A group of UK plastic surgeons has issued new guidance urging women who have the controversial French breast implants known as Poly Implant Prostheses, or PIPs, to have them checked in the next six months for signs of rupture or weakening.

The British Association of Aesthetic Plastic Surgeons (BAAPS) announced the new guidance on Friday following clarification from the French Society of Plastic, Reconstructive and Aesthetic Surgery (SOFCPRE) who conducted a detailed investigation into France’s controversial PIP implants.

Although PIP implants are not popular with BAAPS members, the not for profit public education organization estimates some 50,000 women in the UK have this type of implant and urges them to undergo an ultrasound scan within the next six months to check for rupture or weakening. If there is, then both implants should be removed, they said.

It is understood that PIPs were one of the cheaper types of implant and SOFCPRE started investigating it after French surgeons reported they were rupturing more frequently than other types.

The investigation found that since 2005, the company that made the PIP implants, which has now gone into administration, stopped applying a protective barrier to the implants. Not only this, but the silicone gel they used in the implant was illegal: it was not the one submitted in premarketing tests required to meet EU consumer safety, health or environmental requirements (the CE test).

According to the BAAPS statement, SOFCPRE asked the gel manufacturers to forward studies on how the altered gel might react with the human body, but they said there weren’t any and understood the material was going to be used in mattresses.

BAAPS President Nigel Mercer, a consultant plastic surgeon, told the media that the investigation concluded the surgeons were not to blame in these cases as they had acted in good faith.

“There was no way of knowing the gel was untested or that the protective envelope, which adds strength and restricts the gel from travelling into the body, had been dispensed with,” said Mercer.

He said there was no serious cause for alarm. The substituted gel is undergoing further tests, and in the meantime he urged women who have had breast augmentation to contact their surgeon and check what type of implant they have.

“If it’s PIP they should have an ultrasound in the next six months to establish whether there is any weakening or rupture. At present removal is recommended in these cases, but if there is one ruptured implant, the contralateral one should be taken out as well, as a preventative measure,” said Mercer.

According to AFSSAPS, the French Health Products Safety Agency, investigations so far show risks to health from having PIP implants are no different than those normally encountered with other types of implants. However, a higher rate of ruptures and local inflammation following ruptures have been observed. These reactions are not serious and the recommended treatment is to have the implants replaced.

In most cases a ruptured implant has no symptoms and the only way to find out is with a clinical examination. AFSSAPS said this was why regular follow up was important.

If there is no rupture, and everything looks fine, the French agency said current information does not justify preventative removal of PIP implants but women with this type of implant should continue to have regular check ups and undergo an ultrasound scan every year.

Source: BAAPS, AFSSAPS.

Written by: Catharine Paddock, PhD