Polyurethane-Coated Silicone Gel Breast Implants Used for 18 Years- Review of a Study done by Guillermo Vazquez, M.D., and Andrea Pellon, M.D.

Sep 30, 2011 by

Medical paper time. Polyurethane foam covered silicone gel breast implants have been used for 40 years in hundreds of thousands of women around the world; they have been studied a great deal as well. the point of any medical study is to evaluate the effectiveness of a product, is it safe? does it meet the needs of the patient? Simply, does it do what is it supposed to do and not lead to complications?

The interesting part of studies regarding breast implants is they continue to show a local complication rate as high as 15% following primary augmentation- the FDA even states that up to 20% of women will need to have their implants removed within 8-10 years due to local complications. So what are the local complications? capsular contracture, malposition, wrinkling and rippling are all listed.

I do not include “size change” as a local complication, that is simply a desire to change your look. The is not a proven way to avoid future size change- other than conduct a thorough review of your implant size with your doctor.

To a very good, long study: Polyurethane-Coated Silicone Gel Breast Implants Used for 18 Years by Guillermo Vazquez, M.D., and Andrea Pellon, M.D. The entire study can be read here, I will pull out some highlights from the study and findings.

The study was published in 2007, the point of the study:

Abstract. This study aimed to present an update on the use of polyurethane-coated silicone gel breast implants. After 18 years of experience using these implants and 1,257 surgically treated patients, the authors can draw some new conclusions. Their postoperative follow-up evaluation of 300 patients for 5 years, 250 patients for 10 years, and 180 patients for 15 years has shown the lowest incidence of fibrous capsular contraction (1%) with these implants.

This is a very long term study- up to 15 years following patients, that began with large number of patients- 1,257.

Since the study published by Ashley in 1970 on implants coated with polyurethane that have a Y-shaped septum, excellent cosmetic results have been achieved with this type of implant, and the incidence of fibrous capsular contraction has been low. In the years after this study, other reports on the use of these implants were published, and several modifications were introduced with regard to coating, gel density, implant profile, and surgical plane. All such variations resulted in better aesthetic outcomes and better results after mastectomy reconstruction.

Why is this important- it shows how long Polyurethane foam implants have been used and studied- since 1970 and that the Polyurethane foam implants have continued to improve with time and advances in technology and become even better.

In 1994, Bucky concluded that the capsules formed around textured saline implants were significantly firmer and less compliant than those of polyurethane-coated implants. This author further noted that although inflammatory cells were present in the capsules of polyurethane implants, there was less fibrotic tissue and less type 3 collagen than in the capsules of textured implants.

There is more discussion in the full report, but this summarizes the findings regarding why s polyurethane foam covered silicone gel breast implant are more effective than smooth implants or textured implants at reducing capsular contracture and complications- they form a different kind of capsule that does not become firm and hard.

With regard to polyurethane implants, there has been concern about the breakdown products of the material, particularly 2,4-toluenediamine (TDA) [35], which was thought to be potentially carcinogenic. The update published by the Food and Drug Administration (FDA) [15] 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.

In 1997, Hester et al. [23] 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 et al. [33], who stated that 2,4-TDA is not a relevant material with regard to toxicity and carcinogenesis.

Very important, the s polyurethane foam covered silicone gel breast implant are safe.

After using the polyurethane-coated breast implants for 1,257 patients over 18 years, we have reached the

following conclusions:

  • Initially, during the first 6 weeks after surgery, an increase in breast tension is observed. Later, the breasts become softer. This effect increases with time, until their appearance becomes natural.
  • One particular feature is that the implant remains behind the mammary gland and follows it in all its natural movements instead of displacing itself freely throughout the capsular space, as seen with smooth implants and, less often, with textured implants. 
  • In most cases, the polyurethane foam coating begins to disappear about 2 years after surgery. Because the implants currently used have a vulcanized coating, when such coating disappears, the implant behaves as a textured implant. The imprint of the foam on the surface causes a roughness that can be seen macroscopically. 
  • Our studies of the capsule have confirmed that part of the polyurethane remains in the capsule. The capsular microscopic architecture is completely different from that of the capsule of smooth and textured implants because the collagen is not organized in a linear and parallel manner. Rather, its fibers are interwoven. This occurs mainly because there are polyurethane remnants in the capsule.
  • We recommend placing the upper portion of the implant, either the anatomic or rounded model, in a subfascial position. This allows for an adequate dissection plane and a similar thickness in all its extent, thus preventing the appearance of rippling. We are not convinced of the total subfascial plane approach because we believe it offers no advantages in the lower pole. Furthermore, statistics show it does not affect the incidence of capsular contracture.
  • The incision should be closed in an airtight manner in three planes, especially when it is submammary, because it bears much greater pressure due to the weight of the implant.
  • We have observed a lower incidence of complications, especially fibrous capsular contraction and late seroma, than observed with the use of other implants. This lower incidence is due to the special architecture of the capsule that is formed, which results from the presence of the polyurethane in the coating.

Our wide experience shows that although the use of polyurethane-coated silicone gel breast implants can generate some difficulties for insufficiently experienced surgeons in the beginning, if a correct technique is observed, once the learning curve is surpassed, excellent results are achieved, even superior to those achieved with other types of implants. These implants confer greater naturalness to the breast and have a lower incidence of complications. 

Currently, given our wide experience with the use of polyurethane-coated silicone gel implants, we may state they are the best option for augmentation mammoplasty, and have the lowest incidence of fibrous capsular contraction (1%).

Okay, there is a great deal of information and some more technical details about the placement of the implants. The doctors were not paid to do this study and I am not paid by either the doctors or any implant company. The doctors were using Polyurethane foam and conducted a major study to prove what they thought- that s polyurethane foam covered silicone gel breast implant are the best implant for look, natural feel and reduced rate of capsular contracture.

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