08 October 2010
Following an alert last year, the French medical device regulatory authority (AFSSAPS) and UK Medicines and Healthcare products Regulatory Agency (MHRA) have released their findings into tests of PIP implants.
There is NO evidence that the implants are harmful. Please see here for the AFSSAPS press release.
Current advice is that removal is not required but an ultrasound should be performed every six months.
What is this all about?
Earlier this year the UK MHRA issued an alert about PIP implants, a brand of silicone gel-filled breast implants made in France and used by many providers across the UK since 2001. All unused implants were recalled and the marketing, distribution, export and use of them was suspended as a precautionary measure.
The alert was issued after an inspection of the PIP manufacturing plant showed that, since 2001, breast implants manufactured by the company have been filled with a silicone gel that was not approved by the AFSSAPS. The AFSSAPS and MHRA have established that there is no evidence that PIP implants are harmful, however there may be an increased rupture rate compared with other breast implants.
What should I do if I’m not sure if my implants are PIP?
Your surgeon should have provided you with documentation of the type and make of implant used at the time of your surgery. If you have lost this information please contact your surgeon who should be able to provide details. If you cannot remember who your surgeon is please contact the hospital where you had your operation.
What should I do if I have had PIP implants?
The MHRA and AFSSAPS have found that the materials used in PIP implants is not harmful. The current advice is that removal is not required at this stage.
If there are any signs that concern you, you should arrange to consult your surgeon. If you cannot reach your surgeon please contact the hospital where you had your operation.
I have had implants but they’re not PIP – are there problems with any other brands?
No, the MHRA alert is only related to PIP implants.
I’m about to have a breast augmentation – how do I know I won’t have PIP implants?
All PIP implants have been recalled and they are no longer being used in any UK hospitals. Your surgeon will decide which brand of implant is the most suitable for you and they should be happy to discuss the different options available.
How can I get more information?