Recentemente, muito tem se falado e publicado a respeito dos implantes de silicone da marca francesa PIP, que havia sido aprovado pela Anvisa e comercializado no Brasil. Estima-se que cerca de 25.000 unidades deste implante tenham sido comercializados no país.
O risco aumentado de ruptura do implante dessa marca e o suposto uso de silicone inapropriado em sua confecção levou a autoridades de vários países do mundo a proibirem a comercialização do mesmo.
O posicionamento do Instituto de Cirurgia Plástica PERFACE, segue a linha e as recomendações da International Society of Plastic Surgery (ISAPS), orientando as pacientes a procurarem o médico ou o serviço no qual foi realizada a cirurgia e verificar se foi utilizado o implante da marca PIP.
Sendo constado o uso deste implante, recomendamos a remoção e troca do mesmo, com o intuito de prevenir futuras complicações.
Apesar da cirurgia de implante de silicone (prótese de mama), atualmente ser uma cirurgia amplamente divulgada e muitas vezes banalizada, ressaltamos e enfatizamos a importância do paciente procurar sempre serviços com cirurgiões credenciados, que utilizem sempre produtos de alta qualidade.
Dr. Fernando Nakamura (cirurgião plástico – diretor do Instituto de Cirurgia Plástica PERFACE)
ISAPS Official Statement on Faulty PIP and ROFIL Breast Implants
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