PolyTech Silimed Implants - Warning

I came across this letter, from the Medicines and Healthcare products Regulatory Agency, yesterday whilst researching the implants the [clinic] in Prague use and thought that I would make you pre-op ladies aware so if you are considering [the clinic], as I was, then you have another piece of information to help you make your decision. I know its a long letter but the long and short of it is that the implants [the clinic] use have a 'cardinogenic risk'. I've pasted the body of the letter below but if you want to go to it directly the link is:

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I am writing to you about the decision by Polytech Silimed Europe GmbH, to supply their Micro-Polyurethane Surfaced (MPS) mammary implants for use in the UK, as from April 2005.
Polyurethane-coated implants have not been available in the UK since 1991. The purpose of this
letter is to bring to the notice of plastic surgeons the risks and claimed benefits associated with these
implants, so that surgeons can reach an informed judgement on the suitability of the implants and be
able to give appropriate advice to women considering their implantation.

Background

Silicone gel filled breast implants covered with polyurethane foam coating were introduced to
clinical use in the 1970s with the aim of reducing the rate of capsular contracture. They were
withdrawn worldwide in 1991 following concern that the polyurethane coating might release a
carcinogenic breakdown product. One such breast implant (the MPS implant) was subsequently
reintroduced in Europe and the Medical Devices Agency (MDA, now MHRA) issued two Advisory
Notices1 to draw attention to the carcinogenic risk and to advise urgeons that these implants should not be used in the UK.

Evidence of Risk

The carcinogenic risk arising from polyurethane-coated breast implants was assessed by the
Committee on Carcinogenicity2 (COC) in 1991 and 1994. The COC concluded that the implants give rise to a small, unquantifiable carcinogenic risk because the breakdown of the polyurethane coating over a number of years leads to the release of small amounts of the probable genotoxic carcinogen, 2,4-toluenediamine (2,4-TDA). No evidence has emerged since 1994 that would alter the COC’s conclusions.

In 2001, MDA prepared a report on the safety of polyurethane-coated breast implants. This report
presented the opinion of the COC and discussed factors relevant to the carcinogenic risk assessment.

It noted that there were reports of a reduction in capsular contracture with polyurethane-coated breast
implants but insufficient evidence was available at that time to demonstrate the long-term benefits of these devices over other products.

Further Developments

In 2003, in response to the MDA report, Polytech Silimed provided MHRA with a review of evidence 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 November 2003, the above reports were reviewed by the Committee on the Safety of Devices
(CSD). The CSD concluded that, on the basis of the evidence available at that time, the benefits
were not substantial and did not outweigh the remote but unquantifiable carcinogenic risk. They
therefore could not recommend the re-introduction of polyurethane-coated breast implants into
clinical use in the UK. 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.

MHRA has placed details of the CSD discussion and a copy of its 2001 report on the safety of these
implant on its website for the information of plastic surgeons. Information on the benefits claimed
for these implants can be obtained from the manufacturer. Plastic surgeons may also find the
attached information sheet useful when discussing the suitability of these implants with their
patients.

Yours sincerely,

Dr Susanne Ludgate

BSc(Hons) MB ChMB DMRT FRCR FRACR

Clinical Director (Devices)

Medicines and Healthcare products Regulatory Agency (MHRA)

Thats very scary thanks for posting though it will be really useful for any ladies considering them.

x

I was originally booked in with another surgeon who used the Silimed implants. He didn't even advise me of the type of implants he used in the consultation (in fact didn't advise me of much at all in the 10 minutes he spent with me!), I found this out from a member on another forum. It was at this point I started really doing my research and coming onto the forums for advice, as I had been pretty naive to the whole procedure before this. I had a read of this article at the time and made me realise how little I really knew about what I was putting in my body. I don't think the Silimed are too widely used in the UK at the minute, but there are a few surgeons that do use them.

In the end I didn't have a good feeling about the consultation or these implants so decided to go elsewhere and haven't looked back since!

Thanks for sharing the article xx

Thanks for posting lovely

xx

Should help others on their journey!! Thank you for sharing xx

Thanks for posting that, I think I'll stay away from them.

That's scary

Thanks for posting.

Ellie
x

An update on these implants that Happywomble found on the FDA website.

Polyurethane-Coated Implants
About 110,000 women have silicone gel-filled implants with a polyurethane coating, intended to reduce the risk of capsular contracture. In April 1991, an FDA analysis showed that polyurethane foam could break down under human body conditions to form a chemical called TDA, which can cause cancer in animals. As a result, the manufacturer immediately stopped selling the product.
Recently, however, a study to measure TDA in women with polyurethane implants found that a woman's risk of cancer from exposure to TDA released by the implant is negligible--about one in a million over a lifetime. FDA considers it unlikely that even one woman would develop cancer from these implants. The study supports the agency's original recommendation that women who are not having problems should not have the implants removed solely because of concern about cancer from TDA exposure.

So they dont use that type of implant anymore?

Yes they do, I still wouldn't take the chance though.

The FDA has said:

"a study to measure TDA in women with polyurethane implants found that a woman's risk of cancer from exposure to TDA released by the implant is negligible--about one in a million over a lifetime. FDA considers it unlikely that even one woman would develop cancer from these implants."

Also Sarahsbabies, before you post a warning about a clinic, I would advise you to find out IF indeed it is these type of implants the clinic uses as Polytech produces THREE different types of implants:

"The surface of the implant shell is either smooth, textured or covered with a thin layer of Microthane (micropolyurethane foam)."

You dont even know if they use the micropolyurethane ones (I am waiting on confirmation from Laderma regarding same but I certainly wouldn't have posted such a warning before I had the facts). A lot of girls have been to Laderma (including myself) and you should have researched a bit more before posting this "WARNING".

Please keep it calm girls. I appreciate we like to defend our clinics, but please remember to keep it polite.

I have edited out the name of the clinic from the original body of the first post.

When someone can confirm either way which implants with which coating Laderma use I'll re-edit the post

I was not attacking anyone, merely pointing out that when posting a warning, it should be factual. I appreciate Sarahsbabies intentions were good but TDA has been linked to cancer in animals and not humans.

I agree with you on only posting factual information on this forum 100% too otherwise it will be edited, which is has been x

No probs Nads and thanks Mods, it wasn't me defending my clinic, that had nowt to do with it, its just scare mongering if you don't have the facts and a lot of girls have gone to that clinic and I didn't think it was fair to post such a warning and have them worry unnecessarily.

happywomble wrote:No probs Nads and thanks Mods, it wasn't me defending my clinic, that had nowt to do with it, its just scare mongering if you don't have the facts and a lot of girls have gone to that clinic and I didn't think it was fair to post such a warning and have them worry unnecessarily.

I fully appreciate your point happywomble. I have already emailed Laderma myself to see if some clarification can be gained on this point.

Angel x

Me too Angel. And if the FDA are happy enough with the implants (altho they are not FDA recommended, but then again, a lot of implants in the UK are not either), I'm not going to worry.

I'm sorry girls I didn't mean to upset anybody, my intentions were good at the end of the day. I posted the letter I found, I in no way said anybody shouldn't use the clinic, its a personal choice.

Dont worry chick we know your intentions were good, i'm going to lock this post until we recieve confirmation from the clinic x

I thought I would drop a message to say something.
First, Silimed doesn't make Polyurethane-Coated Implants only, and I find it hard to believe that any surgeon would use polyurethane as a regular choice.
At the moment, polyurethane-coated implants have a possible indication in patients with recurrent capsular contracture, as they appear to reduce this risk significantly. The risk of cancer linked to these implants has been measured as negligible, and shouldn't be a reason to avoid them, but I understand that a patient may want to avoid the risk no matter how small.
My last experience with polyurethane covered implants dates back to 1987 or 1988, and it was an implant replacement, so I can confirm that this particular type of implant is much more difficult to remove than ordinary implants... Also, we don't have specific studies on rupture rates, as far as I am aware.
All considered, they are not evil, but there are very few reasons to have polyurethane implants, and almost none if you never had a capsular contracture.

Laderma use textured implants, not the coated ones. I let Nads know this last week. So nobody need fear anything.

Snake wrote:I thought I would drop a message to say something.
First, Silimed doesn't make Polyurethane-Coated Implants only, and I find it hard to believe that any surgeon would use polyurethane as a regular choice.
At the moment, polyurethane-coated implants have a possible indication in patients with recurrent capsular contracture, as they appear to reduce this risk significantly. The risk of cancer linked to these implants has been measured as negligible, and shouldn't be a reason to avoid them, but I understand that a patient may want to avoid the risk no matter how small.
My last experience with polyurethane covered implants dates back to 1987 or 1988, and it was an implant replacement, so I can confirm that this particular type of implant is much more difficult to remove than ordinary implants... Also, we don't have specific studies on rupture rates, as far as I am aware.
All considered, they are not evil, but there are very few reasons to have polyurethane implants, and almost none if you never had a capsular contracture.

Thanks for that Snake, that info is much appreciated

[quote="sarahsbabies"]I came across this letter, from the Medicines and Healthcare products Regulatory Agency, Fact: when your asleep - who knows what kind of implant is being put into your body! I reqested USA FDA approved Allergan implants. That is not what i got!!! The FDA approved one's cost about £600 the Silimed ones cost £150-300.


Don't be fooled ladies as i was - hundreds of clinics in the UK use Coeshive Gel or Coeshive Silicon gel (same thing) most are manufactured by Silimed. This is 101% Correct!!!

Your trusted surgeon will not or may not tell you who makes them, and he will not tell you they are poly coated. Why???? Because there are many cases of patients with problems re: capsular contraction, lymp nodes, tenderness soreness in breasts etc

My surgeon has told me that the silimed implants i have are not poly coated, he says they are silicone coated. Funny!!!! coz i checked Silimed website and it clearly states the main two types which are smooth or textured Polyurethane coated. When i told him this - he went a bit red and acted very sheepish!!!

I spent 2days rearching the subject and found 50 independant research articles on the web re: Toxicity and degradation (out shell breaks down into the body within 2years)

I requested, that he email the company and send me copy stating exactly what kind of implants he used. Since clearly he seemed not to know!!!!