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What Do You Think About the Breast Implants Approved by the FDA March 9th 2012 Made by Sientra Silimed?

What Do You Think About the Breat Implants Approved by the FDA March 9th 2012 Made by Sientra Silimed?

Doctor Answers (9)

Sientra Breast Implants offer comparative quality and safety


Sientra breast implants are not new and have been sold around the world for years through the Silimed company. Since they are now FDA-approved, patients can be assured that they are comparable in manufacturing and quality to that of Allergan and Mentor. The only potential advantage that they may bring to the American breast implant market is competition, which may lower the implant price for surgery.

Web reference:

Indianapolis Plastic Surgeon
5.0 out of 5 stars 26 reviews

FDA approval of Sientra (aka Silimed) breast implants


Sientra breast implants are the same implants manufactured in Brazil under the name of Silimed. These implants are heavily used in other counties and have a good track record for safety and efficacy. These implants allow more choices for women seeking reconstructive or aesthetic breast surgery.

Dr Edwards

Web reference:

Las Vegas Plastic Surgeon
5.0 out of 5 stars 8 reviews

Sientra Breast Implants in Austin Texas


I have used Sientra implants for the past 3 months for many breast augmentations and I've been extremely pleased with them, as have my patients.  They are soft and feel and look very natural.  These implants are considered 5th generation gel implants.  The gel inside is high strength and very cohesive, so much so that it's called a 'form stable' implant.  Watch the video to see why.  The implants retain their shape even when displaced under high pressure.  Also, studies demonstrate that these implants may have a lower rate of capsular contracture and a decreased incidence of rippling compared to 4th generation models.  Sientra is the only manufacturer in the world that makes round gummy bear implants and they come in medium and high profile, which mean more choices in tailoring breast augmentation results.

Austin Plastic Surgeon
5.0 out of 5 stars 16 reviews

Sientra Silimed Silicone Implants - another good choice


Sientra breast implants from the Silimed Company  are now available in the USA. Silimed is a Brazilian-based company, which maintains a nationwide network of sales and service throughout the United States. They are a "major player" .are not new . Being FDA-approved means that they are comparable in manufacturing and quality to that of Allergan and Mentor. Competition is great for patients and plastic surgeons in that there are more choices and hopefully the competition will bring down prices. The most important factor is that this company will only sell their implants in the United States to only board certified or eligible plastic surgeons unlike Allergan or Mentor

Here is the basic information available about this implant.

The implants will be available for women at least 22 years old seeking augmentation surgery, and women of any age seeking breast reconstruction surgery.

Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.

This approval introduces a third company into the U.S. breast implant market, which previously consisted only of Allergan and Mentor.

The deputy director for for science at the FDA’s Center for Devices and Radiological Health, Dr. William Maisel, commented that although silicone gel-filled breast implants have demonstrated consistent safety, “It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.”

The approval of these new implants follows a 3-year study involving clinical trials of the implants on 1,788 women.

As a condition of the approval, Sientra will carry out five- and ten-year studies into the long-term health effects of their implants.

Source: FDA – FDA approves new silicone gel-filled breast implant

Web reference:

Orange County Plastic Surgeon
5.0 out of 5 stars 31 reviews

Silimed/Sientra breast implants FDA approval


I have not personally used these implants.  I do believe that since the FDA has approved them this means they have undergone years of intense study and most likely will be comparable to Mentor or Allergan implants, which are FDA approved.

Baltimore Plastic Surgeon
5.0 out of 5 stars 10 reviews

Sientra Implants


I have not personally used these new implants and they have not yet promoted them to my practice. I will be interested to see them and evaluate them personally if I feel they offer an excellent aesthetic, safe and cost effective alternative.  I am currently, however, completely satisfied with my implant options

La Jolla Plastic Surgeon
5.0 out of 5 stars 1 review

New Implants


I have not personally used these implants, but it is significant that the FDA has approved them. This means they have passed years of intense study and undergone rigorous clinical trials. I doubt they offer any advantages over the other implants already available in the U.S., which have also been through the same scrutiny. Most of us have a favorite brand of implant based on years of experience, and if your surgeon favors the new Silimed implants, I'm sure they will be great.

Austin Plastic Surgeon
4.0 out of 5 stars 14 reviews

New breast implants by Sientra a welcome addition


Few of us have any experience with the Silimed breast implant introduced this week by Sientra, though the FDA standard is a hard test to pass, and the implants are a new and safe alternative. We have yet to see the styles, and warranty available and how they match up with what we currently have to offer.

Web reference:

Chicago Plastic Surgeon
4.0 out of 5 stars 25 reviews

Sientra implants approved by the FDA will not change most surgeons recommendations


The approval of Sientra implants is a welcome addition to the choices for patients. However, these implants do not have an established track record in North America and at best will be similar to those that we already feel comfortable with recommending.

The scrutiny that medical devices and particularly breast implants have undergone prior to approval is very detailed. This company must submit the results of surveillance studies and outcomes over the next 10 years in the USA. If you want to be a part of one of these studies then explore around for your options. Otherwise ask your Plastic surgeon what they would recommend from the choices that are available.

Dr. Mosher

Vancouver Plastic Surgeon
4.5 out of 5 stars 5 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.

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