Dr. Michelle Roughton what are you thoughts on the Sientra silicone implants? I googled them and some pretty wild stuff came up about them. it's been said that they are still using the Silimed implants that they were not supposed to be using anymore. My reason for asking is because I was looking to exchange my salines for these. My doctor said they make a better implant, now I'm scared to use them.
"On September 23, 2015, the MHRA suspended all CE certi- fication for Silimed medical devices after German inspectors found particle contamination in devices manufactured in Rio de Janeiro.19 The Australian regulator, The Therapeutic Goods Association20 and Brazil’s national health surveillance agency also followed by conducting an independent inspec- tion. On October 9, Sientra, who had contracted Silimed to manufacture their proprietary implants, voluntarily sus- pended all implant sales in the United States as a precaution. Sientra is a US-based company that developed a nonpoly- urethane texture manufactured utilizing ammonium carbo- nate vulcanization.21 One month later, on October 23, 2015, a fire destroyed one of the Silimed manufacturing plants in Brazil. Sientra has now dissolved its manufacturing agree- ment with Silimed and established US manufacturing plants in Wisconsin to produce their implants. In 2018, after suc- cessfully submitting a PMA, Sientra obtained approval for its Opus range of implants from the FDA, which are now avail- able for use in the United States" https://doi.org/10.1093/asj/sjy310
Essentially I have no idea what was going on in Brazil BUT now are manufactured in Wisconsin and should be safe, no longer contracted with Silimed. We use Sientra about 50% of the time and I have been very happy so far with each outcome. Hope this helps!
I would be honored to see you at my office in Raleigh, NC!
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