July 2008

This month, Peter Butler discusses -

Silicone. Is it safe?

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Silicone Implants and Silicone Safety
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 there 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. You can see this demonstrated on the following video clip.
http://www.youtube.com/watch?v=ESdBHUQkbFE
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 minimizes gel spread in the case of rupture of the implant.

 

Silicone and Silicone 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 Silicone Implants
Silicone 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.

6 responses to Silicone. Is it safe?

  1. MB says: September 5th, 2008 at 7:54 am

    I am almost 6 months post op and very pleased with the results of my augmentation but a bit worried about follow up. I am worried about rupture, how will I know when it happens? I read on a website that it is recommended that we have an MRI scan every few years to check for ‘rupture and leakage because the silicone can spread to lungs and lymph nodes’… this is frightening for me. I have an appointment coming up in two weeks, could I ask my surgeon to scan me???

    Reply to this comment

  2. Peter Butler says: October 22nd, 2008 at 1:14 pm

    @MB:
    If there is a change in the implant following surgery then a scan is advisable. An ultrasound scan is what I recommend. This can usually tell if there is a problem with the implant. An MRI scan can also be used but I only use this in occasional circumstances.

    Problems such as a rupture are very uncommon in the first ten years following surgery. If every thing is unchanged I do not recommend any investigation.
    The silicone implant has a life span and with time the implant has an increased chance of rupture. The modern implant is filled with cohesive gel which has a jelly like consistency. This ensures that even if the outer shell of the implant ruptures, the silicone will not leak. See the implant safety video here:

    http://www.mybreast.org/myimplants/is-silicone-safe/implant-safety-video

    I advise that you see your surgeon if there is a change and he or she can advise on further management.

    Reply to this comment

  3. Michele Nardell says: November 3rd, 2008 at 12:11 pm

    I have suffered from high blood pressure ever since having my son 2 years ago and am on BP medication for this. Does this mean I would not be able to have a breast enlargement operation? My blood pressure averages 140/90 on meds.

    Reply to this comment

  4. Zoe says: November 3rd, 2008 at 2:41 pm

    I am looking into having breast implants, but i am worried about the amount of time they will take to heal - could you advise me on this please, as i work within the prison service and would need to let them know how much holiday i would require to use.
    Also, i have just had my 1st child 16 weeks ago and i am hoping next year to have another. Would you advise me to have this surgery after having a 2nd child? Or in your opinion, would this not be an issue? (it does not bother me if i breast feed or not!)
    Many Thanks
    Zoe

    Reply to this comment

  5. Peter Butler says: November 4th, 2008 at 9:58 am

    @Zoe: The recovery period is different for each individual however general recommended time is 2-3 weeks of surgery. Also it is usually best recommended to have your surgery after you have completed your family as your breast will change shape.

    Reply to this comment

  6. Peter Butler says: November 6th, 2008 at 11:57 am

    High blood pressure or hypertension is usually investigated by your G.P. and depending on the cause can be controlled with medication. I would suggest this is something that your Mybreast surgeon could advise on and potentially seek an anaesthetic opinion when you are seen.

    Reply to this comment

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