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 seen 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, dramatically 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.
Any surgical or invasive procedure carries risks. Before proceeding, you should seek a second opinion from an appropriately qualified health practitioner.