Polyurethane breast implants

09 January 2018

Dear Clinic,

I am ready for the breast augmentation operation this week with dr. Pataki. I was very satisfied with all the consultation and you assistants have answered all question. Sorry that I had so many. I think this operation is for a lifetime. I think almost all questions are answered, but one:

To how many people has the doc used polyurethane implants? What is his opinion about those and the possible disadvantages, as I found in various articles online- see below?

"Polyurethane implants have not been reintroduced in the US since their discontinuation in 1992. Studies have shown potential toxicity with polyurethane."
"The UK has issued a notice to its plastic surgeons to not use these implants."
"Polyurethane does tend to fragment and can make it hard to remove implants in the future."

At the same time, I also read other articles that focus on the advantages of those (Capsular contracture & rotation).
"Polyurethane implants have their advantages and disadvantages, with the advantages in the right patient far outweighing the latter."

This makes me a bit worried, so I'd like Mr Pataki's opinion on that. Obviously, I don't think he would recommend something he is not sure of, but still, I'd need his confirmation, as the fact that it is not approved or recommended in some countries is a bit worrying.

(Maybe I should just stop researching!)

Also, the size would be either 375 or 400, right?

Thanks and have a nice day,

Venus


PMA

Dear Venus,

Thank you for your question.  After having a conversation with dr. Pataki, here we come with some short answers to your questions:

“I think almost all questions are answered, but one:” To how many people has the doc used polyurethane implants? What is his opinion about those and the possible disadvantages, as I found in various articles online- see below?
Dr. Pataki has performed many hundreds of breast augmentations with polyurethane implants in Premium Plastic Surgery. We have first used them in secondary, tertiary cases after severe capsular contractures. Dr Pataki used the first anatomical shaped PU covered double gel implant of Polytech (4Two). Then we started to use them in primary cases too. It was proven, that the incidence of contracture developing is lower with the use of textured implants, submuscular placement and the use of polyurethane coated implants. We have done accooringly, which have proved to be good among our patients too.
We stated that “Polyurethane” was a wonderful improvement resulting in breasts (implants) that stay soft and natural. Our Hungarian experience shows that although the use of polyurethane-coated silicone gel breast implants can generate some difficulties for insufficiently experienced surgeons in the beginning of the learning curve, once a correct technique is learned and the learning curve is surpassed, excellent results can be achieved, even sometimes superior to those achieved with other types of implants. These implants confer greater naturalness to the breast (shape) and have a lower incidence of complications in the literature. Recently, given our experience with the use of polyurethane-coated silicone gel implants, we may state they are one of the best option for augmentation mammoplasty, and have the lowest incidence of fibrous capsular contraction (1%). This lower incidence is due to the special bio-imitating architecture of the capsule, that is formed, which results from the presence of the polyurethane in the coating and nothing else. There is no relevant risk in regard to toxicity and carcinogenesis (please see in detail below.)

“Polyurethane implants have not been reintroduced in the US since their discontinuation in 1992. Studies have shown potential toxicity with polyurethane.”
With regard to polyurethane implants in the late 80’s there has been concern about the breakdown products of the material, particularly 2,4-toluenediamine (TDA), which was thought to be potentially carcinogenic. The surgeons who used these implants liked them. But subsequent to the silicone implant moratorium in 1991, they ceased to be available. The update published by the Food and Drug Administration (FDA) in 1995 made it clear, that these implants were safe, because it found extremely low concentrations of TDA (parts per million) in the urine of patients, who had received the implants and those who had not received them (control group). No free TDA was found in the blood of implanted patients. (This is important !) In 1997, Hester published a paper in Plastic Reconstructive Surgery (PRS) regarding TDA, which the FDA took as a reference. The conclusions of the FDA were definitely confirmed by Santerre, who stated, that 2,4-TDA is not a relevant material with regard to toxicity and carcinogenesis.

“The UK has issued a notice to its plastic surgeons to not use these implants.” “Polyurethane does tend to fragment and can make it hard to remove implants in the future.”
The statement is not true anymore. UK follows European guidelines where, PU implants of Polytech Germany are CE labeled, therefor free to use for medical reasons. That statement above is from the early 90’s. PU covered implants are well available in the UK. The defragmentation occured in products of the 80’s. Now 40 years later the industry produces PU coverage, which does not defragment. Today according to my oppinion shear or stress on the cover can not cause the polyurethane to separate from the surface and the implant withstands rotation or disposition and performes very well under stress. With enough experience -I can assure you-, that the statment, that it is very hard to remove PU implants is fals.

“At the same time, I also read other articles that focus on the advantages of those (Capsular contracture & rotation).”
The incidence of capsular contracture is dramatically lower with polyurethane foam-covered implants compared to smooth or mechanically textured implants. This beneficial effect persists at least 10 years after implantation. In studies aside from a transient skin rash, there was no increase in morbidity or complications associated with polyurethane implants. Polyurethane coated breast implants provide low capsular contracture incidence rates. Capsular contracture is the (or one of the) biggest secondary disadvantage of breast implant with a rate of 1-20 percent in the literature. New management strategies or prophylactic strategies attempt to stop capsular contracture before it begins. Of these, the use of acellular dermal matrices has received the most attention, but new research looking at autologous fat transfer or using implants with lower incidence rates such as those coated in polyurethane shows promising results. We therefore use PU covered implants and fat transfer in severe secondary cases (implant exchanges).

“Polyurethane implants have their advantages and disadvantages, with the advantages in the right patient far outweighing the latter.”
It is true.:)

The above makes me a bit worried, so I’d like Mr Pataki’s opinion on that. Obviously, I don’t think he would recommend something he is not sure of, but still, I’d need his confirmation, as the fact that it is not approved or recommended in some countries is a bit worrying.
Thank you. I would certainly not recommend anything I don’t trust. Concerning the ban: it is only valid in the US, becouse of their specific system and very strict regulations. It was not reintroduced in the US. Yet. I think it will be. I always remember what dr. Jack Fisher (Former President of the American Society for Aesthetic Plastic Surgery ) was saying to me at a personal conversation at tha ISAPS congress in Rio couple of years ago. Answering my question, about what he would use as a young European plastic surgeon he said: “my best and longest lasting results in breast augmentation were achieved with polyurethan implants”. He certainly had enourmous experience in primary and secondary mammaplasties. He had access to PU implants in normal cases till 92. With improvements of these implants in the past 20 years we together hope, that polyurethane implants are coming back on the market in the US too. But it also depends on the producer : I had the chance to ask Polytech leaders concerning the “reintroduction” of their PU covered implants to the States. The aswer was: at this point in time the costs of submitting these or any of their implants to the FDA is not justified by the percieved market. (There is a huge Domination of American Allergan and Mentor products) It seems therefore, that no manufacturer has an interest in resurrecting this implant.

(Maybe I should just stop researching!)
Maybe 🙂

Also, the size would be either 375 or 400, right?
The size range is between 375cc and 400cc. After placement of sizers we will fine adjust the final size in the given range.

Other details concerning your operation we will send you through an other email attached.

Please feel free to ask anything if yet questions arise.

Thanks and have a nice day,

Rita and Zita

Assistant to Dr. Greg Pataki

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