PIP implants should be removed for preventative reasons

Tuesday, June 04, 2013

Breast implants manufactured by Poly Implant Prothèse (PIP) have a poorer mechanical durability and, in a number of cases, contain an irritant substance in significantly higher levels than other silicone breast implants. The Medical Products Agency and the National Board of Health and Welfare therefore recommend that clinics that have, in the past, used PIP implants inform the women affected of these risks and also that PIP implants should be removed for preventative reasons, except in individual cases where there are medical reasons for not doing so.

The Medical Products Agency implemented a ban on the use of breast implants from the manufacturer Poly Implant Prothèse in March 2010. Approximately 4,000 women had, by then, received PIP implants in Sweden. The global figure is estimated at about 400,000.

The Medical Products Agency has collected, analysed and evaluated PIP implants in order to assess the risks and potential health effects. PIP implants have been shown to have an inferior mechanical durability, which increases the risk of ruptures, compared with silicone breast implants from other manufacturers. The analyses have shown that there are two types of PIP implants, made of different types of silicone. One of the types of silicone contains an irritant substance, octamethylcyclotetrasiloxane (D4), in significantly higher concentrations than present in other silicone breast implants on the market. It is impossible to exclude the leak of D4 from the PIP implants into the surrounding tissues as the cause of local inflammation. It is not possible, with any certainty, to identify which type of silicone is in any one woman's PIP implants. 
 
The Medical Products Agency has compiled the limited data provided by clinics that have removed ruptured PIP implants of the type that contains a higher concentration of D4. The results indicate that there are signs of inflammation in the tissues of about one third of cases. Signs of tissue inflammation have also been found in connection with intact PIP implants that have been removed from women who did not have any symptoms.  

Based on what we currently know, the Medical Products Agency and the National Board of Health and Welfare have assessed that PIP implants should be removed for preventative reasons, except in individual cases where there are medical reasons for not doing so. The authorities can see no immediate health risk associated with PIP implants, but, even if there are no symptoms caused by the PIP implants, it is recommended that they should be removed as a precautionary measure. The controlled, preventative removal of PIP implants carries with it a lower risk than if they are removed once they have ruptured or once inflammation and/or swollen lymph nodes have developed.

The new, altered recommendations from the Medical Products Agency and the National Board of Health and Welfare also include the advice that the clinics should contact women who have received PIP implants to bring them up-to-date about what is known. Those women who choose not to have their PIP implants removed should be told to be aware of the signs of a ruptured implant or inflammation, for example, change to the shape of the breast, lumps, pain, swelling, swollen lymph nodes in or around the breast and armpit, and to contact their doctor should these appear.

BACKGROUND
On 31 March 2010, the Medical Products Agency decided to ban the silicone gel-filled breast implants from the French company Poly Implant Prothèse. The French governmental agency Afssaps had found that the silicone gel which was used in the product differed from that which was listed in the technical documentation.
 
Approximately 4,000 women had, by then, received PIP implants in Sweden. The global figure is estimated at about 400,000. The French manufacturer has, following the ban, gone bankrupt, which has made the investigation into the products and their use more difficult.
 
In November 2010, the National Board of Health and Welfare and the Medical Products Agency recommended that those who had used the implants in Sweden from 2001 inform their patients about the risks and offer an appointment with a doctor.

 

 

Please note the news item’s date of publishing. The Medical Products Agency does not update news.

 

Associated information

 Recommendation

 www.mpa.se/pip (In Swedish)

 

Contact us

Vendela Schnittger
Medical Doctor, Clinical Investigator
Medical Products Agency
 +46 (0)18-17 46 14

Anette Richardson
Head of Unit at the National Board of Heath and Welfare's Department for Knowledge Based Policy and Guidance
+46 (0)75-247 38 43

Christina Branting Ekenbäck
Head of the Regulatory Group
Medical Products Agency
+46 (0)18-18 36 27

   
 

Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | phone: +46 18 174600, fax: +46 18 548566 | Contact information