PIP A Medical Experts View

By Mr Adrian Richards MBBS MSc FRCS (Plast.) of Aurora Clinics 

Aurora Clinics never used PIP implants, but have been helping many of the unfortunate 30,000-40,000 reported women in the UK who have these fragile and potentially unsafe implants. Aurora have also produced advice guides for patients, surgeons and GPs to help them understand the complexities of dealing with PIPs. Here are some key observations and recommendations that Aurora Clinics have been making:

Recurring problems with PIP implants

The recurrent problems that our surgeons witness when removing PIP implants are with the implant shell and the implant contents.

The shell of every silicone implant is made through a separate dipping and drying process. In PIPs, it appears that the numbers of dips was reduced; in particular the most expensive layer, which seals the shell from the internal silicone, may have been omitted entirely. This means that the implant is permeable to the internal silicone, resulting in ‘bleed’ of the internal silicone through the shell. This is by far the most common PIP problem that we are noting when women come for removal and in some cases it is so severe that, whilst the shell itself is still intact, virtually the entire content has bled out.

This content is acknowledged to be industrial grade silicone, which is less expensive and has not been tested on humans. Medical grade silicone is expensive and has been tested internally on humans. It appears that, to reduce costs, a mixture of both types of silicone was used in PIP implants. Ongoing toxicology studies are being performed on this silicone but we do not have any definitive data on this at present.

In addition, the actual shell of PIP implants appears to be more fragile than other implant brands, with a higher rupture rate.

Findings

One of the reasons why definitive data is lacking on PIP issues is that there is no national registry of these implants.  A registry did exist but the government withdrew funding for this in the mid 2000s.

Because of this, we do not know exactly how many PIP implants were used in the UK or which women have them.  The government is now calling for the breast implant registry to be re-established.

Aurora Clinic’s surgeons are working with major professional bodies, BAAPS and BAPRAS, to record data on the PIP implants we remove.

Our findings to date indicate that of the PIP implants we have removed:

• 25% are severely ruptured.

• 70% have significant silicone gel-bleed on their surfaces.

• 5% are in a similar condition to other implant brands when removed.

We acknowledge that this is a slightly skewed result as the people I am seeing are more likely to have problems with their implants as they are having surgery.  However, it is showing that the vast majority have a gel-bleed or rupture. Further analysis of the performance of particular batches of PIP implants is ongoing. Many of the implants that have ruptured have only been inserted within the last 4 years.

Recommendations

Because of these findings, we feel that all women with PIP implants should consider having them removed.

If women with PIP implants do not have information on their implant manufacturer they should request this from the surgeon or company who inserted them. This should be provided promptly and efficiently.

The requested information should include the:

Size in CCs.

Type (high, ultrahigh (UH) etc.)

The batch and lot number. The batch number is a 5 digit number and the lot number a 3 digit number.