Patients have suffered “debilitating consequences” from medical implants that doctors had assured them would be safe, the government has said in a significant acknowledgement of failings with medical device regulation. The health and social care minister, Jackie Doyle-Price, said commercial interests had been prioritised over patient safety, with other problems including a lack of transparency…
Patients have suffered “debilitating consequences” from medical implants that doctors had assured them would be safe, the government has said in a significant acknowledgement of failings with medical device regulation.
The health and social care minister, Jackie Doyle-Price, said commercial interests had been prioritised over patient safety, with other problems including a lack of transparency and doctors’ failure to warn patients of risks.
“It is fair to say that perhaps in the past regulation has focused excessively on what is in the commercial interests of businesses to maintain competition, rather than having patient safety at its heart,” Doyle-Price told a parliamentary debate on Tuesday evening. “It has not always been easy for patients to investigate and find more data about the things being put in their bodies.”
The debate, secured by Owen Smith, the Labour MP for Pontypridd, followedan investigation into the medical implants industryby the Guardian and other media organisations coordinated by the International Consortium of Investigative Journalists (ICIJ). Smith said patients had been harmed by implants including vaginal mesh, metal-on-metal hips, breast implants and faulty pacemakers, because of serious underlying problems with the way such devices are approved for clinical use.
Doyle-Price said the government was looking at establishing a national medical devices registry that would make all implants traceable and alert regulators to problems once devices were approved for clinical use.
“This matter is already under consideration … and it is linked to our wider digitisation agenda for theNHS,” she said. “We have the technology and we should use it in the interests of patient safety.”
Smith cited figures uncovered by the Guardian’s investigation, which revealed that UK regulators had received reports of 64,000 adverse events involving medical devices between 2015 and 2018, a third resulting in serious medical repercussions and 1,004 in death.
“There are devices on the market here and across the world that are still causing grave medical problems for patients,” he said.
Smith said problems included the failure to conduct clinical trials for a remarkable proportion of devices on the market, that manufacturers were in charge of testing their own products after faults developed and that they were allowed to shop around for approval to market their products without declaring any refusals.
The problematic relationship between doctors and companies was also highlighted. “Some [doctors’] have an interest in those companies, and others are getting a money benefit through doing this in the private sector,” he said.
Doyle-Price said of vaginal mesh, which can now only be used in highly restricted circumstances, that far too many women had been given the surgery and urged those who had suffered problems to pursue medical negligence claims against doctors.
Doyle-Price had previously said the benefits of vaginal mesh surgery outweighed the risks andhad rejected calls for an inquiry.
Rules making it tougher for devices to get approval are due to be introduced inEuropein 2020. Doyle-Price said the government remained committed to adopting the new regulations, including in the case of a no-deal Brexit.