Latest advice and information for patients with PIP breast implants

Latest advice and information for patients with PIP breast implants

Background

PIP breast implants containing silicone were produced by Poly Implant Prothese, a company founded in 1991 that was based in southern France. For a while, it ranked as the world’s third largest producer of breast implants, supplying around 100,000 implants a year. The implants were shipped all over the world and were used across Europe, Australia and South America. It is estimated that, worldwide, up to 300,000 – 400,000 women might have had these implants (approximately 30,000 in France and 40,000 in the UK).

PIP was placed into liquidation in March 2010 with a loss of 9 million Euros after the French Regulator (AFSSAPS) recalled its implants. An investigation of the company was sparked by surgeons reporting abnormally higher rates of implant failure (leak/ rupture). During a subsequent inspection of its manufacturing site, officials found PIP had started using a type of gel that was not approved by health authorities i.e. a non-medical grade silicone gel filler.

A subsequent investigation found a majority of implants made by PIP since 2001 contained the unapproved gel.

The Murrayfield Hospital – Edinburgh

PIP implants were first used (amongst other implants) at the Murrayfield Hospital in the year 2000. During 2005-2006, a number of cases of unexpected PIP implant ruptures were seen. These were reported to the manufacturing company, its UK distributor as well as the Medical Devices Agency, the then UK regulator. The company did not accept responsibility and its analysis report blamed the implanting surgeons. This prompted a decision to stop using PIP implants at the Murrayfield Hospital in early 2007, three years before the implants were banned by the French authorities.

Approximately 90-95% of procedures using PIP implants in the UK were carried out in private hospitals. The vast majority of these procedures were for cosmetic breast enlargement.

What do we know about PIP implants?

1. Higher than average rupture rates:

The French authorities report a rupture rate of 5% while the UK regulator the MHRA (Medicines and Healthcare products Regulatory Agency) puts the figure at 1%!  The disparity may be explained by variations in the degree of monitoring and reporting. Unfortunately, 5% plus is more in line with our experience in Edinburgh. Some of the failures have occurred within a few years of implantation.

2. Irritant nature of the silicone gel:

Once outside the protective shell (in the case of leak/ rupture), the non-medical grade silicone gel filler used by PIP can migrate causing irritation and inflammation of the surrounding breast tissue. Rupture can also result in breast lump formation (siliconomas) and/ or the enlargement of the adjacent lymph glands (under the armpit).

Follow this link to see the irritant nature of the non medical grade silicone: ruptured PIP implant video

3. No proven link with cancer:

A French expert group found no additional risk of breast cancer for patients with implants in general or PIP implants in particular. The same group did not find any increased risk of an extremely rare lymphatic cancer (ALCL) from the PIP product compared with other implants. It is worth noting that it was a French report of this very rare cancer that sparked the most recent publicity. The UK regulator and professional bodies agree with the findings of the French expert group.

How do women with failed PIP implants present? (symptoms)

1. Implant ruptures/ leaks can remain silent (asymptomatic) for several months/ years

2. Ruptures may be detected after routine ultrasound scan or mammography

3. A patient may experience a dull aching pain or/ and a burning sensation in one or both breasts

4. A change in size/ shape of one or both breasts, especially sudden enlargement

5. The appearance of a breast lump or lumps or enlargement of the lymph glands under the armpit

Please follow the link for a photo presentation on failed PIP breast implants.

For general information on implant rupture please follow this link: breast implant rupture information

It is important to note that a significant number of patients who have had breast implants will, over the years, notice gradual changes in the size, shape and/or feel of their breasts. These changes may happen irrespective of the type and integrity of the implant used. They are worth reporting but they do not necessarily indicate implant failure and might be related to capsular contracture (tightening of scar tissue around an intact implant), fluctuations in weight, pregnancy/ breast feeding or the ageing process.

Recommendations

1. Women who are symptomatic  or have questions about their implants should contact their implanting surgeon or the hospital clinic where their implant surgery was carried out.

2. If the clinical examination and/ or the ultrasound scan point to implant failure then it is recommended that the patient should have both implants removed as soon as possible. Occasionally, an MRI scan is required to confirm or exclude rupture. The following options may be discussed with the patient:

a. Removal of both implants and no other procedure/ implant (explantation).

b. Removal of both implants. The old implants may be replaced with new implants that are comparable to the old ones in size and shape.

c. Removal of both implants. The patient may desire larger or smaller new implants. Additional work to modify the implant pockets might prove necessary.

d. Removal of both implants. The patient may ask for a breast uplift-reshaping (Mastopexy) with or without new implants.

The tissue that surrounds the leaking implant may be removed (Capsulectomy).  Surgical removal of associated breast lumps (siliconomas) and enlarged axillary lymph glands may be considered after careful consideration of pros and cons .

3. Women with intact PIP implants:

Following the publication of the UK government expert review on the 6th January 2012 and the response of the Spire Health Group, we are offering all patients (who had PIP implants at the Spire group) a free consultation, scan and removal of implants with or without replacement. This will all be carried out completely free of charge.

How did the manufacturer Poly Implant Prothese get away with producing sub standard implants?

The company began by manufacturing implants using medical grade silicone. The implants were approved and granted the CE mark of quality needed for sale in Europe. The company then subsequently (probably after 2001) moved to an inferior product using industrial grade silicone. Hospitals and Surgeons used the PIP implants in good faith.

Clear new guidance on PIP breast implants issued for patients and doctors from BAAPS, BAPRAS and the surgical colleges.