The FDA Recommends Stronger Warning Labels On Breast Implants to Explain the Risks The FDA released new draft guidelines
for breast implants on Oct. 24. The agency urges manufacturers to add "boxed warning" labels on all saline and silicone gel-filled breast implants. The warning would make manufacturers aware of complications associated with textured breast implants. Those complications include chronic fatigue, joint pain, and a rare type of cancer called breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). The FDA also advises that breast implant manufacturers include a "patient decision checklist" on product labels. It would explain why implants aren't lifelong devices and that 1 in 5 women will need to have them removed within 8 years. A detailed material description listing the types and quantities of chemicals and heavy metals found and released by implants is also recommended. The FDA suggests updating the label's information about screening people with implants for rupturing or tearing. Given the fact that over 300,000 people get breast implants every year, it's time they understand what they're signing up for.