BAPRAS issues advice to women with PIP breast implants

21st December 2011

 

Q: I have had breast implants but how do I know if I have PIP implants?

A: 40,000 PIP breast implants have been used for breast reconstruction and/or breast enlargements in the UK, for operations between 2001-2010.  This is a small proportion of the breast implants that are used overall.

To confirm whether you have PIP implants or not, you should contact the clinic where the surgery took place and they will have a log of the implants used.

Q: I know I have PIP breast implants, should I be worried?

A: The PIP implants have been shown to have a slightly higher incidence of rupturing than other implants used as there is some evidence of a weakness in their outer shell. This is one of the reasons why they were withdrawn from the market.

It should be emphasised that the rupture of a breast implant is not a dangerous event.  A ruptured implant may change shape, harden, become painful or present with a new lump in the breast.  If any of these features occur it would be wise to consult your surgeon.

Tests that have taken place on the silicone gel filler material used in the PIP breast implants do not currently show any genotoxic effects for the PIP silicone gel filler material.  There is no reason to suspect they can cause breast cancer, nor is there any evidence of health risks, whether they are ruptured or not.  

Advice to patients from the Medicines and Healthcare products Regulatory Agency (MHRA), the UK government agency which is responsible for ensuring that medicines and medical devices work and are safe, continues to be that there is no evidence of any abnormal health effects associated with the implant filler material. For further information visit: http://www.mhra.gov.uk/

The MHRA is working closely with the French Authorities (the AFSSAPShttp://www.afssaps.fr/) and reviewing all information available.

If you are worried then contact your clinic or implanting surgeon to discuss the situation.

Q: I have had breast implants and know they are not PIP implants but I am still worried; what should I be looking out for?

A: Incidents with breast implants are extremely rare but if any changes in the look or feel of the breast are experienced, women should contact their clinic, implanting surgeon or another surgeon experienced in the field.  

Q: What should I do next?

A: You do not need to do anything as clinics will be in contact with any patients who have PIP implants if action is required.  

However, if you have any queries or concerns your should talk to your clinic or implanting surgeon.

Q: If there is no cause for alarm why are the French removing all these implants?

A: At present there is a speculative piece in a French newspaper suggesting these implants might be better removed.  Each government makes its decision based on local considerations, but at present no government has recommended routine removal of PIP implants

Q: If there is no cause for alarm why are there so many stories about these implants at the moment?

A: Stories about breast implants are always topical and of interest but sometimes the reporting can create alarm without reason.  

In the UK the competent authority is the MHRA who have been monitoring many different aspects for PIP breast implant safety since the French regulators identified a problem with manufacturing standards nearly a year ago. The MHRA has commissioned detailed and searching tests in all aspects of safety for these implants. Like those conducted in France and other countries they have so far shown no cause for alarm or any indication that these implants pose a risk to health.

Q: Should I have my implants removed anyway?

A: All breast implants have a limited life. The normal recommendation is that for women whose breasts remain free of any new symptoms (as most breasts with implants do) then at ten years after implantation it is wise to have them checked by a surgeon. In most cases no action other than monitoring over the years is needed.

It is thought that the manufacturing standards of PIP implants may make them prone to need removal or exchange earlier than most. Women concerned should consult their implanting surgeon or a surgeon experienced in breast augmentation.

 

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