Medical Devices and Safety

By Sue Claridge

First published in the February 2019 edition of the Auckland Women’s Health Council Newsletter

Why aren’t medical devices regulated like drugs?

One of the British Medical Journal’s editors, Fiona Godlee, asked this very pertinent question and reported that “a major international investigation, involving 59 organisations and including the BMJ, finds device regulation unfit to protect patients from harm.”

Surgical mesh has had a lot of publicity of late – both nationally and internationally – and deservedly so, but mesh is only one of many medical devices unleashed upon a largely unsuspecting public only for things to go very badly wrong for many patients.

Ms Godlee asks BMJ readers, who are predominantly practicing doctors and physicians, “How much do you know about the safety and effectiveness of the implanted devices your patients are offered? You may assume that pacemakers, neurostimulators, joint prostheses, and breast implants have been tested rigorously before being licensed for widespread use.”

Sadly, and at times catastrophically, that is not the case. Volume 363 of the BMJ, published in the last week of November 2018, features four articles on medical devices and the international investigation into their safety:

• How lobbying blocked European safety checks for dangerous medical implants (www.bmj.com/content/363/bmj.k4999)
• Surgeons call for compulsory registers of all new medical devices (www.bmj.com/content/363/bmj.k5010)
• What happens when the world’s biggest medical device maker becomes a “health services provider”? (bmj.com/content/363/bmj.k4917)
• FDA recommends “modernizing” review of devices in wake of global investigation (www.bmj.com/content/363/bmj.k5026)

In Europe, the investigation, which involved 250 journalists and 8 million device related health records, found that “sources of harm to patients include a lung sealant that leaked, breast implants that went rancid, implanted pacemakers that stopped working, and deep brain stimulators that had to be removed.”

The website Implant Files (www.icij.org/investigations/implant-files/) is devoted to the first-ever global examination of the medical device industry investigation, which has found that health authorities across the globe have failed to protect millions of patients from poorly tested implants.

The investigation found that when flaws are found in medical devices and safety alerts and recalls are triggered, all too often these warnings fail to reach doctors and patients. Recalls, withdrawals and bans on devices are not uniformly applied from country to country causing confusion and raising risks to patients where insufficient action is taken.

Surgical mesh is specifically mentioned as an example of how variable the response to problems with devices is, “even when devices have received intense public scrutiny.”

“Sales of a controversial variety of pelvic mesh device for organ prolapse repair and incontinence treatment, for instance, were halted over the last year by authorities in New Zealand*, Ireland, Scotland and England — but sales continued in other countries, including Canada and South Africa.”

Another device that we have covered, Essure, is mentioned in the Implant Files:

“Despite years of outcry from patient advocates, the controversial Essure birth control device remains on the market in the US until the end of 2018, more than a year after its removal from other markets around the world. Despite being removed from these markets, you won’t find much trace of the product in ICIJ’s Medical Device Database because its maker, Bayer, maintains that it removed it from countries around the world for business reasons, not safety concerns.” [our emphasis]

Hip implants, pacemakers and defibrillators, breast implants… the list seems to go on and on. Despite New Zealand being one of the countries mentioned with “established national or regional device registries” we don’t have registries for all devices. Mesh Down Under have been pushing for a mesh registry for some time and we still don’t have one, and when we investigated the use of Essure in New Zealand in early 2018 it was clear that there was no centralised record of who had the device implanted or even how many women there were with the device, let alone any registry of problems or adverse reactions reported.

The Implant Files investigation found that the medical devices industry has massive financial resources and broad influence allowing it to spend “hundreds of millions of dollars developing close relationships with doctors and hospitals and on lobbying governments for deregulation, easier approval systems for new devices, and more.” In 2017, device manufacturers “made payments to doctors and teaching hospitals for research, travel, royalties, consulting fees and more,” and that in the US the average time for a new device to be approved has dropped by more than 200 days in the last 20 years. Faster approval goes hand in hand with minimal testing and a 2016 study in BMJ found that devices approved first in the EU were associated with a higher rate of safety alerts and recalls than those approved in the US.”

While the Implant Files make chilling reading, the key findings of the study are particularly galling, and the final finding confirms what many of us already knew – that women bear the brunt of the greed of manufacturers and incompetence of regulators and governments:

• Medical devices improve and save lives, but governments have allowed products on the market with little or no human testing that went on to cause great harm.
• Devices pulled off the market in some countries over safety concerns remain for sale in others.
• The device industry, and the regulators that oversee it struggle to quickly identify hazardous implants after they are released, leaving patients exposed.
• Manufacturers, doctors, and others potentially linked more than 1.7 million injuries and nearly 83,000 deaths to medical devices in reports to US regulators over the last decade.
• Some of the highest-profile controversies in recent years involve products marketed to women, including contraceptive coils, vaginal mesh, and breast implants.

The results of this international investigation should be required reading for our health agencies and policy makers. Policy makers and regulatory agencies in New Zealand it is time you sat up, took notice and protected patients from harm.

* Even now, those fighting for action over surgical mesh in New Zealand believe that the action taken here is insufficient to adequately protect patients, as has been discussed on several occasions in the AWHC Newsletter and on our website.