Many newspapers today reported details of a possible link between a French brand of breast implants and a rare form of cancer. It is thought that up to 50,000 British women have had the implants concerned, which are subject to a major investigation in France.
The brand of implants, Poly Implant Prothese (PIP), was withdrawn from the market last year and investigated by health regulators after it was found to contain non-medical types of silicone. After examining a range of data, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) found that there was “insufficient evidence” of any association between PIP implants and cancer. However, the implants have remained under scrutiny, particularly since a French woman with the implants died of a rare form of cancer known as ALCL.
Media coverage of this story has been confusing and contradictory, with some sources suggesting the implants pose a major risk and others echoing health regulators’ advice, which is that there is no evidence that the implants cause cancer. To date, many thousands of women have had PIP implants and there have only been a very small number of ALCL cases worldwide, with no clear link between the two. However, the situation is being monitored by both UK and French authorities.
At present, it appears there is no need to have these types of implants removed, but women with breast implants are advised to speak to their implant surgeon if they have concerns or if they think their implants may have ruptured.
Why are breast implants in the news?
Earlier this month, French medical authorities set up a review of PIP implants following the death of a woman from anaplastic large cell lymphoma (ALCL), a rare type of cancer that affects the cells of the immune system. It reportedly developed in the breast’s capsular scar tissue, a layer of tissue that often forms around an implant. The patient in question had PIP breast implants.
Another eight cancer cases are reported to have been found in women with PIP implants, although there isn't any evidence of a link between these cases and the implants.
Could the implants have caused the woman’s cancer?
The UK’s medicines and healthcare products regulatory agency (MHRA) has said there is “insufficient evidence” of any association between these implants and cancer. Previous tests by the French and UK regulatory authorities found the gel filler used in the implants did not show any chemical toxicity or “genotoxicity” (potential for causing cancer) and that there was no evidence of any abnormal health effects. However, the French authorities found that the PIP gel had an “irritant behaviour” that was not found with other silicone gels.
The British Association of Aesthetic Plastic Surgeons has also pointed out that, although there is a “possible association” between the implants and ALCL, a direct link between the two has not been established. The association also stresses that ALCL is extremely rare and that there have been only a small number of reported cases worldwide among the many thousands of women with PIP implants.
What types of implants are involved?
The implants involved are called Poly Implant Prosthese (PIP) and were made by a French company of the same name. They were pre-filled with a silicone-based gel (the majority of women having breast implants now have silicone implants). However the marketing, distribution and use of the PIP implants was suspended in March 2010 after an inspection of the PIP manufacturing plant in France. This revealed that the breast implants, manufactured since 2001, had been filled with a silicone gel with a different composition from the approved type, thought to be intended for industrial not medical use. As a result, in March 2010 the MHRA advised doctors not to use these implants any more. Later that year it issued advice to surgeons on how to manage women who already had PIP implants.
Have the PIP implants been associated with any other problems?
The French regulatory authority previously reported that the implants varied in quality and had a “highly variable” rupture rate of up to 10%. The gel used leaked through the shell in up to 11% of cases. They pointed out that in cases of rupture or leakage, storage of the gel in nearby lymph nodes can cause pain and inflammation.
At that time, the French authorities said that if symptoms were very disabling then removal of the implants should be considered. The French authorities recommended a clinical examination and an ultrasound scan for women with PIP implants every six months, and that the implants should be removed after any rupture or leakage.
In the UK, the MHRA has said there was no indication that women would routinely need their implants removed or have to have ultrasound investigations.
What do the authorities say?
After reviewing the available evidence and cancer registries with the relevant UK professional bodies, the MHRA said that it has found “insufficient evidence to indicate any association with cancer”. The MHRA continues to monitor the use of all types of breast implants, including PIP, to look for any associations with cancer and any other health effects. It is continuing to liaise with the French authorities and will consider any new evidence that comes to light as soon as possible.
Should I have my implants removed?
The current advice is that all women with implants who are concerned about their breasts or think that their implants may have ruptured should seek advice from their implanting surgeon.
The British Association of Aesthetic Plastic Surgeons advises women with the PIP implants to have a scan every six months and that if there is any rupture or weakening, or if there are sudden unexplained changes or swelling in their breasts, to have the implants removed.
Analysis by Bazian
Edited by NHS Website
Links to the headlines
Daily Mail, 21 December 2011
BBC News, 21 December 2011
December 20 2011
December 20 2011
December 3 2011