FDA orders stern warning of breast transplant risks | Univision Health News

In some cases, the announcement comes two years after a panel of experts met to discuss the long-term effects of breast implants. Fatigue, joint pain, fatigue, confusion and memory loss, A phenomenon known as ‘breast transplant disease’.

In rare cases difficult breast implants, especially the manufacturer Allergan, which was already on the market at the request of the FDA, are associated with an abnormal type of cancer affecting the immune system.

This sparked a whole movement to demand that there should be an informed approval process for those considering breast augmentation surgery. It is one of the five most popular cosmetic procedures in the country.

Nearly 200,000 carried out in 2020 – 30% less than the previous year- According to American Society for Plastic Surgery.

The new FDA decision, which comes into effect in 30 days, makes it mandatory to add a call ‘Black box alert’, In the packaging of breast implants.

This warning is one of the most rigorous in terms of vision, as it contains black boxes that explicitly warn of potential complications and the fact that prostheses do not last a lifetime.

” The longer a person has it, the more likely they are to have complications, some of which may require another operation.The FDA insists.

The label will also contain the materials used within the implants.

In addition, plastic surgeons should pay for prospective patients Checklist Also review it with them to make sure they are aware of “risks, benefits and other information about breast transplant surgery”, the company warns.

The document in question is those who are ineligible for breast augmentation surgery and which women are at the highest risk for potential complications, as well as those who smoke or undergo chemotherapy or plan to do so. Breast reconstruction after mastitis.

Patients must sign a document acknowledging that breast implants will not last a lifetime and that they will need to have regular checkups if they choose one that is packed with silicone gel, even if there are no symptoms. Under Health Insurance – To detect potential damage that may go unnoticed.

In a statement, FDA spokeswoman Pinita Ashar explained, “The FDA is working to fill in the information gaps for anyone considering breast implant surgery by strengthening safety requirements for manufacturers.”

This decision was applauded by the advocacy groups and experts, although some fear that this is not enough as many surgeons do not take enough time to carefully review detailed documentation with patients.