New FDA Black Box Warning for Breast Implants

The FDA has issued a black box warning on breast implant packaging. The health care provider should review the risk and complications that can be associated with breast implants.  As with all surgical procedures, the patient should have informed consent and understand possible risks and complications.  This FDA black box warning includes a checklist of possible risks and complications associated with breast implants. This is an initial step in helping the patient understand the possible risks and complications.  

What Are The Symptoms of Breast Implant Illness?

Many of the symptoms that have been linked with breast implants fall under a general term called breast implant illness.   This consists of a variety of symptoms that could include brain fogginess, joint pain and fatigue to name a few.  At the present time, there is no specific test for patients that will inform them if they are at risk for some of these symptoms. The majority of patients that have breast implants do not experience these problems but those that do can have a myriad of symptoms. Large cell anaplastic lymphoma is a rare cancer that had been associated with textured breast implants from a specific manufacturer. Those specific implants are no longer on the market.

What Does A FDA Black Box Warning Mean?

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The present checklist associated with the FDA black box warning for breast implants is helping the patient become more informed. Also included in the checklist are a list of medical conditions that can be associated with unfavorable outcomes with breast implant placement. This new warning will also stress that breast implants will not last a lifetime which may require future surgery.  The rupture rate of breast implants does increase after ten years.

In summary this new FDA black box warning for breast implants is a start in helping the patient understand possible risks and complications associated with breast implants no matter how large or small. Many patients undergo successful breast augmentation and breast reconstruction without any significant problems. There is a percentage of patients that do have problems and all patients should be made aware of the possible risks and complications.