FDA, Sixth World Biomaterials Conference. May 18, 2000.
FDA has recently completed a study on how often women who had breast implants had to go back to their surgeons for additional surgery on their breast(s). The study was presented at the Sixth World Biomaterials Congress on May 18, 2000.
The study, performed in Birmingham, Alabama, involved women who had their first breast implant before 1988. The majority of women in this study had silicone gel-filled breast implants. Women responded to a telephone questionnaire in which they described past surgeries and whether or not their implants were found to be ruptured after the surgeries. Women also responded to questions about the reason they had the surgery.
The Institute of Medicine recently released its report on the safety of silicone breast implants. It concluded that the primary problems with silicone implants were local complications, including implant removal, ruptures, deflations, capsular contracture, infection, and pain.
FDA conducted this study because of concerns about the frequency and results of rupture. Rupture is a concern because:
- Rupture of silicone gel-filled implants may allow silicone to migrate through the tissues. The relationship of free silicone to development or progression of disease is unknown.
- Rupture is a device failure – the implant is no longer performing as intended.
Read the full study here.