Are Silimed polyurethane coated "gummy bear" implants more safe ?

Question

Are silimed polyurethane coated "gummy bear" implants more safe ? Does the coating not leak into the skin? I've heard of many problems...has there really been enough testing and how long are they on the market?

Alejandro Nogueira, MD · Answer

These popularly called furry brazilians are implants of cohesive gel filler (gummy bear), anatomical, conical or round shapes, multilayer shell and an outer cover of polyurethane foam.This polyurethane coat provides two specific features making this model one out of the pack:-resistance to capsular contracture in recurrent cases of capsulation-highest adherence in the market, they make a bio velcro, making them essential in cases like tuberous breasts, bottom out, excessive mobility of implants, ex-obese patients, symmastias, etcThey are used safely worlwide 35 years ago, and are approved to use by the most prestigious medical agencies inthe world (UK, Australia, all European Union countries, Latin America, etc), however for some strange reason not in the US by the FDA.My practice is in Spain and I am using them many years ago in those technically risky or challenging cases, with the highest success and patients satisfaction.For those my respectable and reputed colleagues saying that these implants produce problems, let me remind them that deffamation can cause a law suit against them for providing intentionally false information against a brand or product, there is no scientific evidence of any toxicity in humans, and even the FDA issued a note admitting this; the fact that a model is not approved in the FDA territory does not make it unsafe; many brands and models are not approved nowadays in the FDA US area but are used safely worldwide, is the rest of the world wrong? I am sad to read many of your comments, with subtle but unacceptable falseness. Could you clearly say which problems do they produce? Sales of polyrethane breast implants are massive worldwide, millions of women wear them 35 years ago, and 2 manufacturers (Silimed in Brazil and Polytech in Germany) produce them.Let me remind you that:-it was not until 2012 when silicone gel filled implants of anatomical shape were approved in the FDA, were they unsafe due to this reason prior to 2012? -Sientra is not exactly a manufacturer, it is a BRAND, the implants are SILIMED, made in Brazil and later on rebranded and packaged as Sientra for the US market, why do you issue false information; in plain terms: Sientra = Silimed, being Silimed-Sientra the FIRST brand to obtain FDA approval in the history for selling gummy bear anatomical breast implantsYou all should be very very careful with your public opinions, one day someone may get very angry to read lies about its products.

Robert Singer, MD · Answer

Polyurethane implants are not FDA approved for use in the United States and should not be utilized by any surgeon in the United States. The implants that are FDA approved are: Sientra, Mentor, and Allergen.I would
suggest you find a plastic surgeon certified by the American Board of Plastic
Surgery and ideally a member of the American Society for Aesthetic Plastic
Surgery (ASAPS) that you trust and are comfortable with. You should discuss
your concerns with that surgeon in person.

Robert Singer, MD FACS

La Jolla, California

Dustin L. Reid, MD · Answer

These implants were used in the past in the US but had problems.  They are not FDA approved for use in the US and should be avoided.

Tracy Pfeifer, MD · Answer

Thank you for your question.  Implants with a polyurethane shell are not approved for use in the United States.  They are used by plastic surgeons oversees.  In the US, there are concerns that the polyurethane will degrade into toluene, which is a carcinogen (causes cancer) in some studies.  In the US implants can be smooth or textured surface.  The texture does not contain polyurethane.  Textured implants have some advantages over smooth surface implants.  Hope this helps.Tracy Pfeifer, MD, MS

Khashayar Mohebali, MD, FACS · Answer

The implants you are referencing are not approved by the FDA for use in the United States and have a history of problems in the past.  They are not used for any surgery here and you would need to go to another country to get them which I don't recommend.There are many currently approved options in the US to choose from.

Are Silimed polyurethane coated "gummy bear" implants more safe ?

Answers (8)

Answer: Polyurethane coated implants not approved for use in the United States

Answer: Polyurethane coated implants not approved for use in the United States

Answer: Implant options

Answer: Implant options

Recommended reading

Everything you need to know about Breast Implants

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

Are Silimed polyurethane coated "gummy bear" implants more safe ?

Answers (8)

Answer: Polyurethane coated implants not approved for use in the United States

Answer: Polyurethane coated implants not approved for use in the United States

Answer: Implant options

Answer: Implant options

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Recommended reading

Everything you need to know about Breast Implants

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