The Implant Files is a globe-spanning investigation revealing a broken system that allows flawed medical devices to go onto the market — and into our bodies. Involving more than 250 reporters in 36 countries, ICIJ reporters and partners with hundreds of patients about the system’s pitfalls.
There are countless medical implant success stories to celebrate. But the public is often the last to know about potentially dangerous malfunctions tied to implants. We hope that this resource will arm readers with information that makes informed decisions about medical devices easier.
We will add to this resource whenever necessary. If you think we’ve missed something, or have erred in any way, we welcome your feedback. Please send it to Amy Wilson-Chapman, ICIJ’s community engagement editor: firstname.lastname@example.org
Medical devices have helped to diagnose, prevent and treat various injuries and diseases. This resource is not intended to provide medical advice, and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.
Special thanks to the following professionals who contributed to this resource: Dr. Anand Deva, a cosmetic and plastic surgeon from Macquarie University in Australia; Dr. Carl Heneghan, professor of evidence-based medicine at Oxford University in London; Diana Zuckerman, president of the National Center for Health Research in the U.S.; Dr. Hanifa Koya, gynecologist at Wakefield Hospital in Wellington, New Zealand, Jeanne Lenzer, U.S. based author of The Danger Within Us; Angie Firmalino, president of Advocating Safety in Healthcare, E-Sisters, and Madris Tomes, founder and chief executive of U.S. based Device Events.
What is an implant?
An implant is a medical device that is put inside or on the surface of the body. Implants may replace body parts, such as hips; deliver medication; monitor body functions; or support organs and tissues.
ICIJ and partners decided to call this investigation the Implant Files because we focused our attention on these implantable medical devices. This refers to a medical device that goes under the skin or inside the body.
What is a medical device?
There’s no simple answer, and different countries have different definitions. It’s a broad category that ranges from tongue depressors and elastic bandages to pumps for pain or insulin, some types of birth control, robotic surgery equipment and sophisticated heart pacemakers. Medical devices can be used to diagnose, prevent, monitor, treat or alleviate disease or injury but can also replace, modify or support various parts of bodies, such as knees or hips. They can support, sustain and improve life.
What the category doesn’t include is drugs, which have to meet a stricter set of regulations.
For a more detailed explanation here is how World Health Organization defines a medical device.
Do all medical devices have problems?
No. For example, pacemakers and implantable cardioverter defibrillators (ICDs) have revitalized and saved millions of lives. Hip and knee replacements have kept tens of millions of people mobile and out of wheelchairs. Intraocular lenses have restored and improved the sight of millions more.
At the same time, devices sometimes malfunction, often with gruesome consequences. Our analysis identified more than 1.7 million injuries and nearly 83,000 deaths potentially linked to devices reported to U.S. regulators over a 10-year period. This count was not definitive, as not all malfunctions, deaths and injuries are reported.
I found my device in your database. What should I do now?
Do not assume there is a problem with your device because you found it in the International Medical Device Database (IMDD). If you are concerned, you should contact the surgeon who performed your operation or your primary care doctor.
The IMDD is a collection of recalls, safety alerts and safety notices from 11 countries. Less than 20 percent of the world’s countries report data on devices to the public, including whether devices have been recalled.
What should I ask my doctor if she suggests I get an implant?
You should treat this like any surgery: weigh your options and understand what the surgery entails. Three good questions, suggested by Angie Firmalino, president of Advocating Safety in Healthcare, E-Sisters, to ask your doctor, before deciding to go ahead are:
How many of these medical procedures have you done?
Have any of your patients had problems with this device? If yes, what were they? Have you been able to remove the device if something went wrong? What is the removal protocol? Remember, you can always get a second (or a third) opinion.
I am considering getting a device. What should I research?
The more informed you can be about a medical device, the better. Some good questions to get you started include:
Who has studied the device? Has it been tested in scientific studies?
What are the long-term effects of the device? (Look at the number of people it was tested on and how long their effects were monitored.)
How long has the device been on the market?
Is there an alternative?
Can the device be removed if something goes wrong?
Has the device been recalled? (You can use our International Medical Device Database to search for this, as well as your local regulator — see below. Even if you live outside the U.S., the U.S. Food and Drug Administration’s website can often be a valuable resource.)
I have an implant, and I’m worried there is a problem. What should I do?
Your first point of call should be the medical team that performed the operation. If you cannot go back to them for whatever reason, you should consult your primary care doctor. The doctor should be able to refer you to a specialist who is familiar with the device and the surgery you had.
My medical device is having a negative effect on my health. How do I report it?
If you live in the U.S., the FDA relies on the voluntary reporting of problems by patients, as well as mandatory reports by manufacturers. To submit a report, go to the FDA’s website. There is a helpful guide on how to make a report.
Outside of the U.S., you should contact your local regulator (the Therapeutic Goods Administration in Australia, or the Medicines and Healthcare products Regulatory Agency, for example) and ask the regulator how to report the negative effect.
Not sure who oversees medical devices in your country? Use the World Health Organization’s Global Atlas of medical devices to find out.
How do I know if my device has been recalled?
Search the International Medical Device Database to see if the device has been recalled. Remember that this database does not contain information from every country. To find out which countries it includes, check here. Even if your country is not listed, you might be able to see if the device in question was distributed there at some point.
If you want country-specific information, you should contact your local regulator using WHO’s medical device atlas. We have provided a list of agencies below as well. The FDA’s website contains a lot of information about specific devices, but remember it is U.S. focused.
How do I know if an implant is safe?
Research and information is the only way to know if an implant is safe. It’s crucial to do your own independent research. If there are clinical studies, consider their extent: how many patients did they follow? For how long? How were people affected by the side effects of the device?
How did that change over a longer period of time?
Make sure you understand the side effects of the implant and how they may change over time. Does it get worse or better? Discuss all information with your doctor (as well as trusted friends and family) and seek out people who have had the same implant to find out about their experience.
If something goes wrong, I can just get the device removed, right?
Not necessarily. Do not assume an implanted device can be removed. There are many cases when removing a faulty implant is more dangerous than leaving it in. That makes it important to ask when you are considering an implant: how will this be removed, or undone, if something goes wrong?
How do I know if my doctor or surgeon has a stake in the medical device they are urging me to use?
If you’re in the U.S., you can search for your doctor in the Center for Medicare & Medicaid Payments database. This database includes payments that include speaking, consulting, meals, travel and royalties to medical doctors, dentists, osteopaths, optometrists, podiatrists and chiropractors.
What is the CE mark?
‘CE’ stands for “Conformité Européenne. This is the identifying logo on packaging or instructions included with a range of products – including medical devices, toasters, children’s toys and fireworks. It means the products meet “high safety, health and environmental protection requirements.
I am thinking about getting a breast implant, where can I find the more information?
There are several websites for women considering breast implants.
Saferbreastimplants.org offers a list of surgeons (mainly based in the United States, Australian and New Zealand) who have pledged to adopt a sterile technique The U.S.-based think tank, the National Center for Health Research, has an FAQ specifically for breast implants. It also offers a comprehensive list of What You Need to Know About Breast Implants that addresses a range of risks. The National Center for Health Research also suggests you consider these nine points beforehand.
I think I have one of the metal-on-metal hips featured in your reporting. What should I do now?
If you have any concerns, you should contact the orthopedic surgeon who performed your surgery. The FDA suggests that anyone who has “hip/groin pain, noise, difficulty walking or a worsening of your previous symptoms” should contact the orthopedic surgeon right away. For more information, please consult your doctor, or you can read the FDA’s advice on the topic.