Press statement: PIP breast implants – UK medical devices regulator says no evidence to support routine removalPrinter friendly version (new window)
Press statement
Date: 23/12/2011
Time: 11:00
Contact: Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189
Following the announcement in France today, the Medicines and Healthcare products Regulatory Agency (MHRA) is not recommending routine removal of PIP silicone gel breast implants in the UK.
We recognise the concern that some women who have these implants may be feeling but we currently have no evidence of any increase in incidents of cancer associated with these implants and no evidence of any disproportionate rupture rates other than in France.
We therefore do not believe that the associated risks of surgery from breast implant removal can be justified without further evidence.
We will continue liaising with the French medicines and medical devices regulator and we are awaiting the evidence to support the decision made in France. This will be evaluated as a matter of priority by our clinical and toxicological experts and we will issue further advice if necessary.
In the absence of strong clear evidence to the contrary, we see no reason to alter our current advice that there is no need to routinely remove these PIP breast implants.
In the meantime we would recommend that all patients who have questions about their PIP breast implants should seek advice from their implanting surgeon.
We had discussions on 21 December 2011 with other health or regulatory experts from France, the Netherlands, Portugal, Italy, Ireland, Hungary, Austria, Denmark and Malta. They all agreed that there was no evidence of any increase in incidents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates other than in France. Information obtained from the Australian Regulatory Authority (TGA) is consistent with the figures from all the above European countries other than France in terms of rupture. They have no reported cases of lymphoma.
We have continually monitored the safety of these breast implants. In March 2010 we advised clinicians not to implant these devices and at the same time advised patients who were concerned about their PIP implants to consult their implanting surgeon. MHRA commissioned toxicity testing on the unapproved silicone gel used to fill PIP breast implants, including genotoxicity and chemical toxicity. The results of these tests have been discussed with relevant experts and we have 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.
Notes to Editor
1) Please see the MHRA’s medical device alert issued on 31 March 2010:
Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP) - All models and lot numbers (MDA/2010/025)
2) Please see the MHRA’s previous press releases about the testing of the unapproved silicone gel used to fill PIP breast implants:
31 March 2010 - Press release: Advice issued to breast implant surgeons
1 September 2010 - Press release: PIP (Poly Implant Prosthese) breast implants – UK test results
28 September 2010 - Press release: French authority test results for silicone gel filled breast implants manufactured by PIP (Poly Implant Prosthese)
21 April 2011 - Press release: French regulator confirms non-toxicity of PIP breast implants
3) The MHRA is aware of the US Food and Drug Administration’s (FDA) January 2011 Medical Device Safety Communication entitled 'FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma in Women with Breast Implants'.
4) The MHRA informed UK healthcare professionals about the FDA’s communication via a medical device alert issued in February 2011.
Medical Device Alert: All types, makes and models of breast implants (MDA/2011/017)
The MHRA also continued to review available evidence for association of cancers of women with breast implants in consultation with the relevant UK professional bodies for breast surgery and surgical oncology and has concluded that there is no evidence to indicate an association with cancer. Additionally the MHRA worked with the Cancer Registry and could find no evidence for an association. The MHRA has not received any reports of women with breast implants of any type in the UK with a diagnosis of anaplastic large cell lymphoma (ALCL).
Also, the MHRA consulted with experts to discuss whether there was any danger to babies having been breast fed by mothers with these implants. It was concluded that there were no safety issues.
5) Based on reports to the MHRA from our Adverse Incident Centre (AIC) approximately 1% of women in the UK with PIP breast implants have suffered implant failure, including rupture. This contrasts with information from the French medical device regulatory authority, AFSSAPS, which suggests a failure rate, including rupture, of around 5% in France.
6) The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk
Download documents:
Press statement: PIP breast implants – UK medical devices regulator says no evidence to support routine removal (72Kb)
Press statement
Date: 23/12/2011
Time: 11:00
Contact: Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189
Following the announcement in France today, the Medicines and Healthcare products Regulatory Agency (MHRA) is not recommending routine removal of PIP silicone gel breast implants in the UK.
We recognise the concern that some women who have these implants may be feeling but we currently have no evidence of any increase in incidents of cancer associated with these implants and no evidence of any disproportionate rupture rates other than in France.
We therefore do not believe that the associated risks of surgery from breast implant removal can be justified without further evidence.
We will continue liaising with the French medicines and medical devices regulator and we are awaiting the evidence to support the decision made in France. This will be evaluated as a matter of priority by our clinical and toxicological experts and we will issue further advice if necessary.
In the absence of strong clear evidence to the contrary, we see no reason to alter our current advice that there is no need to routinely remove these PIP breast implants.
In the meantime we would recommend that all patients who have questions about their PIP breast implants should seek advice from their implanting surgeon.
We had discussions on 21 December 2011 with other health or regulatory experts from France, the Netherlands, Portugal, Italy, Ireland, Hungary, Austria, Denmark and Malta. They all agreed that there was no evidence of any increase in incidents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates other than in France. Information obtained from the Australian Regulatory Authority (TGA) is consistent with the figures from all the above European countries other than France in terms of rupture. They have no reported cases of lymphoma.
We have continually monitored the safety of these breast implants. In March 2010 we advised clinicians not to implant these devices and at the same time advised patients who were concerned about their PIP implants to consult their implanting surgeon. MHRA commissioned toxicity testing on the unapproved silicone gel used to fill PIP breast implants, including genotoxicity and chemical toxicity. The results of these tests have been discussed with relevant experts and we have 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.
Notes to Editor
1) Please see the MHRA’s medical device alert issued on 31 March 2010:
Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP) - All models and lot numbers (MDA/2010/025)
2) Please see the MHRA’s previous press releases about the testing of the unapproved silicone gel used to fill PIP breast implants:
31 March 2010 - Press release: Advice issued to breast implant surgeons
1 September 2010 - Press release: PIP (Poly Implant Prosthese) breast implants – UK test results
28 September 2010 - Press release: French authority test results for silicone gel filled breast implants manufactured by PIP (Poly Implant Prosthese)
21 April 2011 - Press release: French regulator confirms non-toxicity of PIP breast implants
3) The MHRA is aware of the US Food and Drug Administration’s (FDA) January 2011 Medical Device Safety Communication entitled 'FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma in Women with Breast Implants'.
4) The MHRA informed UK healthcare professionals about the FDA’s communication via a medical device alert issued in February 2011.
Medical Device Alert: All types, makes and models of breast implants (MDA/2011/017)
The MHRA also continued to review available evidence for association of cancers of women with breast implants in consultation with the relevant UK professional bodies for breast surgery and surgical oncology and has concluded that there is no evidence to indicate an association with cancer. Additionally the MHRA worked with the Cancer Registry and could find no evidence for an association. The MHRA has not received any reports of women with breast implants of any type in the UK with a diagnosis of anaplastic large cell lymphoma (ALCL).
Also, the MHRA consulted with experts to discuss whether there was any danger to babies having been breast fed by mothers with these implants. It was concluded that there were no safety issues.
5) Based on reports to the MHRA from our Adverse Incident Centre (AIC) approximately 1% of women in the UK with PIP breast implants have suffered implant failure, including rupture. This contrasts with information from the French medical device regulatory authority, AFSSAPS, which suggests a failure rate, including rupture, of around 5% in France.
6) The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk
Download documents:
Press statement: PIP breast implants – UK medical devices regulator says no evidence to support routine removal (72Kb)
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