ISAPS Official Statement on Faulty PIP and ROFIL Breast Implants
Published: 01 January 2012
Hanover, NH. During a recent French governmental inspection of breast implants manufactured and distributed by PIP and ROFIL Medical Netherlands BV 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. In France, more than 1,000 cases of ruptured PIP breast implants have been reported already. The total number of patients with PIP breast implants in France 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 (IMGHC-TX, IMGHC-MX und IMGHC-LS) manufactured by ROFIL Medical in the Netherlands. Even without any clinical signs of rupture, these implants should be removed or exchanged 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 Medical breast implants to check with a specialized plastic surgeon as soon as possible. All ISAPS members are listed on the website www.isaps.org.
Dirk Richter, MD
Chair, ISAPS Patient Safety Committee
Catherine B. Foss
ISAPS Executive Director