There is not enough evidence to recommend the routine removal of PIP breast implants, a government expert committee has concluded.
However, the committee said the NHS would remove and replace the implants without charge if patients it had operated on remained concerned. The government said it expected the private sector to follow suit and not to charge for corrective procedures.
The French implants caused global concern after it was revealed they contained industrial silicone rather than medical-grade fillers and that they may be more prone to rupture and leakage. Some 40,000 women in the UK are believed to have had the implants, with 95% of operations done for cosmetic reasons through private clinics.
The expert group recommended that any worried woman should speak to her surgeon or GP.
NHS medical director Professor Sir Bruce Keogh, who led the expert review group, said: “On the basis of the information we have, we do not think it is necessary to recommend the routine removal of these implants.
“But we understand that some women will be very concerned so we support the government’s position that the NHS will support removal of PIP implants if the patient has concerns and, with her doctor, she decides that it is right to do so.”
Andrew Lansley, the health secretary, said he was putting patients’ interests first. “We believe that private healthcare providers have a moral duty to offer the same service to their patients that we will offer to NHS patients - free information, consultations, scans, and removal if necessary.”
What type 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 regulators found that the manufacturers were using silicone intended for industrial use, and not medical-grade silicone fillers. It is reported that the company used a cheap type of silicone gel intended for making mattresses. They had been manufactured since 2001.
As a result, in March 2010 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) advised doctors to stop using the implants. The agency then examined evidence on any possible toxic effects of the implants involved, and found that there was no evidence the unapproved filling could cause health problems. Later that year it issued advice to surgeons on how to manage women who already had PIP implants.
In light of the ongoing global concern, the government launched an expert review of the evidence on PIP implants and today released its guidance for patients, the NHS and private cosmetic surgery companies.
What happens if I got a PIP implant through the NHS?
There is no need to remove all PIP implants, but women who received a PIP implant from the NHS will be contacted to let them know they have one. They will be given information and advice. In the meantime, NHS patients can also request information about the make of their implant, which will be provided free of charge.
If you wish to, you will also be able to seek a consultation with your GP or with the surgical team who carried out the original operation. They will offer clinical advice on the best way forward. This could include an examination using scans, such as MRI, to look for any signs that the implant may have ruptured.
The NHS will support removal of PIP implants if a woman and her doctor decide that it is right to do through an assessment of clinical need, risk or the impact of unresolved concerns.
The NHS will replace the implants if the original operation was done by the NHS.
What if I obtained implants privately?
The government is working with the private sector to ensure an equivalent care system is provided to women who obtained implants privately. The government has stated that it does not think it is fair to the taxpayer for the NHS to foot the bill.
If a clinic that implanted PIP implants no longer exists or refuses to care for their patient, then, so long as that patient is entitled to NHS services, the NHS will cover the cost of the removal of PIP implants in line with the guidance.
Any NHS service in these circumstances would not include the replacement of private cosmetic implants. The government says that it will pursue private clinics with all means at its disposal to avoid the need for the taxpayer to pick up the bill.
Are the implants safe?
During December 2011 UK media had originally focused on a possible link between PIP implants and a rare type of cancer called anaplastic large cell lymphoma (ALCL). This arose after a French woman with PIP implants developed the cancer and died. However, after reviewing the evidence, the expert group conducting the review agreed that there was no link with cancer. Other sources have highlighted the large number of women around the world with PIP implants and the tiny number of ALCL cases.
More recently, attention has focused on the rupture rate of the implants, and whether the unapproved gel filling of PIP implants could have a toxic affect. The review has specifically looked at these issues, and found:
- The data provided by industry has been “patchy”, and that good data is necessary to ensure that problems are discovered when they arise
- From the data available, the review panel was not able to tell whether the rupture rate for PIPs is higher than for other types of implant
- From the implants that have been tested there appears to be no risk of dangerous toxic effects in the event of a rupture
- The review group said it could not be certain that the manufacturer did not change the content of the implants, so could not completely rule out the possibility that some might contain toxic substances.
The group also highlighted the need to ensure the safety of people having cosmetic surgery. In response Sir Bruce Keogh’s Expert Group will examine the wider issues around quality of data monitoring and the way the wider sector is regulated. The Care Quality Commission is also reviewing the evidence of providers’ compliance with registration requirements and is considering a fuller programme of inspections based on that.
What is a rupture and what are the signs?
A rupture is a split that occurs in the implant’s casing. A rupture can be caused if:
- the implant’s shell (that holds the silicone or saline) gets weaker over time
- the implant is damaged during the operation
- there is a flaw in the implant
- the breast is injured
When implants were first developed, they had very thin walls and rupturing was a common problem. However, modern implants that have been used in the UK since the 1990s rupture much less frequently. If an implant ruptures, it is recommended that it be removed and replaced with a new one. If it is a saline implant, any leakage from the implant is not expected to cause problems as saline is a sterile, saltwater solution that the body is able to safely absorb. However, with silicone implants, silicone that leaks out of a ruptured implant may cause problems, such as siliconomas or a gel bleed.
A siliconoma is a small lump formed of silicone that has spread outside of the scar capsule and into the breast. Siliconomas can be tender to touch and if they are causing significant pain they may need to be removed. In rare cases, the silicone can spread to the muscles under the breast, armpit or around the nerves to the arm.
Gel bleeds are where tiny particles of silicone are released from the surface of a silicone breast implant. This can occur when the breast implant ruptures, or sometimes it can happen when there is no rupture. If silicone particles get into the lymphatic system (the network of vessels that help the body to fight infection) they can be transported to nearby lymph nodes (glands), such as those in the armpit. This may cause the lymph nodes to become slightly swollen. This is usually a minor problem, although in some cases the enlarged lymph nodes may become uncomfortable.
MRI scanning is considered to be the most effective method of detecting “silent rupture” of silicone gel-filled breast implants. In the US the FDA recommends that women with silicone gel-filled breast implants receive MRI screening for silent rupture three years after receiving their implant, and then every two years. In the UK women can get specific advice from their implanting surgeon.
Who has produced the faulty breast implants?
The implants that are being examined were made by the now defunct French company Poly Implants Prothèses (PIP). Its former owner, Jean Claude-Mas, is facing investigation by French police, according to the Daily Mail. The Guardian has said French papers claim Mr Mas was aware that the wrong type of silicone was being used for 13 years without problems and that it was seven times cheaper than medical-grade silicon.
Several newspapers have reported that in police interviews from 2010 - quoted in French newspapers - Mr Mas had nothing to say to people affected. He is also reported as confirming that he had had confidence in his products and that he had no knowledge that they would rupture.
- MHRA: Poly Implant Prosthese (PIP) breast implants update. December 20 2011
- British Association of Plastic, Reconstructive and Aesthetic Surgeons: Response to French health warning on PIP Breast implants. December 20 2011
- British Association of Aesthetic Plastic Surgeons: Defective implant death prompts review. December 3 2011
- Food and Drug Administration: information on breast implants and ALCL. July 2011