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. Implants made earlier by the firm are not thought to be affected.

In a Medical Device Alert in March 2010, the Medical and Healthcare products Regulatory Agency (MHRA) said: ” … most
breast implants manufactured by the company since 2001 have been filled with a silicone gel with a composition different from that approved”.

It is reported that the company had started using a cheap type of silicone gel intended for making mattresses. The marketing, distribution and use of the PIP implants was suspended in March 2010.

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. For more details of its findings read the expert review group’s report (PDF, 159kb).

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.”

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 (MYA Cosmetic Surgery), Ramsay Health Care, Spire Healthcare, BMI Healthcare, Nuffield Healthcare and HCA International. The Transform medical group has said it will remove the implants free for its patients who had them fitted since 2001 and The Hospital Group said it would offer free removal to patients it operated on from 2001-2009; both will charge for replacements.

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 there is a clinical need. This would not include the replacement of private cosmetic implants.

What’s the evidence around the safety 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 effect.

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

If you have any of the following signs or symptoms, you should discuss them with your GP, who will refer you to a specialist:

• lumpiness of the breast
• lumpiness or swelling in the area around the breast
• change in shape of the breast
• deflation of the breast
• redness
• tenderness of the breast
• swelling of the breast
• pain or sensitivity

Dame Sally Davies, The Chief Medical Officer for England, has issued GPs and surgeons with dedicated guidance on checking symptoms in women with PIP implants (PDF, 119kb).

Is the situation being investigated further?

Yes, the Department of Health has set up two reviews to look at how the PIP situation occurred and the issue of regulating the cosmetic surgery industry as a whole.

The first review will be led by Lord Howe and will address a number of specific issues, including:

• what information about PIP implants was available from routine systems for reporting adverse events
• what external concerns about PIP implants were brought to the attention of regulators, and when
• how these concerns and any related information were handled
• what information was shared between MHRA and counterpart agencies abroad
• what action was taken to safeguard and advise patients
• whether action was sufficiently prompt and appropriate

The report is due to be submitted to the health secretary by the end of March 2012.

The second review will look at whether the cosmetic surgery industry needs to be regulated and, if so, how this should happen. It will be led by Professor Sir Bruce Keogh, the NHS Medical Director, who said:

“I am working with experts from the plastic surgery field to look at what we can do to make sure people who choose to have cosmetic surgery and other cosmetic procedures are safe.

“I will be looking at all aspects of regulation – at the regulation of implants and fillers, at whether the people who carry out cosmetic interventions have the right skills, at whether the clinics look after the care and welfare of their patients.”

The extensive report is due to be submitted by March 2013.

In France, Jean-Claude Mas, head of the now-defunct Poly Implant Prosthèse, has been charged with causing involuntary injury. He was released on bail after being arrested on January 26.

 Are silicone implants banned in the US?

Although there have been television reports suggesting the US has ‘banned silicone implants’, this is not accurate. Silicone implants are currently approved and readily available for women who want them, although they must be enrolled into studies to collect data about the performance and safety of their implants.

In 1992 the US Food and Drug Administration (FDA), a regulatory agency equivalent to the MHRA in the UK, temporarily restricted the use of all silicone gel breast implants, but not due to evidence of specific dangers. Instead this was because the FDA felt it required more evidence supporting their safety.

After this, manufacturers were required to submit data on the safety and effectiveness of their implants in an application to market them. Between 1992 and 2006 silicone implants in the US could be used only for reconstruction following cancer surgery, for example, and for replacement of existing implants. Saline (salt water) implants were commonly used instead. In 2006 the FDA again approved silicone gel breast implants for wider use, saying that the benefits and risks were sufficiently understood to enable women to make an informed choice.

However, the FDA recognised that information on long-term safety and rare events was still lacking. To better understand this, the FDA currently requires manufacturers to enrol women receiving their implants into six types of studies, called “post-approval studies”. These studies collect data on long-term effects and rare events associated with the implant. Manufacturers are also required to monitor causes of failure and to conduct studies looking at the acceptability and readability of patient labelling.

In June 2011 the FDA published an extensive document explaining the US position on silicone implants (PDF, 1.45Mb).

Lotus Medical International’s Response

There has been a lot of media coverage recently regarding the French brand of PIP Breast Implants and how they have been removed from the marketplace due to safety concerns. Our surgeons use a brand of Breast Implants called Mentor. This is an American brand and all of our Implants are imported to Thailand from the USA. The Mentor brand of Implants are said to be the best in the world. There have never been any safety issues reported with this brand of implant.