Opioid Implant Raises Safety Questions

(Editor’s Note: Our story about an opioid implant that could someday be used to treat chronic pain struck a nerve with a lot of readers. One of them was Mary Maston, a pain sufferer and  patient advocate, who wrote in expressing concern about the safety and risks associated with implants and other medical devices.)

By Mary Maston, Guest Columnist

Why is everything going to implants? Implants seem to have an initial success rate and I can't argue with the fact that they do work for some, but it seems that class action lawsuits for side effects and internal injuries invariably come about down the line.

Transvaginal mesh was touted as the "next big thing." I had a doctor try to convince me that it would solve all of my female problems. Luckily, I didn't bite. We all know how that ended up.

Bladder slings come to mind too. Some IUD’s have caused issues. People have had major problems with hip and knee replacements. Spinal cord stimulators are being pushed on patients in record numbers, and the bomb is eventually going to drop on those too.

While there are success stories, there are some pretty horrific stories floating around online about implanted devices in general. Some will argue collateral damage: "Just think of the ones they've helped. The many outweigh the few.”

But I can promise you that the ones that have been harmed by these implants see things much differently.

Here's the thing: anything implanted in the body is going to be seen as a foreign object. What does the body tend to do when there's a foreign object inside it? It attacks it, trying to force it out. That's why your eyes water when you get something in them, that's why you vomit when you ingest something that's harmful, and that's why you go to the bathroom -- so the body can rid itself of waste.

When it can’t force the implants out, the body rebels with side effects, infections and pain. The surgeries required to implant these things damage nerves and create scar tissue, which also contribute to pain.

courtesy titan pharmaceuticals

courtesy titan pharmaceuticals

If they're planning on this new implant being simply injected into the arm instead of being surgically implanted, that's going to have to be one heck of a big needle! The size of a match stick? Ouch!!

Then there is the issue of tolerance. Pain medication is not a "one size fits all" fix like the makers of this implant are implying. It comes with a preloaded dose of buprenorphine. How can they guarantee that the dosage they put in it is going to work for the majority of the people it's implanted in? 

What if it stops working in a month or two, or doesn't work at all? Do they have that one taken out and another one put in, or is the old one left in and a new one with a stronger dose implanted?

Will the patient be able to go back to taking oral pain medication? What if it causes side effects in the patient after a few days or weeks that they can't handle, or they end up being allergic to the medicine? How long would they have to live with those issues before it is removed?

Some people metabolize medications faster than others, so saying that it's going to work for a full six months for the implant or an entire month for the injection in everyone isn't practical. What about breakthrough pain? If someone had the implant, but showed up in the ER in pain because of their condition, would they be treated respectfully and in a timely manner, or dismissed because they had the implant and "that should take care of all of your pain."

There needs to be a very specific and compassionate treatment protocol set up for patients before this scenario happens, and all doctors need to be required to follow it.

I can understand and appreciate some of the pros listed in the article. Not having to make trips to the pharmacy, not having to remember to take pills and waiting for them to kick in to feel better. Possibly and hopefully not having to go to the doctor every month and being subjected to random drug screens and pill counts.

Doctors would certainly benefit because they wouldn't be prescribing pain medications nearly as much or maybe not at all. That would definitely get them off the hook with the DEA and I can see how that would make them want to push it onto all of their patients.

I understand that addiction and chronic pain go hand in hand for some people. Not all, but some. But as a chronic pain patient, I don't want to be lumped into the same category as addicts, because I am not an addict, never have been and never will be.

This raises serious questions that I think should be considered before we shout to the heavens how wonderful this new implant is going to be for addicts and legitimate chronic pain patients alike.

I understand there is still a lot of work to be done, and that it's going to take time and testing to answer a lot of these questions. Oral medications certainly have their own set of problems and aren't without risks either. However, history tells us that jumping on a bandwagon isn't necessarily a good thing down the road in a lot of cases.

I'm not saying that the thought of being pain free for an extended amount of time isn't appealing. Honestly, I would probably be more apt to try this than a spinal cord stimulator. But I hope that the manufacturers and the FDA will address the questions I've posed. I guarantee you I'm not the only one that will ask them.

Mary Maston suffers from a rare congenital kidney disease called Medullary Sponge Kidney (MSK), along with Renal Tubular Acidosis (RTA) and chronic cystitis. She is an advocate for MSK and other chronic pain patients, and helps administer a Facebook support group for MSK patients.

Mary has contributed articles to various online media, including Kidney Stoners, and is an affiliate member of PROMPT (Professionals for Rational Opioid Monitoring & Pharmaco-Therapy).

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.