Why Are Polyurethane-covered Silicone Implants Not Legal in USA? Q & A

Nov 22, 2011 by

I will try to avoid ranting and raving about one country not approving a drug/device while other major countries use the drug/device with great success. I will try. But, it still makes no sense to me that capsular contracture in the USA is shown in FDA studies to be up to 15% of implants with textured or smooth shells and the FDA doesn’t evaluate what 35 other countries are using- polyurethane foam covered silicone gel breast implants- to reduce capsular contracture.

This might become a challenge for doctors in the USA as more and more patients know about capsular contracture and polyurethane foam covered silicone gel breast implants- will USA based doctors lose business to countries like England, Brazil and Mexico?

I found this Q & A on the Real Self website (this is a great website for Q & A sessions with doctors) that has some good answers from doctors about why polyurethane foam covered silicone gel breast implants are not available in the USA. I am not including all answers- only the answers that I can verify are correct (one answer is HORRIBLY wrong), please visit the Real Self article for a full read.

The question: Why Are Polyurethane-covered Silicone Implants Not Legal in the USA?

Answers:

Polyurethane covered breast implants became available about 1980 in the US and in our practice at the time we used quite a number of them. The structure of the implant was similar to a regular silicone gel implant, though on the cover a coating of polyurethane was applied much like a textured surface. Capsule contracture had been, and still is, such a problem with subglandular breast augmentation with a silicone gel implant that the polyurethane coating was a very attractive advantage, and the implants worked quite well.

The implant we used at the time was called the Meme implant, and all silicone gel implants including the Meme were withdrawn with the silicone “controversy” in the 1990’s. One drawback to the polyurethane implant was that the texture required a larger incision to properly place the implant, usually inframammary, however we no longer were plagued by firm breasts and needed closed capsulotomy which was so common at that time. With the silicone moratorium all gels were no longer available until replacements were allowed, but still no polyurethane.

Polyurethane was a wonderful improvement with implants that stayed soft and natural, until of course the silicone rubber cover leaked, and than capsules begin to form and the implant is in need of replacement. There are two hurdles to overcome before we may again see this implant in the US. The first thing we learned was that shear or stress on the cover can cause the polyurethane to separate from the surface, not what is intended, though the implant still performed well. The second issue is that as we removed and replaced the implants we found the polyurethane disappears over time. Where it goes and what effects it might cause will take many years of study to answer.

The fact that we are again noticing an interest in using polyurethane implants should remind us of the real problem of capsule contracture with silicone gel breast implants.

Best of luck,

peterejohnsonmd

Furry Brazilian Comment: this is a great answer. The reader can understand the long history of Polyurethane Foam implants and that the implants were withdrawn from the market (not recalled). This doctor found the benefits of Polyurethane foam- soft and natural. The doctor raises valid points regarding Polyurethane disappearing and what happens to the Polyurethane, this has been addressed in studies and is no a concern at this time. I like the last sentence regarding the “real problem of capsular contracture with silicone gel breast implants.” This doctor fully understands that capsular contracture continues to affect a large number (15 out of 100) women.

Compare the answer above to this answer:

Thanks for your question – In addition to the comments posted regarding the uncertainty of the safety of polyurethane implants, significant steps have been made since they’re availability to reduce capsular contracture in the currently available implants including placement, triple antibiotic irrigation, minimizing handling, etc. With improvements in the capsular contracture rate that has dis-incentivized these implants coming back on the market.

Furry Brazilian Comment: ummm, what? I think this doctor might specialize in face or liposuction, or maybe he should. This sounds like one of those doctors that says “my patients don’t get capsular contracture” and has no response to the FDA reports showing capsular contracture in up to 15% of patients within 7 years and have no explanation for the FDA’s consumer brochure stating that up to 20% of implants will need to be removed in 8-10 years and listing capsular contracture as the leading reason. It amazes me this doctor thinks solving capsular contracture is as “simple” as placement, irrigation and handling….those are the *basics* that should be performed, not some new solution to a problem like capsular contracture that has been going on for over 30 years.

The surgeons who used these implants liked them. But subsequent to the silicone implant moratorium in 91, they ceased to be available. At this point in time the costs of submitting these implants to the FDA is not justified by the percieved market. Therefore, no manufacturer has an interest in resurrecting this implant. Despite, their popularity, many questions about the fate and consequences of the polyurethrane remain unanswered.

Furry Brazilian Comment: Agree, the cost of FDA trials and approval will be over US$10 million. Data from other countries (UK, Australia, Germany etc) cannot be used. Sad, but true. And the questions can be answered by looking at the usage and data from other countries.

FDA approval is a long process. These implants were available in the 1980’s in the US. Plastic surgeons who used them were very pleased with the result and the decreased incidence of capsular contraction. The polyurethane layer is usually gone by 10-15 years and following that the incidence of capsular contraction is the same. There was some reports regarding the degradation product of the polyurethane. I met with the CEO of the Silimed company some 5 years ago. At that time they were in the process of applying for FDA approval. As of this year, it is not approved yet.

Furry Brazilian Comment: Again, more about the business of approval than the business of solution. This answer is another statement detailing how much surgeons like the implants when they were available in the USA- surgeons in the 35 countries that currently use polyurethane foam covered silicone gel breast implant- and have been using them for years and years- feel the same way- “very pleased.”

As always my disclaimer- I do not know any of these doctors and am not compensated by the doctors, the website I link to or any implant companies. I encourage you to read the entire posting and continue to read and research. After reading and researching, I am confident you will understand why a Polyurethane foam covered implant is a better, safer option than a textured or smooth implant.

1 Comment

  1. Well said. Appreciate your comments.

    peterejohnsonmd

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