Silicone implants and silicone safety

Posted on February 4, 2009

There are 10,000 to 25,000 breast enlargements performed in the United Kingdom every year. The majority of implants used are silicone filled implants.

There were approximately 350,000 breast enlargements performed in the US in 2007. In the US the majority of implants inserted were saline filled implants following the silicone controversy. This is now changing as silicone filled implants are being re-introduced.

This occurred after the FDA in the US looked at the evidence around silicone implant safety and allowed their use again.

The modern silicone breast implant was first manufactured in 1963. All implants have a similar design, an outer silicone elastomer shell, which can be smooth or textured. It can have other variations of size and shape. The shell is then filled either with silicone or with saline.

The choice of implant is particular to each patients need. The modern silicone implant is filled with a cohesive type gel. This is a jelly like consistency so the silicone does not leak when cut.

This type of implant is called a third generation implant as it replaces two previous developments of implant design. This also includes a tougher outer silicone shell which allows much less silicone “bleed” or diffusion as well as being filled with a more viscous and cohesive gel. A cohesive gel minimises gel spread in the case of rupture of the implant.

Silicone and Breast Implants
The basic substance in all implants is silicone gel. Silicone is a polymer of silicon and oxygen. Dimethylsiloxane is the form of silicone found in breast implants. It is one of the least reactive materials used in medical devices.

The shell is made of a tough rubber like silicone. The shell membrane is slightly permeable which gives rise to ‘bleed’. This leakage of silicone should be put into context. Silicone is everywhere in our surroundings from cosmetics to medical devices and may be present already in the body. The two main issues relating to Silicone Implant safety were regarding the risk of breast cancer and connective tissue disease.

Breast Cancer
There is no evidence that silicone causes cancer in humans. Furthermore studies have shown that women with silicone implants have 30% less breast cancer when compared to women without implants.

The idea that breast screening may be impaired by the presence of a breast implant has also been shown not to be true in a number of studies. Mammographic screening should take place as it would with any woman. Mammograms should be performed by a unit experienced in displacement views.

Connective tissue disorders
Studies to date have failed to find a connection with any connective tissue disease and silicone. ‘Despite the many reports in the media, exhaustive evaluations by multiple prestigious scientific bodies such as the Institute of Medicine, the British Ministry of Health, a committee of the European Union (EQUAM), and multiple panels of experts established by various courts have confirmed that no evidence exists of any known or new systemic illness definitively attributed to silicones.’ eMedicine Breast Implants, Silicone: Safety and Efficacy 2005.

Silicone Implants in the United States
In April 1992, the Food and Drug Administration of the USA determined that concerning silicone implants was not sufficient to demonstrate the safety of silicone breast implants. The silicone breast implants were removed from the market.

Following this ruling Mentor Corporation and McGhan (Inamed) carried out a number of studies looking at silicone implant safety. In April 2005, third-generation silicone breast implants were given approval by the FDA for use in reconstructive patients. In 2006 the FDA approved the use of silicone breast implants for cosmetic use.

You and Your Breast Implants
Silicone breast implants continue to be the most popular type of implant used in the United Kingdom for breast enlargement. Discussion with your surgeon is important in making up your mind about whether breast enlargement is right for you. It is also important to discuss with you the type of implant you should use.

Consult Peter Butler’s PIP BREAST IMPLANT ALERT blog for information on PIP implants or find out more by calling 0843 636 8901.

10 Comments

Patrick Mallucci

1st April 2015, 12:00am

Dear Gina,
Thank you for your enquiry regarding the treatment of your capsule. At present non-invasive methods for treatment of capsules are limited and probably useful only for early encapsulation of young implants. Given the age of your implants (1990) it is unlikely that laser would be useful. I also agree that any other manipulation would not be advisable. The best course of action would be to arrange a consultation and to be assessed clinically. It is likely that after such a long period of time you will probably need to have the implants exchanged. I hope the advice has been helpful. Best wishes.

Debby E. Coles

1st April 2015, 12:00am

I had breast implants under Peter Butler at the Marylebone Clinic/Princess Grace Hospital in 2007 (not sure of exact date). Can you please confirm that PIP implants were not used.
Thankyou

Norman Waterhouse

1st April 2015, 12:00am

Dear Debby, I can reassure you that neither Peter Butler nor any other MyBreast surgeon at any time used pip implants. I hope that is helpful.

Melany Dixon

1st April 2015, 12:00am

Hi - I had a my breast implant at BUPA Elland, Nr Halifax approxinmately 4 years ago. There is a lot of controversy on the news about PIP implants. Can you tell me if My Breast have ever used PIP implants and if I should be worried about my breat enlargement?

Kind Regards

Peter Butler

1st April 2015, 12:00am

Dear Melany,
We are unable to comment on operations carried out at specific hospitals however I can assure you that MyBreast have never at any time used pip implants.

wilma campbell

1st April 2015, 12:00am

im a bit confused regarding the time these implants were made and when they were used in the uk.i had my implants done in 2000 and as far as i can see i should be ok ?

Peter Butler

1st April 2015, 12:00am

Dear Wilma, I think to be sure you should definitely contact your surgeon or the hospital where you had your implants carried out. It appears that pip implants, in there initial stages were made with better manufacturing standards and the deviation from these standards has come much more recently than 2000. However, I think if you can contact your provider this would put your mind at rest.

Melly

1st April 2015, 12:00am

Hi,
I had my breast impalnts with MyBreast in Jul 2009 and feel very well, thank you.
My question is - should I avoid using infrared sauna and how it will affect the implants? Is there any temperature range which is harmless, if there is any harm in it?
Thank you. Best Regards

Peter Butler

1st April 2015, 12:00am

Dear Melly, thank you for your question. There is no risk to you using infrared sauna and neither are you likely to experience any problem due to the sort of temperature that is compatible with normal activity. I hope this is helpful.

Gina

1st April 2015, 12:00am

I had silicone implants in 1990 and they are still there and doing great. Only slight problem is that I have had a bit of encapsulation over the last year on the right breast. It is not drastic but it is altering the shape very slightly. I understand there is a new laser process for removing encapsulation, would this be possible for me or are my implants too old? I have been reluctant to use heavy massage to break it down because of the age of the implants.