Future of Sientra?

I've been following the turmoil at Sientra and I'd like to get some perspective from doctors most familiar with the products. Silimed, the manufacturer for Sientra, recently had it's CE-Mark certificate suspended due to microscopic particles being found on implants at it's manufacturing facility. The UK halted sales and Sientra then voluntarily stopped selling in the US pending a review by the FDA. Is this discovery of particles of any major concern or is this much to do about nothing?

Doctor Answers 6

Sientra's Future and Breast Implants

Good news.  Sientra is ramping up for sales again.  I anticipate they will be available in the next few weeks.  Most likely in February.  This is based on what I hear and read.  Let's hope so because this is a great product.  None of the implants that I have placed over the last year and half have had a problem and they have all been Sientra implants.

I hope that helps.  

Best regards.

Kirkland Plastic Surgeon
4.9 out of 5 stars 64 reviews

Turmoil at Silimed/ Sientra

I like the variety and quality of the product.  I'm concerned about the future of the company.  One of the Brazilian factories burned down, and the CEO of Sientra, Hani Zeini, resigned.  I have heard rumours of an SEC lawsuit.

D`Arcy Honeycutt, MD
Bismarck Plastic Surgeon
4.7 out of 5 stars 23 reviews

Future of Sientra?

Excellent question and it is difficult to know what will take place with Sientra as the sole distributor of Slimed products, in addition to the current lawsuit against the company.  Taking guidance from the governing body of plastic surgery, there is a moratorium on the future use of Sientra products until an appropriate investigation reveals that the products are safe to continue to use, or will need to be permanently removed.  The implants are an excellent product and colleagues I spoke with have not seen issues with them, but it is of course best to be safe.  

Nelson Castillo, MD
Atlanta Plastic Surgeon
4.9 out of 5 stars 68 reviews

It's rough sailing right now, but should be fine...

There certainly is a lot of drama right now, but I do like the product!  We are hoping to get some implants back by January.  It would be a shame if they were sold, but that could happen too.

Robert S. Houser, DO
Columbus Plastic Surgeon
5.0 out of 5 stars 15 reviews

Sientra Breast Implants

Sientra is the US distributor for Silimed breast implants that are made in Brazil. To my knowledge, there are no tolerance levels for microscopic particles on the surface of breast implants as it relates to a CE mark in the EU. We also do not know what level if any microscopic particles exist on the implants that remain on the market here in the United States from Mentor and Allergan. As far as we are being told by Sientra, these sterile microscopic particles pose no health risk to our patients and there's certainly no data out there to suggest otherwise. I'm hopeful that when this whole process works its way through the FDA Sientra implants will again be available in the US.

Marc J. Salzman, MD, FACS
Louisville Plastic Surgeon
4.7 out of 5 stars 54 reviews

Future of Sientra

Sientra makes an excellent implant.  The company is keeping us up to date on any new developments.  

Robert E. Zaworski, MD
Atlanta Plastic Surgeon
4.8 out of 5 stars 62 reviews

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.