Last month, the US Food And Drug Administration released draft guidance called “Breast Implants- Certain Labeling Recommendations to Improve Patient Communication” that included various recommendations to ensure that patients receiving saline and silicone gel-filled breast implants were completely informed about the product and its risks.
The draft guidance recommends a boxed warning, the strongest FDA warning for prescriptions drug labeling to bring attention to life-threatening risks, as breast implants have been associated with cancer and other illnesses.
The FDA recommends that the boxed warning read: “breast implants are not considered lifetime devices;” “the chance of developing complications increases over time;” “some complications will require more surgery;” or “breast implants have been associated with the risk of developing BIA-ALCL and may be associated with systemic symptoms.”
In 2011, the FDA identified what is known as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
This cancer affects the immune system and is often located in the scar tissue or fluid surrounding the implants.
Symptoms can occur years after surgery and include swelling and pain in the breast implant area. Successful treatment requires surgically removing the implant.
This cancer is largely associated with textured breast implants, which are not as common in the US.
In July, the FDA requested a Class I recall (the most serious recall) of Allergan’s BIOCELL textured breast implants and tissue expanders that were linked to the rare cancer.
The company recalled all of its products worldwide. Patients with Allergan breast implants consisted of 84% of all BIA-ALCL cases worldwide and twelve of the 33 deaths linked to the lymphoma.
Besides cancer, systemic symptoms or Breast Implant Illness (BII) have been reported by patients with both saline and silicone gel-filled implants. These symptoms include memory loss, fatigue, mental fogginess, rash and joint pain.
At a public advisory panel in March, patients who had experienced breast implant related illnesses and cancer came forward about their concerns over the lack of information women receive when deciding on breast augmentation or reconstruction surgery.
Important information is often not communicated to patients, such as the need for breast implant patients to schedule follow-up MRI’s and consistently be monitoring their implants.
One woman at the panel meeting brought up concerns about having children after breast implants, explaining her fears that the illness she experienced from her breast implants may have even caused health complications in her two sons.
The testimonies ultimately sparked the FDA to release this draft guidance, which is currently open for public comment and review.
Along with a boxed warning recommendation, the FDA suggested a patient decision checklist.
It is important to inform patients that breast implants have a lifespan, usually around ten to twenty years, although complications can occur at any time.
Tissue expanders used in breast reconstruction surgery should only remain under the skin or muscle for less than six months.
The longer the implants remain in the body, the greater the risk of complications and illnesses.
Twenty percent of women who undergo breast augmentation surgery experience complications requiring them to have their implants removed within eight to 10 years.
Complications that occur in at least one percent of breast implant patients can include ruptures, inability to breastfeed, breast pain, asymmetry, capsular contracture, calcification, hematoma, inflammation, extrusion, wrinkling, and deflation.
Sometimes complications require additional surgeries, removal, or replacements.
The draft guide also recommends silicone gel-filled breast implant rupture screening recommendations, materials and device descriptions, and a patient device card.
MRI’s are the most effective way to detect ruptures in saline or silicone gel-filled breast implants. Saline and silicone gel-filled implants are the only type of breast implants available in the U.S.
Both have a silicone outer layer, but saline implants are filled with saline on the inside and silicone gel-filled implants are filled with silicone gel.
These implants are placed under breast tissue or the chest muscle to either increase breast size or replace breast tissue.
Rupture happens when the outer silicone layer develops a tear or hole, and deflation happens when a saline breast implant develops a leak.
This can happen naturally from aging of the implant or from physical pressure and rough handling (like during a mammogram or surgical procedure).
It is sometimes noticeable when the breast loses its size or shape, but a “silent rupture” can also occur which is completely undetectable.
The FDA recommends that breast implant patients receive MRI screening three years after the initial surgery and then every two years after that. If rupturing has occurred, the implant must be surgically removed.
Most of the 300,000 women who receive breast implants each year are extremely satisfied.
In 2018, breast augmentation was the most popular cosmetic surgery in the US. However rare a breast implant related disease may be, it is important that patients are completely informed before making this life changing decision.
To remain informed, check out the National Breast Implant Registry.
To report complications with your breast implants go to MedWatch and include the device name, manufacturer’s name, and the details of the complications or any necessary surgical interventions.