What Can A Patient Do To Address Safety Issues of Medical Implants?

A global investigation called ImplantFiles found an absence of clear guidelines on testing,  poor regulatory practices and lack of transparency resulting in pain to patients and in some cases even untimely death. As the medical device industry innovates at a rapid pace and flaws found in devices trigger recalls and safety alerts, Dr. Shital Raval looks at what the patient can do to reduce the risk.

How safe are the medical devices implanted into your body? Did you know that medical implants in India are often found to be faulty or rejected products from other parts of the World? In fact, as per the latest investigative reports, more than half of the medical equipment and diagnostic machines were recently found to be secondhand and used without the consent of the patient.

So what are medical devices? A medical device is any material, apparatus, implant, machine, instrument or software that is used for the purposes of diagnosis, prevention, treatment, monitoring or alleviation of a disease or condition. Under this broad category, devices can include simple bandages, glucometers, to diagnostic scanning equipment, monitors, catheters, syringes, etc. and a vast range of implants. Implantable medical devices include stents, pacemakers, intrauterine devices (IUDs), intraocular lens, cochlear implants, insulin pumps, prostheses such as knee, breast, dental, hip implants etc. 

A series of journalistic investigation in recent months, have revealed negligent practices about medical devices that are being sold in India. The articles reveal a sheer lack of regulation, ownership and standardization of devices that are inserted into patient’s bodies.  

An implant is inserted when a patient requires mechanical support, direct delivery of medication or replacement of a body part. Orthopedic knee and hip replacements are growing to be the most common implant surgeries close after stents in Cardiology. As the demand for implants grows, the black market for them has unfortunately also increased. Since there is no law that requires testing of all the medical products, there is no quality control mechanism in place.

Faulty hip implants gained lots of attention after the 2018 Johnson & Johnson case where not only were defective ASR hip implants allowed in India after being recalled worldwide in 2010, but even recall of the product was delayed and  inefficiently carried out. The ASR hip had been inserted in about 4700 patients in India. Patients were then left struggling with revision surgeries along with prolonged court cases against a multinational to obtain any settlement or a decent compensation. 

Dr Ravi Mohanka, a Liver Transplant Surgeon from Global hospital in Mumbai echoes our concern about the current opacity in the usage of medical devices. He tells us, “There is a huge discrepancy in the equipment being used in private vs local hospitals and clinics. Even though using only disposables may not be an affordable option for the healthcare system in India, doctors must have a discussion about new or secondhand devices so that patients can make their own decision, especially when cost is a decision-making factor. Our system needs to be more transparent! The burden of responsibility also lies on hospitals and medical doctors who can make their patients more aware and informed”. 

So what can we do as consumers of these ever increasing medical implant usages that are almost unavoidable?  While we continue to seek a stronger regulatory framework for devices and implants as well as greater transparency in information being passed on from our doctors, being a aware  self-and knowledgeable patient is the best way to avoid and address grievances and reduce mental anguish.

A few steps that the patient can take before undergoing any surgery which requires an implant:

• Always take a second opinion before going into any surgery. In many cases such as knee replacements, it has been found that physiotherapy, diet and exercise can help avoid surgery all together.
• Do your homework before your doctor’s appointment so you are aware of treatment options and can ask your doctor about what may be the best choice for you. 
• Find out if your doctor has the capability to insert devices of the other manufacturers. This will provide you a fair idea about his expertise and bias towards any single company.
• Get details about what implant you will be inserted with such as name, make, model etc. 
• Inquire about feedback on patients who have already been inserted with the same implant. Doctors should be able to provide you with their contact so you can reach out to them. Certain doctors are now routinely creating telephonic or online support groups with their patients for easy access and communication. 
• Research the company that makes the device you have been suggested. Compare with other devices in the market.
• Search for discussion forums online for patient reviews.

Once you have decided to go through the surgery for a mutually sought upon implant, what else do you need to know?

Here are some questions that you should be asking your surgeon leading up to your procedure.

• What will be the post-operation rehabilitation?
• What are side-effects of this procedure and implant?
• What adverse events should I look out for? 
• Is this device MRI compatible? If no, what happens in the event of an accident or health issue?
• Does this device have an expiration date? What is it? 
• If a new or updated version of this device becomes available, will I be eligible for that?
• Is there a patient and/or doctor database for this medical device?
• If there is any problem with my implant, who should I contact? How is a complaint filed?
• If there is a recall of this product, who will notify me?

A medical product recall is when a device is detected to have a problem or requires adjustment i.e removal or correction. Currently there is no fixed protocol on product recall by the Central Drug Standards Controller Organization (CDSCO), which is the Indian regulatory board for drugs.  The absence of any monitoring body to check on device performance and adverse events is a critical patient safety concern. For instance, in the US, if there is a recall by the manufacturer, the FDA is alerted and correct removal action is taken by updating the Medical Device Recall Database, issuing public notices, press releases etc. Last year, a certain manufacturer had recalled its insulin pump in India but failed to notify the patients. It only came into light after endocrinologists noticed the news of recall and informed their patients. 

A proactive approach towards your disease and medical treatment is the best step in the direction of self-care vigilance. Patient empowerment is slowly becoming the way forward as the patient-doctor relationship is re-shaped. This becomes the fundamental basis for ensuring that you as a patient are making informed decisions about your body.

References

1. Sarin, Ritu and International Consortium of Investigative Journalists (ICIJ). “Implant Files” Indian Express, 2018. 
2. Global Investigation Implant Files 
3. The Medical Device Regulation (MDR) 2017/745.  
4. Wu, Brian. “3 reasons why patient empowerment is growing in healthcare”. March 30, 2017. 
5. “Do we need powerful Law on Medical devices in India?”  Newsclick Report. Dec 4, 2018. 
6. U.S. Food & Drug Administration List of Medical device Recalls. 

If you have an experience to share write in to us