. So-called PIP implants were made from silicone gel which ruptured, causing pain and swelling. They were withdrawn in the UK in 2010, but an estimated 47,000 women had them implanted. The MHRA advises women not to have them removed unless they are causing problems.
HIP REPLACEMENTS
IN 2004, a new type of man-made replacement hip joint was introduced in the UK. The joints were made from bare metal and were meant to have lower failure rates than other joints available.
Around 12,000 people had the metal-on-metal joints implanted. But in some, the joints began to wear out quickly — causing damage in the bone around the hip.
Research revealed that the number of patients who needed repeat surgery because their artificial hips had failed were higher in metal-on-metal joints.
In 2013, U.S. manufacturer DePuy (part of Johnson & Johnson) pulled the Pinnacle Ultamet from the market, blaming poor uptake by surgeons.