The U.S. Food & Drug Administration (FDA) is frequently criticized for being too strict or too slow on approvals of new medications or medical products. However, setting a high standard and not rushing approvals has protected Americans from potential risks and dangers. It now appears that the FDA made the right call when it followed its advisory panel’s recommendations in not approving PIP breast implants in the United States. The Poly Implant Prothese (PIP) silicone gel breast implants are now being investigated for poor production and high rupture rates in Europe and South America.
As early as 2000, the FDA raised concerns about the French made breast implants, almost 10 years before any regulators in Europe were aware of problems. Based on an FDA inspection, PIP was sent a warning letter pointing out problems in their saline-filled breast implant manufacturing process. The FDA also cited PIP’s failure to investigate the deflation of its saline implants and its failure to report patent complaints.
The PIP saline-filled breast implants were sold in the U.S. starting in 1996 but when the FDA finally required all implant manufacturers to submit a formal application to continue selling their implants, a panel recommended that the FDA reject PIP’s application. The same panel however, recommended that the other two breast implant manufacturers, Inamed (Allerga) and Mentor, have approval for their implants.
As it now turns out, the FDA concerns were correct and American women were spared the potential problems now facing European and South American women. Fortunately, the U.S. breast implant manufacturers, whose implants are currently approved by the FDA, have an excellent track record of saline and silicone gel breast implant production.
- Source: International Business Times
- Copyright: Karol A. Gutowski, M.D., Chicago, IL, 2011