Are Sientra implants safe?

I'm about to undergo an aug, and weighing my options for silicone implants. I was recently reading that Sientra's implants got removed from the market in Europe due to contamination which makes me extremely nervous since I think they make these implants in the same plant for the US? What are you opinions on this matter and which implant would you recommend and why?

Doctor Answers 8

Are Sientra Breast Impants Safe?

I thought that I would update this question for you. Seintra implants were pulled from the market by the company on a voluntary basis by the company to make sure that there was no threat to the public but they were put back on the market March 1, 2016 after it was found that there are no problems with the implants or the manufacturing process. In fact, it was found that these implants are even better than was originally thought in terms of manufacturing standards and safety.

I hope that helps.

Best regards.

Are Sientra Breast Impants Safe?

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I thought that I would update this question for you. Seintra implants were pulled from the market by the company on a voluntary basis by the company to make sure that there was no threat to the public but they were put back on the market March 1, 2016 after it was found that there are no problems with the implants or the manufacturing process. In fact, it was found that these implants are even better than was originally thought in terms of manufacturing standards and safety.

I hope that helps.

Best regards.

Sientra implant safety

In the U.S. there is a temporary hold on sales of Sientra implants, they have NOT been discontinued. The issue was what are called contaminants found on the implant surface, not in the silicone gel itself. 
An Australian research group identified these contaminants as probable cotton lint and silicone particles, which is most likely a by-product of the manufacturing process. There is no indication that this is a sterility issue, the implants are still sterile.
Understand that the silicone particles are most likely from production of the implant shell, so there is nothing different about the material in comparison to the implant itself. Cotton lint is something that will occur with any surgery, due to use of sterile cotton towels, gauze, and surgical sponges. After any operation, you would find cotton lint or particles due to the normal course of surgery.
There is no evidence of harm that would be caused by either of these, so the European decision and the FDA decision are just precautionary until this issue is resolved. The regulatory bodies actually have no specific level of surface particles that would trigger any sort of investigation, it is on a case by case decision.

Sientra implant safety

{{ voteCount >= 0 ? '+' + (voteCount + 1) : (voteCount + 1) }}
In the U.S. there is a temporary hold on sales of Sientra implants, they have NOT been discontinued. The issue was what are called contaminants found on the implant surface, not in the silicone gel itself. 
An Australian research group identified these contaminants as probable cotton lint and silicone particles, which is most likely a by-product of the manufacturing process. There is no indication that this is a sterility issue, the implants are still sterile.
Understand that the silicone particles are most likely from production of the implant shell, so there is nothing different about the material in comparison to the implant itself. Cotton lint is something that will occur with any surgery, due to use of sterile cotton towels, gauze, and surgical sponges. After any operation, you would find cotton lint or particles due to the normal course of surgery.
There is no evidence of harm that would be caused by either of these, so the European decision and the FDA decision are just precautionary until this issue is resolved. The regulatory bodies actually have no specific level of surface particles that would trigger any sort of investigation, it is on a case by case decision.

Concerns about the Sientra implants

Sientra distributes Silimed implants in the United States. These implants were withdrawn from the European and Brazilian markets following claims of product contamination. In a proactive and wise move, Sientra has asked it's surgeons not to use these products at this time. It is a noble and appropriate action in keeping with the high ethical standards of the company and it's management. As an occasional user of Sientra, I respect the company and am looking forward to clarification of the problems as the matter is evaluated. There is currently little information as to the type of contamination discovered or where this implants were sent. There is no reason to panic and there is no reasonable need to replace these implants. In time we will all know the details and be able to take appropriate actions.
I use Mentor and Allergan implants (as well as Sientra). The choice is based on which implant serves the needs of my patients best. All of these implants are well constructed and excellent options for surgeons. I used to use Allergan preferentially, now I use Mentor. The technology and implant options only keep getting better.

Concerns about the Sientra implants

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Sientra distributes Silimed implants in the United States. These implants were withdrawn from the European and Brazilian markets following claims of product contamination. In a proactive and wise move, Sientra has asked it's surgeons not to use these products at this time. It is a noble and appropriate action in keeping with the high ethical standards of the company and it's management. As an occasional user of Sientra, I respect the company and am looking forward to clarification of the problems as the matter is evaluated. There is currently little information as to the type of contamination discovered or where this implants were sent. There is no reason to panic and there is no reasonable need to replace these implants. In time we will all know the details and be able to take appropriate actions.
I use Mentor and Allergan implants (as well as Sientra). The choice is based on which implant serves the needs of my patients best. All of these implants are well constructed and excellent options for surgeons. I used to use Allergan preferentially, now I use Mentor. The technology and implant options only keep getting better.

Sientra breast implant sales now DISCONTINUED in the US

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 info@sientra.com, or by calling us at 888.708.0808.
Thank you for your patience, understanding and support throughout this process.

Respectfully,
Hani Zeini
Founder and Chief Executive Officer
Sientra, Inc.

Sientra breast implant sales now DISCONTINUED in the US

{{ voteCount >= 0 ? '+' + (voteCount + 1) : (voteCount + 1) }}
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 info@sientra.com, or by calling us at 888.708.0808.
Thank you for your patience, understanding and support throughout this process.

Respectfully,
Hani Zeini
Founder and Chief Executive Officer
Sientra, Inc.

Big Concern

While the US has not removed the Sientra Implants from the market at this time, I do have significant concerns related to the issues identified in other countries.  Impurities and foreign substances were found in the gel material, according the statement from the Plastic Surgery Society.  At this time, I am not recommending Sientra Implants to my patients until the issue becomes more clear.  Hope this helps.  See if your MD can utilize another Implant company if you have significant concerns.

Big Concern

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While the US has not removed the Sientra Implants from the market at this time, I do have significant concerns related to the issues identified in other countries.  Impurities and foreign substances were found in the gel material, according the statement from the Plastic Surgery Society.  At this time, I am not recommending Sientra Implants to my patients until the issue becomes more clear.  Hope this helps.  See if your MD can utilize another Implant company if you have significant concerns.

According the the FDA the answer is yes

The FDA regulates the approval for the use of medical devices in the USA, and they approve the use of the Sientra implants. If you have the oportunity of examining the characteristics of the silicone used on the three type of implants used in the USA, you could see that the sientra silicone is more cohesive (speaking about the regular silicone implants, not the highly cohesive form stable ones). When I show patients this differnces most patients choose sientra implants. You need to remember that at the end, you as the patient have the right to choose the implant you prefer. In my opinion, your surgeon should give you all the possible information so you can make an INFORMED decision.

Good luck on your surgery

According the the FDA the answer is yes

{{ voteCount >= 0 ? '+' + (voteCount + 1) : (voteCount + 1) }}
The FDA regulates the approval for the use of medical devices in the USA, and they approve the use of the Sientra implants. If you have the oportunity of examining the characteristics of the silicone used on the three type of implants used in the USA, you could see that the sientra silicone is more cohesive (speaking about the regular silicone implants, not the highly cohesive form stable ones). When I show patients this differnces most patients choose sientra implants. You need to remember that at the end, you as the patient have the right to choose the implant you prefer. In my opinion, your surgeon should give you all the possible information so you can make an INFORMED decision.

Good luck on your surgery

From the information we have, yes they're safe

This was an issue identified during production of an implant that is NOT USED in the US. Here is a snipet from the press release:

"The MHRA statement did said however that “for the moment there has been no indication that these issues would pose a threat to the implanted person’s safety.” To date, this issue appears to be of concern outside the United States."

This is nothing like the prior concerns about "industrial grade silicone" that was used in a French implant. I do use Sientra implants and I'm not concerned. I'm sure there will be more information available soon, but I wouldn't change your plans. The other companies are already jumping all over this just to create controversy, but it can just as easily happen to them. 

From the information we have, yes they're safe

{{ voteCount >= 0 ? '+' + (voteCount + 1) : (voteCount + 1) }}
This was an issue identified during production of an implant that is NOT USED in the US. Here is a snipet from the press release:

"The MHRA statement did said however that “for the moment there has been no indication that these issues would pose a threat to the implanted person’s safety.” To date, this issue appears to be of concern outside the United States."

This is nothing like the prior concerns about "industrial grade silicone" that was used in a French implant. I do use Sientra implants and I'm not concerned. I'm sure there will be more information available soon, but I wouldn't change your plans. The other companies are already jumping all over this just to create controversy, but it can just as easily happen to them. 

Sientra Implants Safe?

Right now, the issue is ongoing and there has not been a response by the FDA.  All of the implants are made in two manufacturing plants in Brazil, but Sientra claims that the US implants are separate from the European ones.  However, until the FDA comments on the issue, a cloud will hang over the company.  Currently, the Sientra/ Silimed implants are still available here, but a lot of plastic surgeons will be hesitant to use them until there is more information.

Sientra Implants Safe?

{{ voteCount >= 0 ? '+' + (voteCount + 1) : (voteCount + 1) }}
Right now, the issue is ongoing and there has not been a response by the FDA.  All of the implants are made in two manufacturing plants in Brazil, but Sientra claims that the US implants are separate from the European ones.  However, until the FDA comments on the issue, a cloud will hang over the company.  Currently, the Sientra/ Silimed implants are still available here, but a lot of plastic surgeons will be hesitant to use them until there is more information.

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.