FDA Issues Fresh Guidelines On Breast Implants

FDA Issues Fresh Guidelines On Breast Implants

Introduction

The U.S. Food and Drug Administration has announced fresh guidelines, including new warning labels and sales restrictions for all breast implants, considering the risks and health complications associated with the products.

As part of the latest safety requirements, the manufacturers of the breast implant are ordered to include a boxed warning on the product. It will alert the users about the risks of using the implant, including rupture, systemic illnesses and a type of cancer. One of the senior FDA officials informed that it is a big step to ensure the safety of these products.

Earlier, in 2019, the advisory committee held a meeting to address the risks associated and benefits of the implant. The meeting was followed by a thorough investigation which concluded that a type of lymphoma is common due to the usage of the implant.

The FDA has even made it mandatory for the patients to review a safety checklist. It will ensure that the patients are aware of the risks, usage and surgical alternatives specifically for mastectomy patients. FDA has mandated the move for the patients as it believes that the safety information on the products packaging box would get disposed of as soon as it is opened which will eventually result in the patients being misinformed.

The agency has even guided about restricting the sales and distribution of breast implants only to doctors and medical facilities. All these measures and guidelines are framed in such a way that none of the product's information is withheld from the patients before getting it implanted.