Advice Issued To Breast Implant Surgeons

Main Category: Cosmetic Medicine / Plastic Surgery
Article Date: 01 Apr 2010 - 0:00 PDT

email to a friend   printer friendly   opinions  

The MHRA is today advising breast implant surgeons not to use silicone gel-filled breast implants manufactured by the French company Poly Implant Prothese (PIP).

The MHRA was informed by the French medical device regulatory authority (AFSSAPS) that it has suspended the company's marketing, distribution and export of these products.

AFSSAPS recently carried out an inspection of PIP's manufacturing plant and found that most implants manufactured since 2001 have been filled with an unauthorised silicone gel which differs from the originally approved material.

The MHRA is investigating, in collaboration with AFSSAPS, whether the unapproved gel affects the safety of these implants. AFSSAPS is carrying out tests to establish the level of risk.

The MHRA has today issued a Medical Device Alert to breast implant surgeons and healthcare professionals.

Director of Devices Clinical, Dr Susanne Ludgate said, "Clinicians should not implant these devices and they should quarantine any stock.

"Patients who have concerns about their PIP silicone gel filled breast implants should contact their breast implant surgeon.

"Once we receive further information about the safety of these products, we will provide further advice on patient management, as necessary, when more information is available."

Notes

1. In general, a medical device cannot be marketed in the UK without carrying a CE Mark of Conformity. A CE mark is applied by the manufacturer to denote that the device meets the relevant regulatory requirements and performs as intended. For all but the very lowest risk devices, such as unmedicated bandages, an EC Certificate of Conformity must be obtained from an independent certification organisation, called a Notified Body, before the CE marking can be affixed. The MHRA is responsible for designating UK Notified Bodies and regularly audits them to ensure that they continue to perform to the required standards.

2. The Medical Device Alert can be viewed on the MHRA website.

3. For further information about breast implants, see link to MHRA website section on brest implants.

4. Adverse incidents relating to medical devices can be reported using the MHRA website.

Source
MHRA

• Additional
• References
• Citations