… a new and safer choice for Australian women!
The most significant recent addition to the range of Breast Implants available in Australia is the extensive range of Polyurethane Foam-Covered Silicone Gel Implants. Manufactured in Brazil by Silimed, these implants were approved for use by the Australian Government’s regulatory body, the Therapeutic Goods Administration, in 2008.
Please note that Polyurethane Foam-Covered implants contain cohesive silicone gel like other silicone implants, the only difference being the thin 1mm layer of Polyurethane Foam that is bonded to the implant wall. This layer of Polyurethane Foam gives the implants a “furry” feel – hence their colloquial name “Furry Brazilians”!
The VERY SIGNIFICANT ADVANTAGES of Polyurethane Foam-Covered Silicone Breast Implants is the DRAMATIC reduction of the two commonest complications after Breast Augmentation that would require future revision surgery: Capsular Contracture and Implant Displacement.
Capsular Contracture
Soon after insertion, every breast implant becomes completely surrounded by a soft fibrous envelope called the ‘capsule’. Capsular Contracture occurs when this normally undetectable fibrous envelope undergoes contracture and shrinks in a fashion similar to ‘shrink wrap’. This compresses the implant and so causes the breast to feel firmer, often distorting its shape at the same time. Revision surgery is required to correct this.
Capsular Contracture has been reported to be the commonest reason for repeat surgery after breast augmentation*. The Allergan Core Study in the USA reported in 2008 that 16.8% of women with traditional Smooth or Textured Breast Implants had developed Capsular Contracture within 8 years after their Breast Augmentation.
In contrast, Polyurethane Foam-covered implants have a dramatically lower risk of Capsular Contracture of around 1%. The Polyurethane Foam achieves this by providing a three-dimensional lattice work for the collagen fibres in the capsule to grow into and wrap themselves around the individual strands of Polyurethane. In this way the collagen fibres of the capsule are arranged at different angles to each other and not parallel to each other as occurs with Smooth and Textured Breast Implants. Therefore, there is much less chance of the collagen fibres being able to contract like ‘shrink wrap’.
Hereunder, are just three of many reports on the ability of Polyurethane-Covered Silicone Implants to reduce the risk of post-operative Capsular Contracture:
- Dr Guillermo Vazquez, a Plastic Surgeon in Argentina, reported his experience using these implants in 1,257 patients over an 18 year period. He concluded:
“Polyurethane coated silicone gel implants …. are the best option for augmentation mammoplasty and have the lowest incidence of fibrous Capsular Contraction (1%)”
Source: Vazquez, G. Polyurethane-Coated Silicone Gel Breast Implants Used for 18 years. Aesthetic Plastic Surgery, 2007.
- Dr Neal Handel, an Assistant Clinical Professor of Plastic Surgery in Los Angeles reviewed all of the breast implant patients from his practice covering the period 1981-2004. 345 Smooth Implants, 618 Textured and 568 Polyurethane Foam-Covered Implants had been used. Dr Handel reported:“Based on analysis of our data, we conclude that the contracture rate after all types of breast surgery is dramatically lower with Polyurethane Foam-Covered implants than with Smooth or Textured implants”“There is nothing…to suggest that polyurethane foam, or its in-vivo breakdown products, pose a threat to the health or safety of patients. Polyurethane implants have measurable advantages over Smooth and mechanically Textured gel-filled prostheses and do not appear to be associated with an increased risk of complications or morbidity.”
Source: Handel, N. Long–term safety and efficacy of Polyurethane Foam-Covered Breast Implants. Aesthetic Surgery Journal Vol.26 2006 - Dr Roderick Hester, Dr John Tebbetts and Dr Patrick Maxwell from Georgia, Dallas and Nashville respectively, reviewed the literature on, and their experience with, Polyurethane-Covered breast implants.
The senior author concluded
“During the span of this author’s practice, he has never been able to match the number and quality of superior results exemplified by these patients when using other devices.”
Source: Hester T.R., Tebbbets, J. Maxwell, G.P. The polyurethane-covered mammary prosthesis: Facts and fiction (II). Clinics in Plastic Surgery Vol.28 2001.
Implant Descent & Rotation of ‘Tear Drop’ (Anatomical) Implants
Descent of an implant from its original position, or Rotation of a ‘Tear-Drop’ Implant, will produce a deformity of breast appearance and require revision surgery to return the implant to its original position. The Allergan Core Study reported in 2008 that such implant ‘movements’ make up the SECOND COMMONEST complication requiring revision surgery after Breast Augmentation*. In marked contrast, Polyurethane Foam-Covered Implants, because of their firm adherence to the implant pocket walls, dramatically reduce the chances of implant movement and thus in turn reduce the risk of future revision surgery.
Implant Descent: Should any non-Polyurethane Foam ROUND or ‘TEAR-DROP’ implant descend it will produce a deformed appearance and require further surgery to return the implant to its original position.
Rotation: Understandably, Rotation of a ROUND implant is of no concern because being perfectly rounded, rotation cannot produce any deformity. In contrast, rotation of a ‘TEAR-DROP’ implant WILL produce a deformity and further surgery is required to return the implant to its former position.
The unique advantage of Polyurethane Foam-Covered Implants is that the Polyurethane Foam surface grips to the surrounding capsule like ‘Velcro’ making the risk of rotation or descent extremely unlikely. This translates into a reduced risk of future revision surgery.
Prior to the introduction of Polyurethane Foam-Covered Implants, many patients were wary of choosing ‘Tear-Drop’ Implants because of their inherent risk of rotation – even though they may have preferred the more natural shape they offered over Round Implants.
However, since the introduction of the Polyurethane Foam-Covered implants, more of our patients are choosing ‘Tear-Drop’ over Round Implants because of their very ‘natural’ shape and their negligible risk of rotation.
*Source: Allergan Core Study, 2008
FREQUENTLY ASKED QUESTIONS
Are Polyurethane Foam-Covered Implants New?
They were first introduced in 1970 and have been in use throughout the world ever since. However, they are new to Australia, being approved by Australia’s regulatory body, the Therapeutic Goods Administration, in 2008.
Are They Safe?
Yes. Since their introduction in 1970, there have been more than 60 papers published in learned journals around the world in relation to these implants. These papers have confirmed their safety and reduced rate of Capsular Contracture.
Are They Likely to be Available in the Size and Shape I Want?
Yes. The current range of Silimed Polyurethane-Surface implants is very extensive. Implants are available in many sizes and shapes – round, ‘tear- drop’, conical and oval.
What If My Surgeon Does Not Use These Implants?
Disappointingly, not all Breast Augmentation Surgeons are currently offering patients the choice of Polyurethane Foam-Covered Silicone Implants. Based on the overwhelming evidence on the major advantages of these implants over traditional Smooth and Textured Silicone Implants, Dr Mayson believes that every patient intending to have a Breast Augmentation should at least be given the opportunity of considering the Polyurethane Foam-Covered Silicone Implants. If you find that the surgeon you are seeing does not offer these implants to you as an option, you owe it to yourself to seek a second opinion from one that does.
What Guarantees Are There With Polyurethane Surface Implants?
Silimed offers a lifetime warranty against any rupture of the implant wall. In the event of wall rupture, a new Silimed Polyurethane Silicone Implant will be made available to your surgeon through its Australian Distributor, Device Technologies.
Silimed also offers full implant replacement for up to 10 years in the case of Capsular Contracture (Baker Grade III or IV), implant rotation and implant displacement.
These warranties do not cover the costs of a new operation, but only offer to replace the Polyurethane Implant.
