On 29 March 2010, the French medical device regulatory authority (AFSSAPS) informed the MHRA that it had suspended the marketing, distribution, export and the use of silicone gel filled breast implants manufactured by Poly Implant Prosthèse (PIP), a French breast implant manufacturer. Following an inspection of the PIP manufacturing plant, AFSSAPS had established that breast implants manufactured since 2001 had been filled with a silicone gel with a composition different from that approved.
On 31 March 2010, MHRA issued a Medical Device Alert (MDA/2010/025) advising UK clinicians not to implant these devices. The MHRA also produced a set of questions and answers for members of the public.
In April 2010, AFSSAPS initiated testing of affected implants to look at the genotoxicity (potential for cancer), cellular toxicity and irritation to biological tissues. In addition, mechanical testing of the implant shell was carried out. At the end of June 2010, AFSSAPS told the MHRA of delays to their product testing. Because the MHRA was aware of the concerns of implanted women, it decided to commission some limited testing to obtain an early indication of genotoxicity. It was recognised that these were not as extensive as the tests being carried out in France, but it was agreed with the relevant experts on the Committee on the Safety of Devices that these would give important information on whether there potential health risks associated with the filler material.
In early September 2010 the MHRA announced encouraging results of the UK testing (26Kb), with no evidence of safety issues associated with the filler material.
On 28 September 2010 AFSSAPS published a statement with the findings of their results. The French results confirmed the UK findings reported at the beginning of September 2010 that there is no evidence of genotoxicity (potential for cancer) or cellular toxicity of the filler material in the implants. Mechanical testing of the implant shells carried out by AFSSAPS also suggested that there may be an increased risk of rupture. AFSSAPS provided a summary of the tests that they had conducted in their topical report dated June 2011.
On 04 October 2010 MHRA issued a further Medical Device Alert (MDA/2010/078) advising UK clinicians on the clinical management of women implanted with PIP silicone gel filled breast implants.
On 14 April 2011 AFSSAPS published a statement with the results of additional tests (65Kb) on the silicone gel filler material used in PIP breast implants. AFSSAPS concluded that these results did not show any genotoxic effects for the PIP silicone gel filler material.
The Therapeutic Goods Administration (TGA) of the Australian government also carried out tests on PIP breast implants in 2010. They concluded that these implants conformed to the relevant international standards for this type of product including those for gel cytotoxicity and shell strength. On 12 January 2012 the TGA published a summary report of the findings from the tests they had conducted in April 2010. A report of these findings is available on the TGA website (external link).
On 23 December 2011 the French Government announced that it was recommending that all women who had been implanted with PIP breast implants should have them removed as a preventative measure because of “the well documented risks associated with these implants” ie ruptures and the gel’s capacity to cause irritation that may lead to inflammatory reactions.
On 31 December 2011 the Secretary of State for Health asked the NHS Medical Director to launch a review into the PIP breast implant situation by leading an Expert Group to provide advice about whether further steps needed to be taken and whether there were wider lessons to be learnt for regulation of safety and quality in cosmetic surgery. The Expert Group published their interim report (external link) on 6 January 2012. The report concluded that:
- PIP implants were not associated with a higher risk of breast cancer or other forms of cancer than other breast implants – indeed, the incidence of breast cancer for women with PIP implants is lower than that in the general female population.
- standard toxicological tests carried out in the UK, France and Australia showed no evidence of cytotoxicity (damage to cells) or genotoxicity (genetic mutations).
- the available evidence is subject to considerable uncertainty and therefore they recommended the collection of additional information which will enable the group reach a more informed view.
The Expert Group commissioned further chemical and toxicological testing to establish whether, and to what extent, the silicone gel used in PIP breast implants may be associated with increased health hazards compared with conventional ‘medical grade’ silicone. The group also requested the MHRA to contact all the major providers of breast implants, both in the NHS and in the private sector, and to ask them to complete a questionnaire seeking information for both PIP and other brands on:
- the total number of women who received implants each year over the period 2001-2011
- the reasons for explantation, and the clinical findings at explantation, of all explantations carried out over the same period.
The final report of the Expert Group (external link) was published on 18 June 2012. Their main conclusions were that:The final report of the Expert Group was published on 18 June 2012. Their main conclusions were that:
- rigorous world-wide chemical and toxicological analyses of a wide variety of PIP implants have not shown any evidence of significant risk to human health
- there is no reason to believe that further testing will change this conclusion, given the results of the chemical analysis and the number of batches that have now been tested world-wide, which have all reached a similar conclusion
- PIP implants are significantly more likely to rupture or leak silicone than other implants, by a factor of around 2-6, and this difference is detectable within five years of implantation
- in a proportion of cases, failure of the PIP implant results in local reactions but these are readily detected by outward clinical signs – 'silent' ruptures (ruptures which come to light only on explantation) are not generally associated with these local reaction
The Expert Group further concluded that PIP implants are clearly substandard although there is no evidence of a significant increased risk of clinical problems in the absence of rupture. In the light of these conclusions they reiterated and amplified previous advice that:
- all providers of breast implant surgery should contact any women who have or may have PIP implants– if they have not already done so – and offer them a specialist consultation and any appropriate investigation to determine if the implants are still intact
- if the original provider is unable or unwilling to do this, a woman should seek referral through her GP to an appropriate specialist
- if there is any sign of rupture, she should be offered an explantation
- if the implants still appear to be intact she should be offered the opportunity to discuss with her specialist the best way forward, taking into account the factors listed in paragraph 33 of this report
- if in the light of this advice a woman decides with her specialist that, in her individual circumstances, she wishes to have her implants removed her healthcare provider should support her in carrying out this surgery. Where her original provider is unable or unwilling to help, the NHS will remove but not normally replace the implant
- if a woman decides not to seek early explantation, she should be offered annual follow up in line with the advice issued by the specialty surgical associations in January 2012 . Women who make this choice should be encouraged to consult their doctor if they notice any signs of tenderness or pain, or swollen lymph glands in or around their breasts or armpits, which may indicate a rupture. At the first signs of rupture, they should be offered removal of the implants.
For further information on the results of the Expert Group testing and clinical findings analysis, see:
MHRA toxicology testing and collection of clinical findings upon removal of the implant