Galaflex (P4HB) mesh in the breast - what and why.
December 20, 2022
November 6, 2023
.
By Dr. Andrew Campbell-Lloyd

Galaflex (P4HB) mesh in the breast - what and why.

A quick trip to the USA over the last weekend (ostensibly to meet some boring CPD requirement) was also an opportunity to take the pulse of American plastic surgery at the annual American Society conference in Austin. Fortunately, there was a reasonable program looking at revision breast surgery amongst other things, and a couple of trends certainly have been highlighted,and I think they are relevant to Australian patients.

First thing to say – there was (as always) barely any discussion on explant procedures, apart from a single pre-recorded session. Disappointing, not least because most of the revision surgery panels at least acknowledged the fact that explant is massively on the rise.

Secondly (and this is a big change), there was also a suggestion from some of the big names that they are finally shifting their practices away from pushing breast implants, especially where ladies are seeking rejuvenation of the breast. A couple of US surgeons with high profiles indicated that where previously they were using implants in around 70% of their mastopexy cases, now that number has dropped to perhaps 40%. That is an interesting acknowledgement of patient sentiment if nothing else. There were major conversations about the use of “auto-augmentation” techniques (which I have been doing for ages now but these have certainly NOT been the norm in Australia) and there were a few little technical ideas that popped up which I think I will consider in how I do my procedures.

This second point then leads to what I consider the big take-away from the conference: MESH.

P4HB meshes (which in Australia means Galaflex) are having a moment and this is, in my opinion, a good thing, most especially where they are replacing the human-derived ADMs. The Americans have always been quite aggressive in their use of ADMs in cosmetic patients, whereas in Australia, we have typically reserved them for use in reconstructive cases, mainly due to cost. The other issue with the ADMs (and to an extent, a similar issue applies to the animal derived products I have preferred in the past) is their tendency to increase the risk of complications, which has certainly held back (or indeed totally precluded) their use in elective cosmetic work. So the introduction of Galaflex mesh to the Australian market in 2021 has finally given us access to a high quality dissolving synthetic product which meets our requirements for use in the breast, with a far lower risk of complications compared to ADMs. Unfortunately it is still “off-label” use (which means insurance doesn’t cover Galaflex, but that isn’t an issue for cosmetic cases) but the cost point is far lower than that of the ADMs (such as FlexHD) which are otherwise available.

So, it is probably an ideal time for me to talk about Galaflex: what it is, how we use it, and why it is the best option currently on the market. It is worth contrasting this part of the discussion to a recent article where I mentioned the fact that other surgeons are choosing to use permanent meshes like Ti-Loop.

Galaflex is the only mesh currently available that I recommend.

Galaflex is a dissolving synthetic mesh made of a substance called poly-4-hydroxybutyrate (P4HB). In a way, the stuff it is made of is a little bit like the dissolving sutures we use to close wounds. The idea of using materials like this is not new, but the properties of the P4HB are a little different to other meshes and in particular, the absorption profile means it is well suited to the breast for the support of implants in particular (which in my hands, means implant revision). Whilst those lovable Americans are chucking this stuff in all over the place, including for primary breast augmentation in ladies who just want big implants, my feeling is that the role of this product should be irrelevant in primary cases because the surgeon should be able to create the necessary control with natural tissues only. Where it is really valuable is where control has been lost (see my last article on breast implant revision), or where the control never existed in the first place (typically in ladies who need a mastopexy with an implant and who have poorly defined breast boundaries). Head over our website to read more about breast implant revision in particular, which is where a dissolving mesh as part of an "internal bra" construct can be so valuable.

Why would we want a mesh in the breast?

The battle we continue to fight with breast implants relates to the durability of the cosmetic result. Some of the major reasons that ladies seek revision breast surgery relates to the way either the implants or the breast tissue can move out of position over time. I have discussed the reasons we revise breast implants in the past and you can also read more here.

This issue is exacerbated in ladies who have relatively poor soft tissues (in some cases this is just bad luck, in other cases it may relate to things like prior weight loss, or in cases of mastectomy for breast cancer the removal of the breast tissue takes away most of the supporting elements in the breast) and it is also exacerbated by changes in the size of the natural breast (the most common example being pregnancy after an earlier breast augmentation).

So, revision procedures typically require controlling the breast implant, controlling the natural breast, or both! In these cases, the use of mesh creates stability by bolstering the strength of the natural breast tissues. When we place a mesh like Galaflex, it dissolves slowly over a period of about 2 years. During that time, it supports the breast and the implant, and once it has fully dissolved,the layer of tissue which replaces the mesh is stronger than the natural breast tissue which ensures longevity of the surgical outcome. These are really good arguments for use in my books.

Up til now I have really only used Galaflex for ladies who’ve had operations like nipple sparing mastectomy, with an implant-based breast reconstruction, and typically then only in the setting of revision(rather than at the time of the primary reconstruction). There is certainly a cost consideration when using Galaflex in cosmetic revision cases (it does add about $3000 to the overall cost of surgery) but I have been considering expanding the way in which I do use Galaflex for a little while. Always reassuring to see that I’m not operating out on the lunatic fringe when the Americans seem to have been having the same thoughts.

So those were the major ideas I took away.

Unfortunately, whilst the conference reinforced that explant surgery is still not being given the consideration I think it should be, it will be interesting to see how this evolves in time. Where 5 years ago most surgeons weren’t really thinking about ideas like “neopockets” in revision surgery, or “auto-augmentation” in mastopexy, this year these ideas were really the hot topics of discussion. So, you never know, maybe next year everyone will be talking about explant surgery like a bunch of actual grown-ups.

 

The final point I think is worth making is the general tone of how the American system is accommodating plastic surgery, and how that parallels the situation in Australia. I have been meaning to discuss (for sometime) the issues plastic surgeons are currently having accessing private hospitals (in Adelaide in particular), and the increasingly concerning behaviour of many private hospitals in limiting the access of privately insured women who require breast surgery. I will talk more about this in the near future. I think for now, it is enough to say that there were very few speakers at this conference who weren’t running their own day surgeries. This is dramatically different to how things stand in Australia, but the reasons for that are likely to play out over the next few years here. The insurance industry in America is very different to ours, but many surgeons are no longer willing to engage with health insurers, and instead run their own facilities as full-fee paying day hospitals. They focus on efficiency, efficacy, and outcomes, and ultimately they believe that they can provide better service for their patients in this context. It may be that if we continue to follow the current trajectory, plastic surgeons in Australia will find themselves in the same boat.