Hydrogel injections – too good to be true?

The allure of instant contouring of the buttock or breast with an injectable filler is pretty strong.  It sounds like such a promising concept – a few quick injections, no invasive surgery – and voila!, instant shaping.  Search the internet, and you’ll see lots of sites about hydrogel injections for instant buttock augmentation.

Question:  what injectable material can be used to do this safely?
Answer:  there isn’t a good one yet.  Read on; I’ll explain.

The perfect filler would have to be 100% biocompatible – that it caused no reactions from the body, such as allergies, granulomas (lumps) or delayed hypersensitivities.  The filler would also have to stay where we put it, and not migrate.  And it would have to keep it’s original shape, and not be reabsorbed.

Combining these properties is a real challenge.  So far, we really don’t have anything that matches all the criteria, let alone passes FDA scrutiny.

So, what exactly is this hydrogel stuff?  A hydrogel is any gel-like substance that is mostly water.  Hair gel, ultrasound gel, Jell-o and KY gel are all well-known examples of hydrogels.  (But I don’t think anybody in their right mind would want to use those as an injectable product!!)  Some sort of chemical polymer, which is present in a small percentage, is responsible for gel’s physical properties.

Restylane and Juvederm are also hydrogels.  They are hyaluronic acid (HA) gels.  They work very well, have extensive research behind them and are FDA approved, but are temporary fillers, and are too expensive for large volume injection.

Outside the U.S., there are literally dozens of other hydrogel products, made with things other than HA’s. There’s a lot less scrutiny and regulatory oversite outside the U.S., so there’s been a huge proliferation of these fillers.  They are often advertised as being 100% biocompatible, but scientific research has shown that this is often not really the case, and sadly, that long-term problems do occur.

The hydrogel “Interfall” was developed in the Ukraine, in the early 1990’s.  It was the original polyacrylamide gel (“PAAG”).  It seemed like a great idea – and was initially quite popular outside of North America.  Interfall inspired a bunch of imitators – Cosmogel, Argiform, Amazing gel, Formacryle – and is still easily available on the internet.  With time, reports of major, unfixable problems came to light (link1) (link 2)(link 3).  I believe it’s still manufactured in China, although it’s been banned from use there since 2006.  In any event, it’s not FDA approved, and I certainly wouldn’t recommend it….even though you can get it on the Internet.

Although newer, supposedly better, generations of PAAG fillers have been developed, we’re still not sure that they are trouble free.  For example, Aqua-lift, a Russian hydrogel filler product, had a major product recall as recently as December 2010.  Longterm studies on the safety of Aqualift are still pending.

A Danish product, Aquamid, is currently undergoing FDA review.  Safety data out to 24 months looks OK, but that is still “early” when you consider that aquamid is a permanent product.

Bottom-line:  One day, we’ll probably have an injectable hydrogel product that actually works safely and effectively.  But that day isn’t here yet.  Until these filler materials pass American testing standards by the FDA, do not use them for breast, buttock or other soft tissue augmentation.  No reputable doctor injects these materials.  Just say no.

Fat injection or buttock implants are currently the only FDA approved methods for buttock augmentation.

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