WHY DO YOU USE SOFT TISSUE SUPPORT MATRICES FOR YOUR PROCEDURES?
When correcting ptosis or soft tissue malposition, we are faced with dealing with weak tissue that has already stretched over time and failed. The current method used to repair these defects typically involves reshaping and supporting the failed tissue with sutures, removing any excess tissue, and then reapproximating the remaining skin envelope more tightly around a lifted or supplemented breast. This process of correction places more demand on the very structure that has already failed: the skin. A surgical repair that only addresses the underlying structure by lifting or augmenting without reinforcing and strengthening the load bearing skin envelop is likely to result in another failure. Using a soft tissue support matrix helps build and strengthen the supporting soft tissue so that is often stronger than the original equipment. This gives patients the best chance at maintaining a strong durable result over time.
HOW STRONG IS ABSORBABLE MESH?
The initial strength of absorbable meshes vary depending on the material and manufacturing process. What is more important than the initial strength is the strength retention of the mesh over the healing period. For example, P4HB mesh monofilament fiber has the initial tensile strengths that exceed both PDS II and Prolene monofilament sutures and even more impressive is that the P4HB mesh retains 50-70% of its original burst strength at 4 months and provides wound support for up to 52 weeks.
WHAT IS ABSORBABLE MESH CONSTRUCTED FROM?
Each manufacturer creates an absorbable mesh from different biopolymers or other synthetic materials. For example, Seri is made from a multifilament silk, TIGR made from a combination a multifilament PGLATMC / PLATMC and Vicryl from a multifilament PLGA material. I choose Galatea Scaffolds because they are made from P4HB (poly-4-hydroxybuterate). P4HB is a naturally occurring biopolymer produced via fermentation. There are no chemical by-products and the body resorb P4HB gently over time.
HOW LONG DO ABSORBABLE MESHES LAST?
Some meshes lose approximately 50% of their strength in a matter of days or weeks after implantation. In fact, another reason I choose to use Galatea Scaffolds is because it retains 50% strength at 16 weeks in vivo and provides a gradual transfer of strength to host tissue over the course of 52 weeks. It is essentially fully resorbed by 18 to 24 months allowing the formation of mature strong healthy collagen to support the repair.
WHAT HAPPENS TO AN ABSORBABLE MESH DURING THE HEALING PROCESS?
Absorbable meshes break down by with hydrolytic or enzymatic digestion during the healing process. Enzymatic digestion can be harsh and lead to additional complications or longer healing cycles. Since Galatea Scaffolds are naturally derived from 4HB, which is already found naturally in brain, heart, liver, lung, kidney, muscle, and brown fat, P4HB mesh is simply broken down by hydrolysis via the Krebs Cycle and eliminated as CO2 and water. What is left behind at the repair site is tissue that is 3-5 times stronger than native tissue.
HOW DO YOU TACK THE SCAFFOLD DOWN? WHAT SUTURE DO YOU USE?
If you are attempting to maintain the position and/or elevation of soft tissue with the mesh, a deep fascial bite will be optimal for maintaining position over time. When setting the IMF on the chest wall, 4 to 5 stitches positioned from parasternal notch around to serratus tacked solidly with good purchase will hold the desired position of the fold. 2-0 and 3-0, Vicryl and PDS II are adequate sutures for fixation.
WHAT IS THE INFECTION RATE?
My rate of infections or complications is zero. Given that I am solely using Galatea Scaffolds which are monofilament and naturally derived, the risk of infection or complications are low. Unlike other means of soft tissue support that are constructed of braided filament fibers or human or animal dermis, Galatea Scaffolds are a monofilament and macroporous so as not to trap fluid avoiding the potential increase of risk of infection or seroma. P4HB scaffolds dissolves more slowly over a much longer period of time providing predictable support and creating a low acidic environment which is tolerated much better by the body.
WHEN DO YOU RECOMMEND USING THE GALATEA SCAFFOLD?
Currently the Galatea Scaffold Collection carries a general soft tissue support indication from the FDA. It’s is FDA approved to repair, elevate, reinforce and support soft tissue in plastic and reconstructive surgery. Clinically I have used it for capsuloraphy/pocket reinforcement, synmastia repair, lateral malposition, fold asymmetry, thighplasty, mastopexy, breast reduction, and breast augmentation revision soft tissue support.
DO THE ABSORBABLE MESHES STRETCH?
ADM and Xenograft’s lose 70% of their initial strength within the first 8-12 weeks due to enzymatic degradation. Because they significantly weaken upon implant before getting stronger, stretch can occur due to lack of support at a critical time when it is needed during the healing process.
Galatea Scaffolds in particular have been designed not to stretch over time. This is important to remember when tightening in place during surgery.
WILL INSURANCE REIMBURSE FOR SOFT TISSUE SUPPORT SCAFFOLDS?
I do not currently bill for reimbursement in my practice; however, I do know that practices have billed it as soft tissue support for insurance procedures in the past.
I HAD A BAD EXPERIENCE WITH AN ABSORBABLE SCAFFOLD IN THE PAST, HOW IS THE GALATEA SCAFFOLD DIFFERENT?
Galatea Scaffolds are made of the biopolymer P4HB. 4HB is already naturally found in various tissues of the human body, which allows it to rapidly incorporating nature makes it an ideal choice for providing durable, strong, predictable, soft tissue support without increasing the risk for undesired complications seen with other means of reinforcement. I love the Galatea scaffolds, and I have a hard time justifying not using it on my patients.
Specifically, I have received the question as it relates to Seri. Seri is a braided, silk, multifilament mesh construct which is enzymatically degraded. Braided multifilament structures have been shown to increase the likelihood of bacterial adherence. When used to close too close to the skin, Seri has been associated with red breast, exudate, lack of incorporation, and extrusion making it a difficult to use option for soft tissue support.
DO I NEED TO USE A DRAIN?
Use of a drain is procedure and patient dependent; however, I tend to not use a drain because Galatea scaffolds are macroporous and designed to allow for tissue ingrowth throughout the mesh and it does not act as a barrier for fluid. That being said, a drain will pull off any excess fluid and speed up the mesh incorporation into host tissue.
WHAT SHOULD I SOAK IT IN?
Although it may be unnecessary, I would recommend you follow your protocol that you normally use for implants, ie. saline, triple E or an antibiotic solution.
HOW LONG IS THE SHELF LIFE?
The length of time as well as the storage conditions are product dependent. For example, Galatea Scaffolds can be stored at room temperature for up to 3 years. Where as many ADMs must be refrigerated and have a shorter shelf life.
YOU ARE USING THE GALAFORM WITH A RIM, WHAT IS THE RIM MADE OF AND IS IT PALPABLE?
The rim that surrounds the perimeter of 3D Galatea Scaffolds, is constructed of the same material as the mesh; it is P4HB. It looks and feels slightly different but is designed to resorb simultaneously with the mesh and is replaced with mature type 1 vascularized collagen, just like the mesh, over time. My patients have not complained of any palpability after the procedure.