I’ve been in the Navy for 17 years, and the majority of that has been focused on breast reconstruction after mastectomy, specifically the last seven to ten years. Like Dr. Spiegel, I am constantly in the process of trying to push for better outcomes with lower complications for my patients. The expectations are really high in this space. The technology and the ability to reconstruct an aesthetically pleasing breast have advanced very rapidly, and that is what our patients now expect.
When I introduced this system at my hospital, after hearing about it at a very intimate women’s symposium, I was not in the mindset of “I need to make this better for my patient’s recovery process,” or “I need caregivers to not have to manage their loved one’s body fluids.” My full intent was to achieve a higher level of reconstructive outcome and success for each of my patients. There are other applications, but the reconstructive outcome and the longevity of the result are what I want to talk about, and how SOMAVAC contributes to that success in the breast reconstruction space.
Keep in mind that this is my anecdotal clinical opinion. I don’t have any disclosures, and this is not the opinion of the United States Navy. This is my professional, personal opinion. I do feel it is highly superior to drain bulbs. It’s easier to track the output, there’s less human error, and the actual removal of the fluid is far more effective from what I have seen in my practice.
Why is complete evacuation so important? It has to do with the way we recreate the reconstructed breast. The layers of tissue required to support the position and shape of the reconstructed breast, or the internal breast prosthesis, will not successfully heal or stay in place without properly managing the support structure around that implant. We use acellular dermal matrix, a graft from a human tissue donor processed and prepared specifically for breast reconstruction. The bottom line is that the ADM will not incorporate and survive the transplant process in the presence of improperly managed surgical site fluid. It’s placed to create a support sling for the device and to add support and thickness to the skin, and if fluid accumulates between the skin and the tissue, it will not grow into place and provide the support we need those tissue layers to perform.
Historically, we left this process of tissue incorporation to chance and used a bulb management system invented 50 years ago, which led to pretty inefficient and ineffective evacuation of fluid. Inconsistent suction. The patients are turning the suction on and off as they’re emptying the bulbs. You really have no idea what’s going on at home, and everyone is doing it differently. That makes it very difficult to implement a change in your reconstruction and actually see the results, because of the differences in how patients are managing the drain system.
So what happens when surgical site fluid is not well managed? I’ve had patients present extremely engorged after a bilateral nipple-sparing mastectomy, where the seroma fluid was not properly evacuated or continued to accumulate, and in those cases the implants had to be removed. Many patients end up with a complication like persistent seroma or infection of the implanted material. It’s really not hard to imagine that when normally occurring skin bacteria is bathing in warm body fluid, it creates a petri dish for bacteria to flourish. It colonizes all of the materials we’ve used in the reconstruction and they end up with a reconstructive failure: more hospitalization, more visits, a lot of grief for the patient and the family, and an extremely significant loss in material costs that have to be replaced later. The majority of my patients with this type of complication will need to go flat for a period of time and wait six months or more to restart the process, if they’re even amenable and not overly traumatized by the experience. That is exactly what we’re trying to avoid.
SOMAVAC is superior because it’s easier for the patient and it helps us track the volume, so we know what’s going on with the system. But what’s really critical is the constant level of suction. The negative pressure allows the tissue layers to really heal together, so fluid is not accumulating between those two layers, and it lets us create the reconstruction we spent all this time and resources to put in the patient.
I had a patient three weeks ago, a 35-year-old mother of two little kids. She underwent a bilateral nipple-sparing mastectomy and they were able to preserve her skin, nipple, and areola very well, even though she had an invasive breast cancer. She was able to undergo an immediate reconstruction directly to silicone implants and was provided with a SOMAVAC drain management system. She had already heard about the system from my cadre of patients who have used it. They pretty much all demand that they get the new device from Dr. Kemp for their drains. She had her drains for a total of only six days. She is a small-breasted woman, so less time with drainage is likely partly due to smaller tissue volume, but also to more effective removal of that fluid, which keeps the space clean, keeps it healing properly, and keeps them moving forward in their recovery. She’s still a bit swollen, but her implants are in good position, well supported by the integrated dermal matrix, and she’s able to comfortably wear a bra and go about her day-to-day activities in normal clothing only two weeks out from surgery.
The implementation is another piece I want to discuss. It’s really a bit frightening to introduce a new system into your clinic, your OR space, the surgical wards, so sometimes I’m hesitant to do that. But this process has gone so smoothly it could not have been better. The clinical experts on the team helped us so much. Once we had the system on hand, the process was pretty hands-off for me and the other surgeons in my cancer care center. They came and did the hands-on training in the various locations of impact for our system. They had a strategy and implemented it successfully without me even getting involved, aside from providing points of contact. Zero regrets on my end.
On cost: this human tissue takes an extreme amount of effort to create, process, and make acceptable to place into another human, so that material is extremely costly. If you’re doing a bilateral mastectomy with a very large piece of this mesh to support a medium or large implant, you’re looking at probably between $10,000 and $20,000 for each breast of that matrix. There are many companies making it at various prices, but none of them are cheap. When I come out of a breast reconstruction, I may have already spent $40,000 in material costs between the implants and the acellular dermal matrix for one patient, and to then have that fail is just devastating. Not only because it is human donated tissue from a person who was deceased and agreed to donate, but also because of the loss to the hospital system, to the patient’s time, and to the caregivers, who all go through a very traumatic experience when we lose a reconstruction and have to start over. The cost comparison of the SOMAVAC system is really a no-brainer for me.
I’m very excited about what I see in the future for this device, and I’m hoping we can push it forward in other systems, because it matters. It is devastating when we lose a reconstruction due to something as simple as fluid. The staff and the patients have all really enjoyed the change and the experience with the system, so the word has spread. It’s now no longer acceptable to put drain bulbs on my patients.