News

UK recommends PIP breast implants should not be removed

BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d8313 (Published 22 December 2011) Cite this as: BMJ 2011;343:d8313
  1. Adrian O’Dowd
  1. 1London

The UK’s drug regulatory body has recommended that women who have been implanted with Poly Implant Prosthese (PIP) breast implants should not have them removed, despite concerns raised in France.

The French regulatory authority AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé) is expected to issue a statement on 23 December on the safety of the implants, after reports of the death of a woman who had this type of implant from anaplastic large cell lymphoma.

However, in the UK, the Medicines and Healthcare products Regulatory Agency has played down fears saying that it has been monitoring the safety of the implants and has concluded there is currently no evidence to support routine removal of them. The agency says it estimates about 1% of women in the UK with these implants have experienced implant failure.

The company PIP went into administration last year and the use of its implants was banned amid concerns that it may have used non-medical grade silicon to make the implants.

Fears emerged when France’s director general for health, Dr Jean-Yves Grall, told the Liberation newspaper that there had been eight cases of cancer reported in patients with these implants and another patient had died of cancer last year.

However, France’s National Cancer Institute said the cases were not necessarily linked to faulty implants.

There is speculation that the French government could recommend that all of these implants be removed from the 30 000 women in France who have had them.

Around 40 000 of these implants have been used for breast reconstruction or breast enlargements in the UK during operations between 2001 and 2010. This is a small proportion of the breast implants used overall.

The Medicines and Healthcare products Regulatory Agency said it had been monitoring different aspects of PIP breast implant safety since the French regulators identified a problem with manufacturing standards a year ago.

The agency has had discussions this week with other health or regulatory experts from France, the Netherlands, Portugal, Italy, Ireland, Hungary, Austria, Denmark, and Malta.

They all agreed that there was no evidence of any increase in incidents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates other than in France.

Information obtained from the Australian Regulatory Authority (TGA) is consistent with the figures from all these European countries other than France in terms of rupture.

An agency spokeswoman told the BMJ: “If new evidence comes to light, we will consider it as a priority, but at the moment, there is no evidence to suggest routine removal of these PIP implants. We continue to liaise with AFSSAPS.”

The British Association for Plastic, Reconstructive and Aesthetic Surgeons said women should not panic and advised anyone worried about the issue to contact their implanting surgeon.

An association spokesman said: “PIP implants are a small proportion of all breast implants used in the UK and the French company manufacturing them was shut down last year.

“Surgeons will be in contact with any patient who has received this type of implant if any action is required.”

The British Association of Aesthetic Plastic Surgeons also urged caution and its president Fazel Fatah said: “There has been no new scientific evidence to indicate that these implants have a link to cancer.”

Notes

Cite this as: BMJ 2011;343:d8313

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