Sientra, the makers of the breast implants that we predominantly use in our practice, has run into some manufacturing issues and has pulled their breast implants from the US market. Let me explain.
There is really no concern about the Sientra implants according to the FDA. If you have Sientra implants, be glad, because you have probably the best implant available. However, the manufacturing plant in Brazil has come under some scrutiny by the European equivalent of the FDA because some particulate matter was found on the surface of some medical devices that are made at that plant. This matter was small pieces of silica, the base ingredient for making silicone and is not a threat in any way to patients. However, this finding put into question the manufacturing practices of the plant and there is appropriately a zero tolerance for any problems in the manufacture of medical products.
For this reason, until they sort all of this out, Sientra has elected to remove its breast implants from the market as of yesterday October 9th, 2015.
For those who are planning a breast augmentation in the near future, we will be using the equivalent of Sientra’s gummy bear implants made by either Mentor or Allergan. These are venerable breast implant companies and they have a great product.
We will keep you informed about Sientra breast implant availability as we get new information. Please contact us at Partington Plastic Surgery if you have any questions.