Potential Risks

There are potential risks and less-than-ideal situations from any surgical procedure.

People have even been forced to have their toe amputated after an ingrown toenail removal. Once in a while, at no fault of the surgeon, the device, nor the HyProCure recipient a less-than-ideal situation arises. You need to understand the good, the bad, and the ugly of this procedure. Thank goodness the overwhelming majority of cases are good.

General issues related to cutting the skin

  • Chance of delayed skin healing
  • Infection
  • Drainage from the incision site
  • Scar
  • Reaction from stitches

Issues directly related to implant

1. HyProCure can become displaced.

There is always a chance that HyProCure can become partially or fully displaced because we are at the mercy of the bones forming the space and the tissues within the sinus tarsi’s ability to attach the anchoring section of HyProCure. It is possible that the tissues are non-existent or they are very frail. Walking or running too soon after the insertion of HyProCure before the tissues adhere to it is another reason for displacement. Also, it could be due to the surface anatomy of the heel and ankle bones. Even though HyProCure was placed correctly, it could become displaced.

The good news is that there is a wide variation where HyProCure can still do its job to stabilize and improve the alignment of the ankle bone even when it’s not in the ideal position in the sinus tarsi.

As long as HyProCure is stabilizing the ankle bone without causing any pain, then it’s ok to leave it be. There have been situations where HyProCure shifted several millimeters from its placement in the operating room. The surgeon was not satisfied with the placement of HyProCure, even though the ankle bone correction was excellent. The surgeon took the patient back to surgery to position HyProCure deeper into the space. He took x-rays to show the deep placement in the operating room, but then when he took follow-up x-rays several weeks later, it again shifted because HyProCure is going to find its final location within the sinus tarsi due to the surface anatomy.

There is an ideal placement where we’d like HyProCure to sit within the space, then there’s the placement where it is going to function the best for the sinus tarsi. Again, just as long as the ankle bone is stabilized and there is typical recovery pain, not pain from the implant being displaced, it is better to leave it be. Watch and wait. If it further displaces or there is a loss of correction, then a revision procedure is called for, or maybe an entirely different option is best for this situation.

2. You can have prolonged pain in the area below your outer ankle bone.

The ankle bone being internally stabilized on the heel bone is going to force the foot, ankle, knee, hip, and back to become better aligned. The body is going to have to adjust and there will be a potential period that you will walk not normal. It is important that the surgeon has identified other areas of the foot that could compromise the long-term success of HyProCure. That is why you must go to an experienced HyProCure surgeon.

If ankle bone instability is present in both feet but only one side is fixed with HyProCure, it could lead to prolonged ankle soreness. That’s like putting new tires on one side of a car and leaving the old, worn-out tires on the other side of the car. Of course, the new tires are going to get worn out quickly. It’s the same with our feet; both feet will eventually need to be realigned with HyProCure. The first foot that was fixed with HyProCure will continue to be painful/sore until the opposite foot is also fixed.

The second biggest cause of soreness to the outer ankle bone is due to walking with worn-out shoes. This over-stretches the outer ankle bone ligaments. If are experiencing pain to the outer ankle and have had HyProCure placed into both feet, then chances are pretty good your shoes are worn out. Throw out your worn-out shoes and buy new ones. Some HyProCure recipients who experience this outer ankle pain will require a series of injections just by the outer ankle bone. This shot is a combination of numbing medication and anti-inflammatory medication. It could be that the anti-inflammatory pills are just not working, and it is better to put the medication right where it needs to go. Relief is usually felt within a few minutes after the injection.

You must follow up with a trained HyProCure surgeon, especially if you are experiencing an unpleasant result. Some foot surgeons are against this procedure, for whatever reason, and will just want to take out HyProCure without offering any other form of effective treatment. Before having HyProCure permanently removed, make sure to exhaust other conservative forms of treatment.

HyProCure has the best retention rate over any other sinus tarsi implant, but with that said, there is a small population of people that simply cannot tolerate the correction or can’t mentally handle the fact that there is an implant in their foot, even though they have no pain.

3. Under- or Over-correction

There are many different sizes of HyProCure. There a few sizes the majority of people require, but the surgeon can never guess what size you need before surgery. There are sizers that are placed into sinus space and the foot is put through a range of motions to see if a larger, smaller, or the best size of HyProCure is required.

The ideal way to determine the size is to put the sizer in your foot, have you stand, and walk. Of course, this is not possible since you cannot get up during the procedure and walk around with a cut on your foot and a sizer hanging out. The surgeon has to use their best judgment. Sometimes, two sizes can give about the same correction. Our recommendation is to under-correct than to have an over-corrected foot. Some correction is better than too much.

Occasionally, a HyProCure recipient feels like they lost correction. This is possible but unlikely. What is probably being experienced is that inflammation and swelling of the tissues have occurred and that’s why there is more motion in your hindfoot. The only way to know is to be examined by your doctor and to check to make sure HyProCure has not shifted.

No one wants to have another surgery because of an under- or over-corrected foot but this is actually a great advantage of the HyProCure procedure. The implant can be removed, and a different sized implant can be inserted. Imagine if you had an under- or over-corrected bone surgery. This does occur and it is very difficult to fix.

4. Inability to achieve the desired outcome

It is very unlikely, but there have been a handful of situations where the surgeon was unable to place HyProCure into the sinus tarsi due to a partial bone fusion between the ankle and heel bones. This is why we urge you to have 2 sets of x-rays to show that your ankle bone can be relocated on the heel bone.

There also is the possibility where the surface anatomy of the heel or ankle bones does allow for the placement of HyProCure, but the top of the heel bone is flat. When the ankle bone pushes on HyProCure, the opposite side of HyProCure will need to be held in place. When the top of the heel bone is flat, that buttress is missing so the ankle bone simply pushes HyProCure off the heel bone. This is a very rarely reported situation but it can happen. In that case, a more aggressive surgical procedure will be necessary.

5. Loss of correction

Once in a while, a HyProCure recipient will feel like their foot isn’t as corrected as it was right after the procedure. This could be simply because the inflammation and swelling in the foot are resolved. The surgeon would have tested the motion of the foot to determine the right size and the amount of correction you should have. It is expected that there will be “more” correction early during the recovery process because of the inflammation and swelling. If you feel like you’ve lost correction, you need to get an appointment with your doctor who will order a set of x-rays to make sure HyProCure has not displaced.

6. Need for more aggressive surgery

There is a chance that your ankle bone displacement is so severe that HyProCure cannot effectively stabilize it. There also could be other parts of your foot that also need to be treated with conservative or surgical options. The foot is the most complicated structure of our body. You’ve already read that ankle bone instability can lead to many secondary pathologies.

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