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Section highlightThe Housing (Wales) Bill
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Poly Implant Prothese (PIP) silicone breast implants
Advice to Women
I have a PIP silicone breast implant; what should I do?
We recommend that all patients who have questions about their PIP breast implants should seek advice from their implanting surgeon or organisation which originally provided your implant surgery.
If this is not possible you should make an appointment to discuss the situation with your General Practitioner.
I have a silicone breast implant but not made by PIP; what should I do?
The current problem only relates to silicone breast implants made by PIP. There is therefore no need to take any further action. However, if you have any concerns about your implant, you should seek advice from your implanting surgeon.
Contact the organisation which originally provided your implant surgery or hospital you were operated in, and ask to speak to the surgeon’s secretary.
I have a silicone breast implant but don’t know if it was made by PIP; what should I do?
You should contact the organisation which originally provided your implant surgery or your implanting surgeon for confirmation of the type of implant used and, if made by PIP, seek advice from the surgeon. If you had your surgery in Wales then you will not have received a PIP implant.
I have tried to contact the clinic which performed my implant by they are no longer in business, or are refusing to help unless I pay for a further procedure; what can I do?
In the first instance, you should contact your GP to discuss options for referral to a specialist for a clinical review. If it is agreed that the most appropriate outcome would be removal of the implant, NHS Wales will also replace the implant.
You will however need to demonstrate the action you have taken to seek redress from the private provider.
Why not arrange for all PIP silicone breast implants to be checked by MRI or ultrasound?
MRI or ultrasound scanning is used to see if there is any evidence that the implant has ruptured. Scanning would not predict if the implant was likely to rupture in the future.
What symptoms should I look out for to indicate that a silicone breast implant may have ruptured?
A rupture is a split that occurs in the implant’s casing. A rupture can be caused if:
- the implant’s shell (that holds the silicone or saline) gets weaker over time;
- the implant is damaged during the operation;
- there is a flaw in the implant; or
- the breast is injured.
When implants were first developed, they had very thin walls and rupturing was a common problem.
However, modern implants that have been used in the UK since the 1990s rupture much less frequently.
If your implant ruptures, it is recommended that you should have it removed and, if you wish and it is clinically appropriate, a new one may be inserted.
If you have silicone implants, silicone that leaks out of a ruptured implant may cause problems, such as siliconomas or a gel bleed (see below).
If you have a silicone breast implant that ruptures, the silicone may spread outside of the scar capsule and into your breast. This can lead to small lumps developing that are known as siliconomas.
Siliconomas can be tender to touch and if they are causing significant pain they may need to be removed. In rare cases, the silicone can spread to the muscles under your breast, your armpit or around the nerves to your arm.
A gel bleed is where tiny particles of silicone are released from the surface of a silicone breast implant. This can occur when the breast implant ruptures, or sometimes it can happen when there is no rupture.
If the silicone particles get into the lymphatic system (the network of vessels that help the body to fight infection), they can be transported to nearby lymph nodes (glands), such as those in the armpit. This may cause the lymph nodes to become slightly swollen. This is usually a minor problem, although in some cases the enlarged lymph nodes may become uncomfortable.
What should I do if I experience these symptoms?
You should contact and seek advice from your implanting surgeon. If you are unable to contact your implanting surgeon you can contact your GP for further advice.
Why not remove all PIP implants in the UK?
The Expert Group reviewed the available data and concluded that there is no clear evidence at present that patients with a PIP implant are at greater risk of harm than those with other implants.
There are risks associated with any surgical intervention, and it is not believed that the associated risks of surgery from breast implant removal can be justified without further evidence.
What are the risks associated with a PIP silicone breast implant remaining in me?
The Medicines and Healthcare Products Regulatory Agency (MHRA) commissioned toxicity testing on the unapproved silicone gel used to fill PIP breast implants, including genotoxicity (to see if it caused damage to genetic information) and chemical toxicity.
The results of these tests have been discussed with relevant experts and it was concluded that there is no safety issue related to this filler material. Similar testing carried out by the French medicines and medical devices regulator confirmed these conclusions.
Why did this happen?
In March 2010 the MHRA were informed that due to a slightly increased rupture rate the French regulatory authority investigated the manufacture of PIP implants. The inspection revealed a possible problem with the breast capsule design and the filler material and therefore the regulator stopped production.
The MHRA for the UK issued an immediate Medical Device alert to stop implantation with PIP implants here.
Where can I find further information?
The Welsh Government has issued a patient pathway to make clear for patients, clinical professionals and NHS managers the proposed arrangements to assess and care for women with PIP breast implants. A copy of the pathway is available on this website.