In news that sounds more like something from an automotive, or white goods recall, French authorities have announced that a certain type of silicone breast implant can rupture and might cause cancer. The French authorities are in the process of deciding whether to issue a “recall” and recommend up to 30,000 French women have their implants changed or removed.
Meanwhile in the UK, The Medicines and Healthcare products Regulatory Agency (MHRA) has advised that there is not enough evidence to warrant removal. Dr Susanne Ludgate, the medical director at the MHRA, explained that they have looked at the issue extensively, including the toxicity of the filler. She stated that they have looked at any association with cancer and can find no link, and they have also looked at safety issues of women breast feeding with the implants.
“We would really advise women in this country (The UK) not to panic … In terms of cancer we have to keep on looking at the evidence and ensuring that we keep on looking at it, rather than taking a snapshot at one point in time.”
The French health authorities will release their judgment on the issue on Friday 23rd December 2011, but their final take on the matter is not clear.
The product causing the uproar, is known as Poly Implant Prosthese (PIP) Breast Implants. They have been associated with an anaplastic large cell lymphoma (ALCL). It’s a rare form of cancer that affects the cells of the immune system.
The implants were manufactured by a French company that is now closed down. As many as 300,000 implants have been used to enhance or replace lost breast tissue and were sold worldwide before PIP went into administration in 2010, and use of their product was halted. The French have cited 8 cases of cancer to date, in contrast to the British advice, that the implants do not appear associated with cancer.
The issue began in 2010, when the French authorities discovered that PIP had changed the type of filler it was using, for an unauthorized silicone gel and not the originally approved material. In the spirit of a true recall, they also confirmed that if a genuine link with cancer is confirmed, that the French social security will pay for all women to have the implants removed. They didn’t specify whether that would cover women worldwide, or if replacements implants would also be provided at no charge.
In the US, The Food and Drug Administration in Jan. 2011, issued a Medical Device Safety Communication entitled ‘FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma in Women with Breast Implants. The UK followed suit in Feb. 2011.
The MHRA states that they have continued to monitor the issue and investigate the link with cancer of the implants but state :
Our current advice to women with PIP breast implants continues to be that should they have any questions about their breasts or implants, that they should seek clinical advice from their implanting surgeon … There is currently no evidence to support routine removal of PIP breast implants.”
But with the NHS (National Health Service, UK) and the British Government under increasing financial strain, some may wonder whether the MHRA downplaying the issue, might be associated with avoiding the costs of a UK “recall”. We will have to wait for Friday and see what the French authorities decide.
Written by Rupert Shepherd