Bio-materials Used in Revision of Breast Augmentation – Strattice, GalaFLEX and GalaFORM

The Need for Additional Soft Tissue Support


Sometimes a breast revision is needed but the existing breast tissue does not have the required strength to support the required repairs. Rather than making do with the tissues available, and accepting a much higher failure rate, there are fortunately some very good options in which bio-materials can be placed inside the breast to provide the necessary support. My favorite two materials are Strattice and GalaFlex/GalaForm. In the past, I used a product called “Seri”, which was made from silk. While I had very good success with it, it is no longer available. I have replaced it with GalaFlex/GalaForm, and continue to have success with this product. While both Strattice and GalaFlex/GalaForm provide support to the breast tissues, I have specific situations where I like one product or the other.

Strattice™

Strattice is a tissue substitute that may be used in various breast procedures. The scaffold is designed to achieve several goals, including:

  • Adding strength to the breast pocket.
  • Securing breast implant position under the pectoral muscle.
  • Provide an additional layer of support and protection for breast implants.
  • Increase the thickness of the breast tissue to decrease the risk of ripples or wrinkles in patients with thin tissue.
  • Diminish the risk of recurrent complications after revision breast surgery (bottoming out, symmastia, and other problems).

What is Strattice made of?

This acellular dermal matrix (ADM) is made from porcine (pig) skin that has been processed to remove all living cells – hence the term “acellular”. Dermis is the strength layer of the skin below the epidermis and above the fat. The end product is a flexible sheet of sterile connective tissue. This matrix is inserted in areas of the body where reinforcement is needed, acting as a scaffold. When Strattice is placed in the breast mound, the body’s own cells will integrate into the mesh, where they can remain indefinitely.

Some patients are uncomfortable with the tissue source of Strattice. However, it is important to note that pig insulin has been routinely used in the treatment of diabetes, and bovine-derived collagen injections are also administered, both without high instances of adverse reactions. There is another ADM alternative to Strattice. Alloderm is a similar product but obtained from human cadavers. The cost is also much greater than Strattice, which is already very expensive. This is why I prefer Strattice.

Is Strattice Mesh Absorbable?

The Strattice tissue matrix does not dissolve. It sits in the breast and becomes a scaffold for cells to grow into it. After several months, the sheet of connective tissue is home to thousands of your own cells. It will feel just like natural breast tissue.

Does Strattice Mesh Need to be Replaced?

The body’s cells integrate throughout the mesh over time, stabilizing tissue for many years. There should be no need to replace the tissue matrix once it has been placed.

When Do I Use Strattice?

Strattice is about twice the cost of GalaFlex/GalaForm which is discussed below. It also requires the use of a drain, which I normally do not use in my primary (first time) or revision breast surgeries. However, Strattice has been shown to be extremely useful in treating recurrent capsule contracture or those at very high risk for the development of capsule contracture. Patients at high risk for capsule contracture usually fall into one of these situations:

  • Recurrent capsule contractures in one breast
  • Bilateral capsule contracture

Strattice may also be used in the first time capsule contracture patient. The justification for this is that the success rate with Strattice is approximately 100% in treating capsule contracture versus approximately 73% when treating capsule contracture without Strattice.

GalaFORM/FLEX Surgical Mesh

GalaFORM/FLEX is a mesh product designed to support weak or thin tissues and help the skin and soft tissue rebuild itself with collagen and elastin proteins. Like Strattice, GalaFLEX is an added scaffold that supports breast shape. This matrix has a trellis-like pattern that encourages cellular growth around it over time. This product incorporates into breast tissue within a couple of weeks. The difference between this product and Strattice is that GalaFORM/FLEX is comprised of an artificial material that is absorbed completely in approximately one to two years. It is replaced with a new layer of scar tissue that is your natural tissue and is strong enough to add lifelong support to your breast tissue. GalaFORM and GalaFLEX are comprised of the exact same material. GalaFLEX is a flat sheet, GalaFORM is a curved shape. For the purpose of discussion, I will now refer to the product as GalaFLEX, but all comments apply equally to both GalaFLEX and GalaFORM unless so indicated otherwise.

Does GalaFlex Mesh Dissolve?

GalaFLEX is made of poly-4-hydroxybutyrate (P4HB™), a dissolvable micro-filament that provides immediate support for breast tissue. The mesh smartly knows when to break down so the body can metabolize and therefore completely eliminate it. Generally, soft tissue growth reaches 1mm thickness in about 6 weeks. By six months, the thickness of the soft tissue has reached 3mm. About one year after the insertion of the mesh, tissue thickness is sufficient to perform without the additional support. At this point, GalaFLEX begins to deteriorate. Approximately 18 to 24 months after surgery, GalaFLEX has completely dissolved and been absorbed in the form of carbon dioxide and water.

What Causes Breast Implants to Bottom Out?

“Bottoming out” is the term used to describe the disposition of a breast implant to a position on the chest wall that is below the inframammary crease. This problem can occur if breast tissue is too weak to support the size of breast implants selected. Bottoming out may be more likely to occur when implants are placed over the muscle, and may occur if a woman smokes, exercises without a support bra, has naturally poor quality breast tissue or loses a substantial amount of weight.

Fortunately, instances of severe bottoming out are uncommon. If the problem does occur, it can be corrected with revision breast surgery.

How Long Does it Take GalaFlex Mesh to Work?

GalaFLEX works immediately. This tissue matrix may be used to support longer-lasting results from mastopexy more than to enhance the visible results of surgery. The breasts are not lifted more so due to the placement of GalaFLEX. Where we see the benefit of this technique is in the extent of breast position change after mastopexy. One study demonstrated that GalaFLEX limited breast position change to 10% for two years after surgery, a fraction of what occurred in patients without the surgical scaffolding. I also like to use GalaFLEX in my non-implant, breast lift (mastopexy) patients, especially those who sustained massive weight loss with extremely damaged, sagging breasts.

Are There Any Risks with Using Strattice or GalaFlex Mesh for Breast Augmentation?

The risks associated with these acellular dermal matrices are low. Possible complications include infection, seroma or hematoma, inflammation, prolonged skin redness (Red Breast Syndrome), and skin necrosis. In one small study, the use of porcine Acellular dermal matrices resulted in fewer complications than human tissue scaffolds. Dr. Epstein takes every precaution to ensure our patients receive the safe, meticulous care they deserve.

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Are you interested in learning more about breast augmentation, breast lift, or revision breast surgery? Call 631.689.1100 to schedule your consultation with Long Island breast surgeon Dr. Mark Epstein.



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