Why are Sientra breast implants of ANY kind still being used here in the United States?
Doctor Answers 8
Sientra Breast Implants.
The reasons for the suspension of Sientra implant sales is related to issues of manufacturing processes and no adverse patient outcomes have been identified either outside or within the U.S. The FDA has also been involved in this issue and they also have not identified any adverse patient outcomes, nor have they recommended that Sientra implants be taken off the market. Again, this was a voluntary action take by Sientra.
I would like to believe that any responsible and reputable surgeon certified by the American Board of Plastic Surgery would provide you with truthful answers based on their complete knowledge at the time of the discussion. However, as always, you still need to do your homework.
Sientra Breast Implants and the FDA
I hope that helps.
Unless you've spoken to a plastic surgeon that has not gotten the news, Sientra and the FDA have been working hand in hand to halt all surgeries using their products. There is no way to purchase any Sientra implants at this time either. This has been the case for the last two weeks.
Find a reputable surgeon and they'll confirm this.
Best of luck!
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Sientra Breast Implants
As of this past friday, Sientra breast implants are not being shipped to the United States. This was a voluntary decision by the president of Sientra not forced on to the company by the FDA or any governmental agency.
There is a problem in the manufacturing of the devices in Brazil where the implants are made. There are no adverse reactions or health issues at this time according to Sientra. The company is just being very safe and responsible until the problem is resolved in Brazil.
That is really all they are telling us physicians at this time.
Your mistrust should not be directed toward a plastic surgeon if that is all we are being told at this time. As more news from Sientra is available, the more we can inform our patients.
Why are Sientra products being used?
Sientra, Inc. a medical aesthetics company, today announced that it has sent a letter to plastic surgeons regarding products manufactured by Silimed, one of Sientra's contract manufacturers.
Among other things, the letter updates plastic surgeons on actions Sientra is taking:
- Sientra has been in ongoing discussions with the United States Food and Drug Administration (FDA) regarding Brazilian regulatory inquiries into Silimed products, and is conducting its own review of the matter.
- Out of an abundance of caution, Sientra is voluntarily placing on temporary hold the sale in the United States of all Sientra devices manufactured by Silimed and also recommending that plastic surgeons discontinue implanting these devices until further notice.
- Brazilian and other regulatory agencies have reiterated that no reports of adverse events and no risks to patient health have been identified in connection with implanting Silimed-manufactured products, and, accordingly, there is no need to explant or adopt any specific procedure or action for those patients who have received them.
October 9, 2015
Dear Valued Plastic Surgeon,
As a valued partner to Sientra, we want to ensure we are communicating with you in a timely fashion about the latest information regarding our products.
As we previously announced, we learned that Brazilian regulatory agencies have temporarily suspended the manufacturing of all medical devices made by Silimed, including products manufactured for Sientra, as they continue to review technical compliance issues related to Good Manufacturing Practices (GMP) at Silimed's manufacturing facility.
We have been in ongoing discussions with the United States Food and Drug Administration (FDA) regarding this matter and out of an abundance of caution, we are voluntarily recommending that you temporarily discontinue implanting all Sientra devices manufactured by Silimed. We are also voluntarily placing on temporary hold, the sale in the United States of all Sientra devices manufactured by Silimed, and we ask that you set aside all such devices in a secure location and not use them until further notice.
Let me emphasize that we are taking these steps as a precautionary measure. It is important to note that no reports of adverse events and no risks to patient health have been identified in connection with implanting these Silimed-manufactured products. Furthermore, neither Brazilian regulatory agencies nor any other regulatory authority has found that there is a need to explant these devices or adopt any specific procedure or action for patients who have received them. This finding has been reiterated by the foreign regulators reviewing this matter in their public announcements.
In the meantime, you can continue to reassure your patients as needed by informing them that there has been no indication that these issues would pose a threat to their safety. Furthermore, you should continue to advise your patients who have received Sientra implants to contact you if they experience any complications, consistent with standard patient follow up.
We value the relationships we have built with you, and the safety of your patients is of the utmost importance to us. We are providing this update to ensure that you have all the relevant facts about the steps we are taking now and are committed to taking moving forward. In addition to our discussions with the FDA, we are conducting our own review of this matter. Once we have completed our review, we will make sure you are apprised of any pertinent, additional information. Rest assured that this is a top priority for our company and we are committed to completing our review expeditiously, but thoroughly.
In addition to reaching out to you directly, we will also be posting updates to our website, As always, I am available along with my team to address your needs and inquiries. Please do not hesitate to contact us via our information request line at email@example.com, or by calling us at 888.708.0808.
Thank you for your patience, understanding and support throughout this process.
Founder and Chief Executive Officer