Stronger Breast Implants Warning - See What the FDA Says Before your Surgery

Breast implants can change the appearance of a person in a positive manner. They can help you gain a greater size to the breasts as well as change their shape and provide the breast area with a rejuvenated and youthful look. The size of the breast implants placed in the body depends on the desired amount of breast augmentation, the body frame of the patient and the amount of enhancement that can be added while still maintaining a natural look to the treated area. Even though breast implants remain a popular procedure that provide an improved aesthetic look in the area where they are placed in the body, there was a new warning issued by the Food and Drug Administration (FDA) last year you need to know about before your surgery.

Stronger Breast Implants Warning – What Does it Say?

In October of last year, the FDA issued a new warning that required healthcare professionals to effectively communicate the risks and safety issues associated with breast implants. This change comes after testimony in 2019 from women who said their doctor did not give them adequate warning about the potential health complications that are related to having breast implants.

The FDA said it has decided to restrict the sale of breast implants (by manufacturers) to healthcare providers who are shown to offer patients a standardized checklist that explains the risks involved with having breast implants placed in the body. The changes put in place by the Food and Drug Administration require doctors to walk their patients through the potential issues and also give them the chance to sign a checklist that shows they were properly informed about possible risks to their health before they had breast implant surgery.

In addition, the FDA will also require the packaging of breast implants to include a boxed warning which means the potential risks to the patient have to be listed on the packaging of the product.

In general, the new requirements and stronger warning are being issued since many patients were not aware of any earlier warnings about the possible risks and the new rules should help patients and practitioners take warnings more seriously.

Breast Implants – What are the Health Risks?

While you might not experience any of the possible risks listed in this article, there are some you should be aware of before making the decision to have the procedure. These risks include breast implant rupture, infection, the formation of scar tissue around the implant (capsular contracture), joint pain, chronic fatigue, the need for another surgery if you are not happy with the initial size and shape of the results, and cognitive difficulties.

Breast Implants – What are the Types of Breast Implants

In general, there are two types of breast implants used during augmentation mammoplasty to provide an improved shape or size to the breasts. The implants are filled with either silicone or saline (sterile salt water) so they can be placed in the body either behind the breast tissue or under the chest muscle. Once the breast implants are placed in the targeted area in the body, the incision created by the surgeon will be closed with sutures.

New Breast Implants Warning – Why is It Necessary for Patients to Know About the Warning?

One of the reasons patients need to know about this new warning is the fact that breast implant surgery is a surgical procedure, and all surgeries have some associated risks.

In addition, this new guideline was designed to increase patient education and the overall quality of care you receive from a surgeon. Even though there are some risks (as listed above) with having breast implants placed in the body, breast implants are generally considered to be safe. However, that does not mean this new, stronger warning was not necessary.

One of the most important aspects of performing any type of plastic surgery procedure is making sure patients are properly informed and have the necessary information they need to make an educated decision. Up-to-date and relevant patient education helps you enter the consultation process with the necessary information you need to ask questions you want answered by the surgeon.

The new warning is also necessary because, in the past, there were not many restrictions on the type of medical professionals that were able to perform breast augmentation so there was also a broad range of procedure steps from all of these medical professionals.

The stronger warning issued by the FDA will force less vigilant doctors and their practices to either improve their processes or stop them from being able to obtain breast implants from manufacturers.

If you are thinking about having breast implants placed in your body, you need to schedule a consultation appointment with your doctor to discuss both the risks and benefits of the procedure along with learning more about the recovery process. It is also important to make sure the doctor is board-certified and experienced in performing breast implant surgery.

- MA