Silicone Implants And Silicone Safety By Peter Butler

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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 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. Click here to see a video of this demonstrated.

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.

Find out more about Breast Enlargement at Mybreast

PIP Breast Implant Alert

A. The Statement from the MHRA and the background

You may have read about the recent PIP implant alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA of the United Kingdom was advised by the regulatory authority in France (AFSSAPS) that on Tuesday 30 March 2010 it suspended the marketing, distribution, export and use of silicone gel filled breast implants manufactured by PIP (a French breast implant manufacturer, Poly Implant Prothese). It has recalled all of these devices.

The MHRA is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
The AFSSAPS recently carried out an inspection of the PIP manufacturing plant and established that most breast implants manufactured by the company since 2001 have been filled with an unapproved silicone gel composition. This is thought to increase its likelihood of leak. It is not known if this affects the safety of the
PIP implants.

The MHRA will provide further advice on patient management, as necessary, when more information is available.

B. What is the current advice and what does it mean in practical terms

The statement explains that the filling gel for these implants was NOT the filling gel that the company applied for a licence to use.
This is clearly of great concern, however at this stage there is no suggestion that it represents a health risk to patients.

So, what should you do?

For MyBreast patients.

At MyBreast we have never used PIP implants, so there is no need for you to be concerned.

For all other Patients

1.    If you have had a PIP breast implant implanted since 2001 you should consult a surgeon.
2.    Your surgeon should have provided you with documentation of the type and make of implant used at the time of surgery, if you have lost this your surgeon should be able to provide details.
3.    If you do not know the make of implant that has been used, you should find out from your surgeon.
4.    If you have had any other breast implant used do not worry, there is NOT a problem with implants produced by other manufacturers.
5.    If you cannot contact your surgeon or do not have the details of your previous surgeon, and would like to discuss things further MyBreast will offer a free consultation to provide advice.

For patients known to have a PIP implants

1.    If there is no sign of implant rupture, then the current advice is that removal is not required at this stage
2.    If there were a sign of implant rupture then, as with any breast implant, it would be sensible to undergo explantation.
3.    The French authorities and the MHRA are continuing to investigate this problem and will provide more information when it is available- we will update this blog as soon as any further information is published.
4.    The PIP implant was always considered an inferior quality implant, and one that was prone to rupture, we have previously had to remove a number of these implants for patients who originally underwent implantation elsewhere. If you had a PIP implant removed in the past, at this stage, there is no need to be concerned

For patients about to undergo breast augmentation.

1.    All surgeons in the UK and France have been advised to quarantine any PIP implants- they should NOT be used under any circumstances.
2.    We understand that the manufacturers and suppliers are recalling all implants in the UK and France.
3.    It is not clear whether this advice is being adhered to in all countries. If you are travelling abroad for your surgery please ensure that you ask for full details of the type of implants that are to be used. PIP implants have always been know to be a cheaper, but poor quality option, for this reason they have often been the implant of choice for many “cut price” clinics. So, if you are being offered a cheap package check the details carefully.
4.    If a surgeon is not prepared to give you clear indications of the implant proposed DO NOT agree to surgery.

Further information

• If you wish to see a MyBreast surgeon for free advice please call us on 08707804000.
• Check the MHRA website.
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON076499

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Your comments

February 4th 2009 at 12:22:36

MB said ...

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???

May 13th 2009 at 17:35:25

Melissa Chaudhry said ...

I have had my implants for 14 months now and am very pleased with the size and shape however I still have some tenderness to my breasts and an achy feelling...I do go to the gym quite frequently and was wondering if using weights is affecting the healing process...I do also occassionly smoke approx 20 per week ( social) and wondered if this is also slowing down the healing...many tahnks

May 28th 2009 at 14:09:39

joanne said ...

i am 22 a size 34a i have had 2 children in 2 years and breastfed them both. i am 8.5 stone good skin 5.5 in height size 8 in clothes what size do you think i could go up to and they still look natural.

June 18th 2009 at 20:22:13

claire said ...

i am 30, no kids and am thinking about having breast augmentation due to different cup sizes which is noticable. Can you advise what I need to do.

June 30th 2009 at 16:17:34

sue said ...

I have had my silicone implants since 1990. I have never had a problem with them, but am worried about their durability, considering they are so old! How would I know if they were leaking? And would you recommend having them removed/replaced? Thank you, Sye

July 6th 2009 at 14:13:34

Julie Davies said ...

I thought of having implants since i was 20, now i am 34. Yes still thinking. I have had no children and do not lack self esteem either in a bikini or in any situation. I guess its just something a girl just wants to do. I have met a few Plastic Surgeons and not felt 100% happy with them. I am 34, 5'7, size 8 and currently 32C with a very small back. Would you recomend that i had it done and to what sensible size, that still looks natural. Many thanks

August 5th 2009 at 23:10:26

Lauren said ...

I am 24 years old. ive had twin boys 2 years ago. But i only ever went up one cup size, so I'm not saggy. I am getting Breast Implants a.s.a.p, I still can't decide what size to go up to without looking just like a big walking pair of boobs! I want to sit up high even without a bra. Pert, and firm. I am a 32/34A. My height is 5'5''. My waist is 26'' approx, my hips are 36/37'' approx. im a size 8 - 10. (Although at my slimest ive been a size 6 a few months ago.) What bust size would make me in good proportion?? I've been researching for so long now and still unsure of what size would suit me. Please help! Thank you. I was going to go up to a DD but i think this is too big now! I'm torn between a Full C or a Small D. but I am so unsure what my "ideal" size is?? Lauren

August 6th 2009 at 20:53:47

alix wright said ...

I am black british, healthy, 28 years of age. i have a scar that is keloid. will this happen if I have implants? id like to know how it would turn out.

August 10th 2009 at 21:29:00

Miss Linda Gordon said ...

I have booked my beast augmentation for 10th September. I am a 38A, have a large back size, but would like to be a nice full shape. considering a size 38D. I sometimes have to buy sizes 40A for the bra straps can be too tight at 38A or B. What size and shape can you advice me. I want to look full and natural. Can you help me, Linda

August 26th 2009 at 08:28:06

debra said ...

hi I had breast augmentation July 2008 I was really happy with the results at first but gradually they have dropped and seem to have 'shrunk', I wanted them natural looking but I feel that they don't look like they did when I first had them done. I have been back to the surgeon but he said that they are fine. I measured a D/DD but now I don't seem to fill the bra at the top there is alot of gaping. I have recently lost a stone in weight would that be a cause of my breasts to reduce even with implants in? I have always felt that the breast pocket has not been filled with the right sized implant if that makes sense. there is alot of movement in my breasts.

August 26th 2009 at 19:40:23

Lenka said ...

hello!I'm from Slovakia,but I'm working and living in Northern Ireland and I really want to have a bigger breast,because I think I have size 0,so I just want to ask you,when I have 155cm and 47 kg,how big implants can I have and for how much is that operation approximately?Thank you for your answer...

September 30th 2009 at 10:36:10

melissa said ...

I would like to have a breast enlargment and nose job but would like to know a rough guide to how much that would cost. And if i could get them down in one go?

October 7th 2009 at 15:31:20

May said ...

Hi there I had silicone breast implants about 12 years ago. I know they often only last about 10 years and wondered how I would know if they need replacing/removing. One breast has calcified over the past 5 years and is very firm, the other is soft however has started feeling tender recently. I am currently trying to conceive and wondered what I should do. Thank you

December 4th 2009 at 13:07:16

NIKKI said ...

MY BREAT IMPLANTS PIP CLOVERLEAF SILICONE - HAVE RUPTURED AND CAUSING ME TERRIBLE PAIN....ITS LEAKING INTO MY LYMPTH GLANDS AND MY WHOLE ARM IS NUMBE - MY SURGERON IS TRYING TO CHARGE ME AGAIN AND CLOVERLEAF WILL GIVE ME THE IMPLANTS BUT THATS IT....NHS WONT HELP..WHAT DO I DO?? PLEASE HELP

January 9th 2010 at 17:34:48

amy said ...

im 18, and am interested in breast augmentation i am a 34a and would like to know what size i could go up to? thanks

January 13th 2010 at 12:24:29

Angela Davies said ...

Hello, Could you please inform me if breast implants alone would lift breast. Kind regards, Angela Davies

January 31st 2010 at 23:06:54

sharon giliker said ...

this might not be connected but i've just had an mri scan on my neck and head, because the consultant thinks my adenoids have regrown. since then my neck had become swollen and that seems to have disappeared and my left implant had become very hard, swollen and hot. my implants were inserted 30th august 2007, i took myself off to a&e to which i were told there were no signs of infections, so i took myself to the surgeon who performed the surgery to be told he'd booked me into the local hospital for introvenous antibiotics and an ultrasound, upon having the ultrasound lots of bloody like fluid war drained but not all. breast had gone soft til about 5 hours later, i was given the option of leaving it to see how it settles or to go to theatre an have implant removed washed, inside my breast washed and implant re inserted but with a risk of infection and losing it. nhs wont pay for new ones and i'm still paying for the originals so i chose to wait and see, although i think this may have been a mistake now. is there any chance that the silicon implant may have ruptured and gone to my nodes as i'm now being told that when they rupture the cling to nodes, please can you answer asap as i've just had a biopsy as on the mri scan neck nodes were showing and they think its to do with my adenoids. i know this is a bit drawn out but i thought i'd give you most of the info i have. THANKS x

March 29th 2010 at 09:58:06

Karon said ...

MY BREAT IMPLANTS SILICONE - HAVE RUPTURED AND CAUSING ME TERRIBLE PAIN....ITS LEAKING INTO MY LYMPTH GLANDS AND MY WHOLE ARM IS BECOMING HOT AND NUMBE - MY SURGERON IS TRYING TO CHARGE ME AGAIN AND WILL GIVE ME THE IMPLANTS BUT THATS IT....NHS WONT HELP..WHAT DO I DO?? PLEASE HELP

April 8th 2010 at 21:28:08

yuna said ...

Hi: I have had my silicone implants since 2002. I never had any checks afterwards as it's done overseas, but think it's ok. Now as it's being 8 years, i am worried about their durability, How would I know if they were leaking? is there any checks i could do to check my health is alright? And would you recommend having them removed/replaced? Also, i'm in manchester, will i be able to see the surgeon in Manchester? Thank you very much. Yuna

April 16th 2010 at 06:12:08

Maria - Sydney Australia said ...

I have just been informed that the silicone implants i had 3.5 yrs ago are the PIP ones. I have annual check ups & don't have a problem so unsure what I should do ?

April 26th 2010 at 09:02:00

Miss Rose said ...

Hi Maria, Sydney Australia, definitely keep having check ups! I would also speak with your surgeon given the news on PIP implants.

April 28th 2010 at 12:41:49

cathy said ...

Hi I'm 20 and really interested in breast enlargement but am just slight of concern about the outcome of them. I want a really natural looking pair but from reading others stories I am worried about them dropping or the asymmetry being wrong. Also wondering why saline implants are not used? I have saved enough money to have the procedure and would really love it but I'm just having these draw backs at the moment. Also wondering how much approx this would cost? Cathy

July 2nd 2010 at 17:04:00

mel ellis said ...

im 28 and was diagnosed with relapsing remitting ms 6 years ago,ive thought of having breast enlargement for some time now but wonder how this will affect my ms? would a surgeon even operate on me,and after the things ive read about silicone,would i be better having saline filled implants or are these no longer used?

July 7th 2010 at 01:23:31

sandra said ...

i had breast done over a year ago,but on my left breast is still numb. am i ever going to get all the feeling on my breast?

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