Polytech health & aesthetics
A Germany based company.
Types of implant made by Polytech with Microthane® a medical-grade micro-polyurethane foam for low capsular contracture rates and few adverse effects.
Before the company was named Polytech Silimed Europe GMBH
Somewhat confusing in case of problems with the implants,because previous they sold Silimed implants.
Which were sold as made in Germany.
Nowadays Silimed implants are sold by Sientra founded in 2007.
Silimed is a registered trademark of Silimed Indústria de Implantes Ltda in Brazil.
And again confusing they wrote on their site: coupled with Silimed's 33-year successful worldwide manufacturing record.
The Silimed implants sold by Sientra and FDA approved are not covered with polyurethane.
Chemical in polyurethane implants
There is a controversial discussion about a chemical used in polyurethane implants namely 2.4 toluene diamine.
This is what Polytech Health & Aesthetics wrote:
In 1995, the American health authority “Food and Drug Administration” announced that the estimated excess cancer risk due to micropolyurethane-foam covered implants is less than one in one million over a woman’s lifetime.
This figure indicates that there exists no significant danger according to standard risk analysis.
The general risk to suffer from breast cancer is, according to the WHO statistics, one in nine. >>
Manufacturers and plastic surgeons say: It is safe 2009 >>
MHRA concluded that it was carcinogen BUT In 2003, in response to the MDA report, Polytech Silimed provided MHRA with a review ofevidence for a lower, quantifiable rate of capsular contracture with polyurethane-coated breast implants.
The manufacturer claimed that the clinical benefits of these implants therefore outweighed the potential risks.
In 2004 the manufacturer provided additional evidence which they claimed further supported the clinical benefit of these implants.
In January 2005, the manufacturer informed MHRA of their intention to supply MPS mammary implants in the UK.
As the implants are CE marked medical devices, the MHRA accepts that they can legitimately be placed on the UK market,
provided users and potential recipients are appropriately informed about their risks and benefits >>
Carcinogen and mutagen
According NIH Toxnet, TDA is carcinogen and mutagen >>
An interesting fact: When somebody is sensitized to this substance it can not be excluded that it creates an allergic response
at very low dose in future exposure.source TNO Delft
Polyurethane implants cause cancer
Many women complained they experienced problems like infections and pain.
Investigators for the House panel, the Government Operations Subcommittee on Human Resources and Intergovernmental Relations,
estimate that three million American women have breast implants, and that 25 percent of all implants are the kind that are
tied to a cancer risk by the latest findings. Coated With Polyurethane
Studies of the National Cancer Institute in the early 60's showed that TDA causes cancer in one out of six test animals
In 1980, polyurethane foam introduced by Cooper Surgical as a coating for the brand Meme silicone gel implants.
Scotfoam, the supplier of polyurethane, assumed that the foam was used for industrial purposes.
"When it was observed that polyurethane-coated implants have a lower capsular contracture degree, their use became more frequent" >>
Scotfoam, the supplier of polyurethane foam discovered in 1986 for the first time that its industrial chemical was implanted into
the cancer-prone tissues of the female breast.
Scotfoam informs the firm Cooper Surgical that 2-toluene diamine (TDA), the breakdown product in foam,
is not recommended for use in human implants. If substantial amounts of TDA are produced by the chemical breakup
of the polyurethane covering of the breast implant, and then released into the blood,
the result could be an increased risk of cancer for women with implants.
Dr. Pierre Blais: 'Implants - double cancer '
Research chemist Dr. J.J.B. Pierre Blais' worked for the Canadian 'Health Protection Branch' of the Department of
National Health and Welfare, opinion and is a critic of breast implants .
Occording his opinion are the polyurethane foam used in Même implants not suitable for implantation.
Women with such implants can 'double' expect cancer. One by the silicone gel and the other by the foam.
Blais was ordered to destroy his original notes and delete the documents, wich said that polyurethane foam is not suitable for implants.
He also had his concern about the TDA and found the risks to fetuses and breast-feeding infants.
Blais was fired because he kept insisting that the polyurethane foam-coated implants should have been banned of the market. >>
Dr. Blais said that once in the body, the polyurethane coating almost immediately begin to dissolve.
Radiologist Dr. Michael S. Middleton (UC San Diego) stated that it was determined by MRI scans
that 50% of the implants were ruptured, within 10 years after implantation
In the largest cohort study on rupture of implants among 1,300 women, Dr. Michael Middleton found with a MRI an almost
100% rupture for older implants with polyurethane envelopes,
and an average rupture rate of 35% for all implants.
Scientific research Polyurethane >>