Women concerned about French-made PIP breast implants can find all the latest NHS information about the issue on this page.
Worries about the implants have emerged since news of a major investigation into them in France was widely covered in the media in December 2011.
It is thought that around 40,000 women in the UK have the implants, with about 95% of them having been provided privately for purely cosmetic reasons.
What’s the problem?
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. Initially reports also linked the implants to a rare form of cancer known as ALCL. This cancer link has been now been firmly discounted by medical experts here and in Europe.
What type of implants are involved?
The implants involved are called Poly Implant Prosthèse (PIP) and were made, starting in 2001, by a French company of the same name.
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.
Do the implants have to be removed early?
Most breast implants need to be removed or replaced after 10-15 years.
An expert committee was set up recently to examine the specific risks associated with PIP implants. It concluded that as yet there was not enough evidence to recommend their early removal.
However, the committee said the NHS would remove and replace the implants without charge if patients that the NHS had operated on remained concerned. The government expects the private sector to follow suit.
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."
How many people are affected?
More than 300,000 PIP implants have been sold globally in 65 countries over the past 12 years. Europe was a major market but more than half of the implants went to South America.
In the UK, 40,000 women are thought to have the implants. Private clinics fitted 95% of these for women seeking cosmetic breast augmentation. The remaining 5% were fitted on the NHS.
The NHS provides breast implants only where there is clinical need. For example, women who have a mastectomy (breast removal surgery) as part of treatment for breast cancer are often offered implants as part of reconstructive surgery.
What happens if I got a PIP implant through the NHS?
Women who received a PIP implant from the NHS will be contacted to let them know they have one.
If you are worried, you should book a consultation with your specialist or GP. 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 and replacement of PIP implants if a woman and her doctor decide that it is the right thing to do. The secretary of state has made clear that patients' concerns must be put first.
What if I got a PIP implant privately?
The following private clinics have said they will replace PIP implants free if clinically necessary: Holly House, Highgate Hospitals, Make Yourself Amazing, Ramsay Health Care, Spire Healthcare, BMI Healthcare, Nuffield Healthcare and HCA International.
If a private clinic that provided PIP implants no longer exists or refuses to help, then, so long as you are entitled to NHS services, the NHS will cover the cost of the removal of PIP implants if your doctor agrees. However, the NHS will not replace implants unless it is clinically necessary.
What’s the evidence around the saftety of PIP implants?
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.
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:
- From the “patchy” 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.
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 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.
SiliconomaA 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
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.
SiliconomaA 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
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 Food and Drug Administration 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.
source: nhs.uk
