The Risks of the Inspire Implant: How I Counsel My Patients

First, the big picture

Inspire is, by the standards of surgery for sleep apnea, a remarkably safe procedure. In the pivotal STAR trial, serious procedure-related events occurred in fewer than 2% of patients in the first year,^[5] and the large post-approval ADHERE registry reported similarly low rates of serious events.^[7] In my own research comparing Inspire directly against traditional sleep surgery across matched patients from a national health-records network, the difference was striking:^[11]

From my 2022 study of a ~70-million-patient records network; the comparison against multilevel sleep surgery was similar (3% vs 21% complications).^[11] A separate study I co-authored found 30-day return-to-operating-room rates of 0.1% for Inspire vs 4.8% for traditional airway surgery.^[12]

Transparency: I consult for Inspire Medical Systems — a relationship disclosed in those studies as well. Full disclosures are on my About page.

“Safer than the alternatives” is not the same as “risk-free,” though. Here is the actual conversation I have with every patient.

Bleeding

Bleeding can happen after any surgery. Here it can present as a hematoma — a lump of clotted blood under the skin. It can happen at either site, but in my experience it almost always happens at the chest, and would be rare in the neck. Sometimes it’s just more bruising than expected; other times it’s a lump, and at times quite a large one. When I’ve seen this, it has always been at the chest site. In my experience, this happens about 1% of the time.

The main thing that makes bleeding more likely is blood-thinning medication — common things like aspirin, Plavix, Eliquis, and Coumadin. These are typically held before surgery, but never stop them on your own: how long each one needs to be held differs by medication, and the decision has to be coordinated with your surgeon and the doctor who prescribed it. It may be reasonable to continue low-dose aspirin through the procedure, since the bleeding risk with low-dose aspirin alone may be minimal — but again, that’s a conversation for you and your physician. The other thing that puts people at risk is not following the activity restrictions after surgery — resuming activity too soon may raise your risk of bleeding.

If excessive bruising or a small, non-growing hematoma forms, most often nothing needs to be done. Your body will absorb the clot over time, and you’ll heal completely normally.

Infection

Thankfully, the risk of infection with Inspire is low — but when it happens, the consequences can be severe. Nationally, the calculated incidence works out to roughly half a percent.^[9] I published my own center’s numbers, and I’ll be candid about them: infection occurred in 3 of 215 patients (1.4%) — and all three ultimately required removal of the device.^[4] That is exactly why I do everything in my power to prevent it. Your surgeon may or may not choose these same measures, but it could be worth a conversation:

• A staph/MRSA decolonization protocol before surgery — a special (chlorhexidine) soap over the neck and chest for five days before surgery, along with a mouthwash and a nasal ointment. In a landmark randomized trial of essentially this same regimen, deep surgical-site infections fell by roughly 79%,^[1] and the orthopedic implant literature showed the same pattern — including zero staph infections among 321 decolonized joint-replacement carriers in one prospective study.^[2],[3] I use it routinely for every patient.
• Prepping the surgical site and giving IV antibiotics before the incision — standard, and always done.
• During surgery, I irrigate the surgical wound with saline containing antibiotics.
• A few days of antibiotic pills at home afterward.

With all of this done, the risk of infection is very low — typically around or under 1%. (For honesty’s sake: all three infections in our published series occurred across the whole study period; since standardizing this protocol, our own rate has been under 1% too.^[4]) If an infection does develop and it’s caught early and isn’t too deep, it may be treatable with antibiotics alone. But at times, the device may have to be completely removed.

Injury to the nerves we work around

There are two nerves near the surgical field. The first you know about: the hypoglossal nerve, the nerve that controls your tongue — the one we’re stimulating. The second you may not: the nerve that controls your lower lip.

Either nerve can be weak after surgery, and when it happens, it’s almost always temporary. If the tongue nerve is weak, you may notice your tongue bending slightly to the right when you stick it straight out, a bit of slurred speech or a minor lisp, or — in more significant cases — trouble swallowing. Mild, temporary tongue weakness was fairly common in the early trial era, but as a discrete complication it shows up in under 1% of registry patients — and no case of permanent tongue weakness was reported in either the STAR trial or the ADHERE registry.^[5],[7] Permanent weakness is possible, but in my experience it is very, very rare.

The lower-lip nerve is very small and sits close to where we operate, and even a small stretch can weaken it temporarily. After a right-sided implant, you might notice in a big smile that the right side of your lower lip doesn’t pull down quite as much as the left. This almost always improves with time, but a subtle — or occasionally more noticeable — asymmetry can persist, and even a very careful surgery can’t avoid this 100% of the time. It’s important you’re aware of it: in one of my studies, patients in online support groups brought up lip weakness far more often than official databases record it (6.8% of patient-described events vs 0.4% of federal reports)^[13] — one of the reasons I make a point of discussing it before surgery.

Pneumothorax (a collapsed lung) — a risk the newest device has essentially eliminated

In earlier generations of the device, a separate breathing-sensor lead was placed in the chest, and with it came a small risk of pneumothorax — air around the lung. I led a national study on exactly this question, and the answer was reassuring but instructive: among experienced, high-volume sleep surgeons the rate was 0.21% (8 in 3,823 implants), versus 3.4% in a general surgical population — a sixteen-fold difference.^[10] When it happened, it often required a chest tube — half the cases in my study, and most of those in the national database.^[9],[10]

Today, this is largely history: the current generation — Inspire V — no longer uses a separate sensing lead at all, so with Inspire V there is very little to no pneumothorax risk. I include it here because it’s a good example of how this technology has matured, and because the underlying lesson from my study still applies to every risk on this page: your surgeon’s experience with this specific operation matters. It’s a fair question to ask any surgeon: how many of these have you done?

Neck tightness from the connecting wire

Inspire’s stimulation cuff sits in the neck and the battery sits in the chest, connected by a small wire tunneled beneath the skin. Over time that wire can scar to the surrounding tissue, and when it scars, it can get stuck in place. What that sometimes looks like: when you look straight up at the ceiling, you can feel — even see — a tight band in the neck.

This almost always gets better with time, and many patients never notice it at all. The best prevention is neck rolls, using a protocol I originally developed that has since spread around the country: ten full circles one way, ten the other, at least three to five times a day in the weeks after surgery, to keep the wire mobile before scar can fix it in place. Don’t be alarmed by some early tightness — that’s fairly normal and should dissipate. But you should know that in some patients the band can be tight and uncomfortable enough that they’ve requested removal of the device or a surgical revision to fix it.

Scarring

Any incision forms scar tissue, and people heal differently. Some heal so well the scar is essentially invisible; others form hypertrophic scars or keloids — large, noticeable scars that can be painful and bothersome. If you know you form these, tell your provider so measures can be taken to mitigate a painful or unsightly scar. Unpleasant scarring isn’t expected, but it can happen to any patient.

Hardware problems

We’re now on the fifth generation of the Inspire device. It’s a mature technology, and many of the hardware problems of earlier years have been resolved — problems people faced in the past are no longer likely to occur. That said, any medical device can ultimately fail, and Inspire is no different. The hardware can malfunction in different ways, and a malfunction can require revision surgery or replacement of that part.

To put numbers on it: in the largest real-world analysis, about 1.5% of patients needed some revision surgery within the first year, rising to about 3.6% by year three; device removal occurred in 0.7% by year one and 2.7% by year three.^[8] My own center’s experience with the breathing-sensor lead of earlier generations: 2.1% of our patients needed a revision for a sensing-lead malfunction^[14] — a component Inspire V no longer has at all, which is exactly the kind of maturation I’m describing. Rarely — about 0.2% of cases nationally — a lead can even work its way through the skin; I’ve published on how we successfully manage that without losing the device.^[15]

And one thing that isn’t a complication — but you need to know it

Inspire is not a guaranteed cure. It’s not guaranteed to cure your sleep apnea, not guaranteed to cure your snoring, and not guaranteed that you’ll tolerate the stimulation. Rarely, we have patients who don’t improve at all — even when we expected them to do well beforehand, the surgery was technically flawless, and the device works exactly as designed. For reasons we don’t always completely understand, it just doesn’t help their sleep apnea.

The published numbers match that honesty: in the pivotal trial’s five-year follow-up, roughly two-thirds to three-quarters of patients met the formal definition of surgical success,^[6] and in my own center’s series it was about 77% — which also means roughly one patient in four falls short of that bar.^[16] Many of those still improve meaningfully; a few don’t. You should be aware of this scenario and know that Inspire is not a guarantee.

Please also be aware that the Inspire battery lasts about ten years, so you will need repeat surgeries roughly every ten to eleven years to replace it.

Every number in one place

A note on reading these numbers honestly: different studies count differently. Trial percentages count anyone who ever reported a symptom during follow-up of a small cohort; registry and database figures count discrete events across thousands of patients. Where the ranges differ, I’ve shown both.

My research on complications

I find it critical to have a really thorough discussion with each of my patients about the possible risks — and it’s been a focus of my career to research complications as much as possible, so that I can prevent them from happening as much as I can. These are the studies I’ve contributed to the literature specifically on the safety of this procedure: