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Has anyone heard of Pure Implants? Are they FDA approve in CA?

Doctor Answers 6

September 15th, 2015

Polyurethane implants

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The polyurethane coating around silicone breast implants was the issue that caused the FDA such concern in the 1990's and eventually led to a moratorium on all silicone gel breast implant devices. I would definitely recommend choosing an implant that is FDA approved in the United States. There are many great options by Allergan, Mentor, and Sientra.

Learn more: http://www.awomanplasticsurgeon.com/breast/about-breast-implant-surgery

Cynthia L. Mizgala, MD
August 2nd, 2014

Sientra Breast Implants

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Hi Meshell,
The FDA has not cleared these implants for the U.S.  I wouldn't travel to get them, as there are many specific choices available in the states.  Sientra only sells to BC plastic surgeons (by ABPS - The American Board of Plastic Surgery) who are members of ASAPS (The American Society for Aesthetic Plastic Surgery) and or a member of ASPS (The American Society of Plastic Surgeons). Recently approved by the FDA, Sientra (Silimed Corporation) silicone shaped implants are now available for use in the United States. These implants have been used extensively in Europe and South America for 33 years of safety, quality and patient satisfaction. They have round implants (with or without texture), and also shaped implants which can provide a nice "tear-drop" shape for women who want a very natural and "athletic" look. Also, ask if your potential PS has an established, high volume breast augmentation practice, performing several hundred breast augmentations each year. Ask to see their before and after photos if you didn’t see any on their website. If they are experienced, they should have several 100 breast implant patients for you to view. I would also recommend that your doctor offer you the chance to talk to past patients who would be happy to discuss their experience with you. You need to feel comfortable, so make sure the environment is safe as in an accredited surgery center. Also, ask a prospective surgeon if he or she has ever published journal articles in professional peer-reviewed journals, which they can provide you.   All the best, “Dr. Joe”

Learn more: http://c1-preview.prosites.com/25164/wy/docs/ASJ%20Published%20Quick%20Recovery.pdf

Joe Gryskiewicz, MD, FACS
June 6th, 2014

Polyurethane Implants (PURE IMPLANTS)

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"Polyurethane Implants" have been in use for many years here in Dominican Republic under the brand name of SIlimed from Brasil (the manufacturer of the SIENTRA implants approved by the FDA). I have a lot  of experience with them.

I use them in very specific cases where the implant needs to be placed over the pectoral muscle.

If the case allows I prefer the Sientra Cohesive Gel Silicone under the muscle, but if needed I use the Polyurethane ones.


Adolfo Sesto, MD

Adolfo Sesto, MD
Dominican Republic Plastic Surgeon
5.0 out of 5 stars 48 reviews

January 10th, 2014

Implants

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Thank you for the question.


Although these implants might not be available in California, many of these brands are available in different parts of the world.

Dr. Campos
Jaime Campos Leon, MD
January 8th, 2014

Some of the Pure Implants appear to be marketed by Sientra in the USA.

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Greetings,

Sientra, which is the newest FDA approved implant company in the US, appears to use Silimed implants from Brazil.  

Pure–Polyurethane breast implants (made by Silimed in Brazil) are not approved for use by the FDA.    30 years ago, there was a polyurethane breast implant (MEME) which had issues of polyurethane layer separation from the implant (the FDA has not yet allowed the return of this kind of implant).

True Texture implants manufactured by Silimed and sold by Sientra are available in the US market. The textured surface of this implant is an integral part of the shell and allows tissue ingrowth without the risk if separation of the textured surface.

I can not speculate about the availability of breast implants in the Canadian marketplace. I highly recommend that you contact Health Canada through the government website listed below.

Best Regards,

Learn more: http://www.hc-sc.gc.ca/contact/index-eng.php

Douglas J. Raskin, MD

Douglas J. Raskin, MD
Colorado Springs Plastic Surgeon
4.9 out of 5 stars 66 reviews

January 6th, 2014

Pure implants are not available in CA (or USA).

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Pure brand implants are polyurethane implants produced by Sientra, the third company to receive FDA clearance to market their cohesive silicone gel implants (but NOT their polyurethane ones) in the USA.

Polyurethane implants have not been used in the US since 1991, when the FDA restricted the use of silicone gel implants, and all but two implant manufacturers (Mentor, and McGhan, now Allergan) went bankrupt or stopped their US sales. This included many lesser-used implants such as polyurethane, Misti-gold, Dual-lumen silicone/saline, etc. But many countries throughout the world still have the availability of polyurethane implants, which did reduce the incidence of capsular contracture (CC), particularly when used above the muscle, as most breast augmentations were done before the early 1990's.

When Sientra received FDA clearance for the use of its Silimed line of breast implants in the USA in March, 2012, this approval was not for other implants Sientra produced worldwide since 1978. This includes Pure or any other type of polyurethane implant.

The success of polyurethane textured implants minimizing capsular contracture is what led implant manufacturers to develop silicone gel surface texturing in the late 1980's. That, and some bad press about toluene-2,4-diamine (used in the production of toluene diisocyanate, which is used in the production of polyurethane) being a potential carcinogen caused polyurethane to fall out of favor in the US. And, the polyurethane coating seemed to break down after several years, perhaps losing its CC protectiveness. Despite these really ending up being red herrings, polyurethane was never re-studied for FDA re-approval in the US and remains available only outside the US.

I hope this helps. You have many alternatives; speak with your ABPS-certified plastic surgeon; he or she really can tell you about the superior implants presently available. Best wishes! Dr. Tholen

Learn more: http://www.realself.com/article/dr-tholens-comprehensive-guide-breast-augmentation

Richard H. Tholen, MD, FACS

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.