WASHINGTON (AP) – Consumer safety advocates are questioning the Food and Drug Administration about incomplete and seemingly erroneous data used to support the safety of silicone breast implants in an agency review last year.
The FDA concluded last summer that silicone-gel implants are basically safe as long as women understand they come with complications. The agency reported that one in five women who get implants for breast enhancement will need to have them replaced within five years.
The National Research Center for Women and Families issued a letter asking why the FDA did not present information showing that women reported lower emotional, mental and physical well-being after implantation. Additionally, the group questions why figures submitted by implant manufacturers appear to show implant complications declining over time. Implants are known to fail over time.