In my previous post, I discussed the availability of shaped silicone gel implants from Sientra. This product line is a big step forward toward broadening the implants that are available for us in the USA. However, the Sientra shaped device is not the ‘form stable’ or ‘gummy bear’ implant that we have all looked forward to using for years.
Internationally, the so-called ‘form stable’ silicone implants by Allergan and Mentor have been available for a long time. Here in the USA, we await their FDA approval. Many senior surgeons across the USA have had access to these form stable devices as part of study protocols. I am not one of the lucky few, but I did place a few form-stable implants when I was doing my training in the Pacific Northwest.
They are great devices for a number of reasons – differential shaping and volume between upper and lower pole, texturization, and durability. The delay in their release is interesting – why has it taken so long for Mentor and Allergan to get their form-stable devices approved by the FDA ? I’ve asked several of my senior colleagues who used the implants during the pre-market approval studies (which are now closed) – nobody has a good answer. I’ve spoken with the product reps – mum is the word. So nobody knows, or at least nobody is talking about why these devices are held up in FDA approval pergatory. I won’t speculate why – I don’t understand it.
For now, I’m looking for a few patients in Seattle WA to offer the Sientra shaped gel implants for breast augmentation purposes. The availability of this textured and shaped (but not form-stable) silicone implant will make the wait for the form-stable implants (style 410 and CPG) much easier to deal with.