Das amerikanische Gesundheitsministerium bestätigt die Sicherheit von Silikongel-Brustimplantaten

Das amerikanische Gesundheitsministerium bestätigt die Sicherheit von Silikongel-Brustimplantaten

Am 22.Juni 2011 veröffentlichte das amerikanische Gesundheitsministerium (FDA) als Update einen 63seitigen Bericht, der die aktuellen klinischen und wissenschaftlichen Erkenntnisse bezüglich Silikongel-Brustimplantaten behandelt. Der Bericht bestätigt, dass Implantate die mit Silikongel gefüllt sind sicher und effektiv sind, wenn sie wie empfohlen verwendet werden. Anbei die Original-Zusammenfassung des Berichtes sowie die Schlussfolgerung:

Summary of Key Findings

1. Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use.
2. The longer a woman has breast implants, the more likely she is to experience local complications or adverse outcomes. Women with breast implants will need to monitor their breasts for local complications for the rest of their lives.
3. The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement). Other frequent complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection, among others. These observations are consistent with the local complications and adverse outcomes that were known at the time of approval.
4. Women with breast implants may have a very small but increased likelihood of being diagnosed with anaplastic large cell lymphoma.
5. In the post-approval Core Studies, between 20 to 40 percent of augmentation patients and 40 to 70 percent of reconstruction patients had reoperations during the first 8 to 10 years after they received their implants. Although routine replacement is not necessary, many women will need additional surgery to modify, remove, or replace their implants.
6. There is no apparent association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. Associations that are very rare or that take many years to manifest may not be detected using currently available data.
7. MRI continues to be the most effective method of detecting silent (asymptomatic) rupture of silicone gel-filled breast implants.
8. Interpretation of the data from the silicone gel-filled breast implant post-approval studies may be limited by low follow-up rates.
Conclusion
Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use. Manufacturers and physicians should continue to provide balanced and up-to-date information to women considering breast implants to help inform their decisions.

Den Bericht findet man auf der Internetseite der FDA zum Thema: Brustimplantate

erstellt: 18-07-2011 14:43
Geschrieben von Prof. Dr. med. Peter Graf