FDA over borstprotheses en lymfklierkanker (ALCL): mijn mening
On January 26, 2011 the American Health Authorities have released a safety signal on Anaplastic Large Cell Lymphoma (ALCL) in women with breast implants.
Dr Timmenga:"Het is zeer zeldzaam en het is niet bewezen dat borstprotheses dit veroorzaken. De waarschuwing van de FDA probeert ons daarom gerust te stellen, maar het veroorzaakt natuurlijk het tegenovergestelde. Ik vind dat op z'n zachtst gezegd onverstandig. Bedenk je dat de kans op borstkanker met (of zonder) borstprotheses 1:9 is, en de kans op deze zeldzame aandoening met borstprotheses 1:125.000. Dat betekent dat je je vooral zorgen moet maken over borstkanker, zoals iedere vrouw, maar dat borstprotheses gewoon veilig zijn "
De belangrijkste passages uit de waarschuwing:
The number of patients who developed the disease is extremely small (34 identified cases out of an estimated number of 5 to 10 million women with breast implants).
The FDA is issuing this communication to inform health care providers and the public about a possible association between breast implants and a type of anaplastic large cell lymphoma (ALCL). Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant. The number of identified cases is small compared to the estimated 5 to 10 million women who have received breast implants worldwide. But based on these data, the FDA believes that women with breast implants may have a very small but increased risk of ALCL. Because the risk of ALCL appears very small, FDA believes that the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled. The FDA believes that women with breast implants may have an increased risk of developing ALCL, but also believes any potential risk is extremely low. Due to the rarityof ALCL, the small number of reports, and the incomplete and limited data from these reports, more information is needed to fully understand the possible link between breast implants and ALCL.
