Faulty silicone implants at risk of rupture

An estimated 40,000 British women are said to have received French-made silicone implants that surgeons in the UK have been asked to quarantine. Other women may have had them after travelling abroad for cheaper procedures.

Manufacturers Poly Implant Prothese (PIP) were closed down by French authorities which accused it of fraudulently using a non-approved silicone gel for almost 10 years.
Their abnormally high rupture rate means that they are two times more likely to burst than rival products. Victims of the ruptured implants require surgery to remove them.

Tests are being carried out by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to determine whether the unapproved gel affects the safety of the implants.

France’s health regulatory agency, Afssaps, said it inspected the company’s offices because of an increase of cases of its pre-filled silicone gel implants rupturing.
It discovered the company used ‘a silicone gel different than the one that was reported when it was put on the market’ in 1991.
The agency said it was recalling the implants at issue and recommended that women who have such implants see their surgeons for an examination and get annual ultrasounds.
It also said there is no sign the implants caused ‘different complications than those usually seen with other types of breast implants pre-filled with silicone gel’ - though it said there was a ‘higher frequency of rupture and local inflammatory reactions’.

Consultant plastic surgeon Douglas McGeorge of the British Association of Aesthetic Plastic Surgeons (BAAPS) said PIP implants were not used by members of the Association.
He said ‘These are cheap products that tend to be used by commercial companies and could well be used in women who have gone abroad for surgery.
‘They are attracted by cut-price deals but as ever, you get what you pay for.
‘Mainstream surgeons working in Britain have avoided PIP products because they have a high rupture rate and there have been concerns over the last couple of years about the company.’

BAAPS president Nigel Mercer said ‘Concerned patients should contact their surgeon to find out what implants they have. Only PIP implants are involved and as yet there is no evidence that the gel they contained is harmful and we understand that it will not leak into the body. ‘

By Nina Massey