ISAPS Official Statement on Faulty PIP and ROFIL Medro Breast Implants

HANOVER, New Hampshire, January 3, 2012 /PRNewswire/ --

During a recent French governmental inspection of breast implants manufactured by PIP and ROFIL Medro since 2001, health authorities have discovered that most are filled with industrial grade silicone that does not meet the same stringent quality requirements as medical grade silicone. The rupture rate of these implants appears to be five times higher as compared to other implants.  This means that they do not meet legal requirements or industry standards.  Due to the high risk of rupture and subsequent release and distribution of silicone gel, PIP breast implants have been prohibited in Europe since April 2010 where more than 1,000 cases of ruptured PIP breast implants have been reported already. The total number of patients with PIP breast implants is estimated at 30,000. 

The International Society of Aesthetic Plastic Surgery (ISAPS) strongly supports the French recommendation that breast implant patients should check with their doctor or hospital to determine if their implants were manufactured by the French company Poly Implant Prosthesis (PIP) or if they have M-Implants manufactured by ROFIL Medro in the Netherlands. Even without any clinical signs of rupture, these implants should be removed or exchanged immediately to avoid further health risks. 

In a recently conducted study, a connection between PIP breast implants and possible cancers was not detected; however, other medical complications may result from a ruptured implant.  Women with breast implants not manufactured by these two companies are not affected and should feel safe.

The forty-one-year-old International Society of Aesthetic Plastic Surgery is the largest international society of individual board certified (or the equivalent) aesthetic plastic surgeons with more than 2,100 members in 93 countries.  Surgeons undergo a strict application process to determine their qualifications to join the society.  The ISAPS mission is twofold:  the continuing education of plastic surgeons in latest techniques in the field of aesthetic plastic surgery and medicine and the promotion of patient safety.  ISAPS encourages all women with PIP or ROFIL Medro breast implants to check with a specialized plastic surgeon as soon as possible.   All ISAPS members are listed on the website http://www.isaps.org.

For information:
Catherine B. Foss
Executive Director
International Society of Aesthetic Plastic Surgery
45 Lyme Road - Suite 304
Hanover, NH  03755  USA
Tel:  +1-603-643-2325    Fax: +1-603-643-1444
Email - isaps@conmx.net
Web - http://www.isaps.org