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

Question

Joe Gryskiewicz, MD, FACS · Answer

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”

Richard H. Tholen, MD, FACS · Answer

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

Cynthia L. Mizgala, MD · Answer

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.

Adolfo Sesto, MD · Answer

"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.

Jaime Campos Leon, MD · Answer

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

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

Answers (6)

Answer: Polyurethane Implants (PURE IMPLANTS)

Answer: Polyurethane Implants (PURE IMPLANTS)

Answer: Implants

Answer: Implants

Recommended reading

Everything you need to know about Sientra Breast Implants

Our mission is to create a world where every investment in modern beauty is Worth It.

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

Answers (6)

Answer: Polyurethane Implants (PURE IMPLANTS)

Answer: Polyurethane Implants (PURE IMPLANTS)

Answer: Implants

Answer: Implants

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Recommended reading

Everything you need to know about Sientra Breast Implants

Our mission is to create a world where every investment in modern beauty is Worth It.