More than two years after a 2019 advisory committee met to discuss long-term risks and benefits of breast implants, the Food and Drug Administration has issued strong safety requirements for all breast implants that include new warning labels and sales restrictions.
Part of this new warning is based on a type of lymphoma called anaplastic large cell lymphoma (ALCL) linked to textured implants that is more common than believed to be. There have been more than 400 reports of patients who have developed ALCL after a breast implant.
Possible cancer risk is not the only warning to be added to this label. It will also inform patients who’ve had breast implants of significant risks which include rupture, infection, or need for reoperation, but also potential for development of an autoimmune disease such as rheumatoid arthritis, Sjogren’s syndrome, scleroderma, and sarcoidosis.
Before this new FDA safety warning regarding breast implants, women seeking breast augmentation and reconstruction were not always counseled or informed of all options and the potential long-term downsides of this procedure. Plastic surgeons, who often are the primary doctors who perform breast augmentation, are happy with this ruling as they advocate all women have a thorough conversation about the risks, benefits, and alternative options.
Part of the FDA ruling is to require breast implant devices to include a boxed warning, in which the potential risks are listed on the product’s packaging. Only healthcare providers who will review the potential health risks and side effects with patients will be allowed to buy them from manufacturers. Patients will also have to complete a decision checklist demonstrating that a healthcare professional has clearly communicated the risks, benefits, and alternatives for breast implants.
Plastic surgeons want their breast implant clients to view this as surgery and that when there is any type of implantable device put into the body, there are potential risks. And as all physicians agree, educating patients making sure they have accurate, up-to-date, and correct information of whatever procedure they are planning to undergo, is the best way to make the right decision for them.