Polytech Breast Implants are manufactured in Germany and have a Lifetime Implant-Exchange Policy.
At Sydney Cosmetic & Plastic Surgery Clinic, we offer all patients a diversity of implant types based on each patient’s individual requirements and personal preferences. Although each of our Surgeons will recommend whichever implant type best meets the needs of every patient, it is our Dr George Mayson that has been one of Australia’s largest users of Polyurethane Foam-Covered Implants since 2010 and within that time has confirmed first-hand the very significant benefits these implants confer as reported in a number of world studies.
Those reported benefits are:
- Dramatic Reduction in the Risk of ‘Capsular Contracture’ – shown to be the commonest reason for repeat surgery.
- Reduced Risk of Implant Rotation & Implant Displacement – other not-uncommon reasons for repeat surgery.
By nature, every type of breast implant within a short time becomes encased in a thin fibrous envelope called a ‘capsule’. Capsular Contracture occurs when this normally undetectable envelope contracts and shrinks in a way similar to ‘shrink wrap’. In its early stages, the Capsular Contracture only makes the breast feel ‘firmer’. However, if the contracture increases, the breast can end up feeling quite hard, be painful and look out of shape.
However, despite those changes, there is no problem with the breast itself or the implant. It’s only the contraction of the capsule around the implant that’s producing the changes. Once the shrunken capsule is surgically removed, the breast will feel as soft as before. Revision surgery to remove the contracted capsule is known as a Capsulectomy.
Capsular Contracture has been reported in many studies to be the commonest reason for repeat surgery after Breast Augmentation. Although the reported incidence of this complication has varied widely between different studies, the large, 10-year multi-centre Allergan Core Study in North America completed in 2010 reported that 19.1% of the women in the Study with traditional Smooth or Textured Breast Implants – which translates into approximately 1 in 5 women – had required repeat surgery for Capsular Contracture within 10 years of their Breast Augmentation.
In contrast, Polyurethane Foam-Covered implants have a dramatically lower risk of Capsular Contracture of around 1% – in other words, 1 in 100 women!
The following are just three reports on the ability of Polyurethane-Covered Implants to dramatically reduce the risk of Capsular Contracture and in turn lower the risk of repeat surgery:
1. 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.
2. Dr Neal Handel, 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”.
Source: Handel, N. Long–term safety and efficacy of Polyurethane Foam-Covered Breast Implants. Aesthetic Surgery Journal Vol.26 2006
3. 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., Tebbetts, J. Maxwell, G.P. The polyurethane-covered mammary prosthesis: Facts and fiction (II). Clinics in Plastic Surgery Vol.28 2001.
Implant Displacement & Rotation of ‘Tear-Drop’ Shaped Implants
With any breast implant:
- Movement of the implant away from its original position (“Displacement”); OR
- Rotation of a ‘Tear-Drop’ shape Implant
will produce a distorted breast shape and require repeat surgery to return the implant to its original position. The Allergan Core Study reported at the 2008-year mark that after Capsular Contracture, Implant Displacements/Implant Rotations with Smooth and Textured Implants were the second commonest reason for repeat surgery. In contrast, Polyurethane Foam-Covered Implants, because of their ‘velcro-like’ adherence to the implant pocket walls, greatly diminish this risk.
Implant Suspensions in 2019
In early 2019, France’s health authority ANSM (Agence Nationale de Securité du Medicaments) suspended various brands of Macro-Textured Implants, including Polytech’s Polyurethane Foam-Covered Silicone Implants, on the basis of a possible link to BIA-ALCL (Breast Implant Associated – Anaplastic Large Cell Lymphoma) – a VERY RARE type of Lymphoma. Australia’s regulatory body, the TGA (Therapeutic Goods Administration), followed suit in October 2019 also suspending a long list of Macro-Textured Implant brands.
Included on the list of TGA-suspended implants were Polytech’s Polyurethane Foam-Covered Silicone Implants. However, these implants are accessible on an individual patient basis under TGA’s Special Access Scheme whereby your Surgeon can apply on your behalf to TGA and seek its approval to use these implants.
For more information on BIA-ALCL click here.
What If My Surgeon Doesn’t Use These Implants?
Currently, not all Breast Augmentation Surgeons in Australia are offering Australian women the opportunity of considering Polyurethane Foam-Covered Silicone Implants because:
- Not all surgeons will admit that the complications of Capsular Contracture and Implant Displacement are far more common with smooth and mechanically-textured implants.
- Polyurethane Foam-Covered Silicone Implants are more time-consuming to insert and require a longer ‘learning curve’ from the surgeon. Accordingly, many surgeons are either unwilling or unable to master the different and subtle techniques these implants require.
- Polyurethane Foam-Covered Silicone Implants cost more and with the current era of discounted breast augmentations, these implants are not being offered by clinics seeking to contain their costs and look more attractive on total price.
Owing to their ability to dramatically reduce the risks of the more common complications after Breast Augmentation that can lead to repeat surgery, Dr Mayson believes that every woman considering Breast Augmentation should at least be offered the Polyurethane Foam-Covered Implants for her consideration.
How you would you feel if your Smooth or Textured implants developed Capsular Contracture, or moved out of position, and you required further surgery at considerable additional cost? And, what if your surgeon had not offered, or even worse, had talked you out of the Polyurethane Foam-Covered Implants which may have prevented your complication?
Accordingly, if you find that the surgeon you are seeing does not offer these implants as a choice, or has limited experience in their use, you owe it to yourself to seek a second opinion from one that does.
Frequently Asked Questions
- They have a thin 1.5-2mm layer of Polyurethane Foam bonded to the surface of the implant shell. It is this thin layer of Foam that gives these implants their ability to dramatically reduce the risks of the commonest complications that lead to repeat surgery.
- Compared to other brands, the silicone gel is very slightly firmer – which we believe is a definite advantage in reducing the risks of visible implant rippling and implant wall rupture.
Polytech is currently the only brand of Polyurethane Foam-Covered Implant available in Australia. In our opinion, they represent high-quality German manufacturing at its best!
- Capsular Contracture
- Implant Displacement or Rotation of a ‘Tear Drop’ Implant
- Over 95% of our Breast Augmentation patients in the period 2010-2018 inclusively have chosen Polyurethane Foam-Covered Silicone Implants.
- In the same period, Dr Mayson has not seen a single case of Capsular Contracture, Implant Displacement or Rotation of a ‘Tear Drop’ Implant with Polyurethane Foam-Covered Implants.
- Dr Mayson is one of Australia’s largest users of these proven-safer implants.
However, compared to the total cost of repeat surgery for a complication that may have been prevented by the use of Polyurethane Foam-Covered Implants, surely the small additional outlay for these implants deserves every patient’s consideration!
- Not all surgeons will admit that complications with Smooth and Textured Implants are more common.
- Polyurethane Foam-Covered Silicone Implants are more difficult and time- consuming to insert and so these implants do not suit surgeons aiming to complete the surgery within a short and set time.
- There is a long ‘learning curve’ required to master the subtle differences in techniques that these implants require and many surgeons are either unwilling or unable to learn these.
- Polyurethane Foam-Covered Implants are more expensive and not an option for clinics discounting their fees to appear more attractive on total price.
How you would you feel if your Smooth or Textured Implants developed Capsular Contracture, or they moved from their original position, and you were then faced with costly repeat surgery after your surgeon had not offered, or even worse, talked you out of them?
Accordingly, if you find that the surgeon you are seeing tries to talk you out of these implants, does not offer them, or has little experience with them – seek a second opinion from one that does!
Any surgical or invasive procedure carries risks. Before proceeding, you should seek a second opinion from an appropriately qualified health practitioner.