The Food and Drug Administration (FDA) recently drafted new guidelines about the safety of breast implants. The FDA created these guidelines to make sure women know all the risks of breast implants, which include cancer and other illnesses. See what the FDA recommended below.
FDA Breast Implant Guidance
In October 2019, the FDA released a draft of new guidelines related to breast implants and their possible dangers. The guidelines call on manufacturers to provide more information about the risks of breast implants to keep women safe.
The FDA drafted these new guidelines after reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), or breast implant cancer.
BIA-ALCL is a type of non-Hodgkin’s lymphoma, a cancer of the immune system. It is most commonly found in the scar tissue and fluid near breast implants.
Though often treatable, BIA-ALCL can sometimes spread throughout the body and lead to deadly outcomes.
The FDA’s draft guidelines suggest that manufacturers provide:
- Boxed warnings: The FDA uses boxed warnings to alert people to a product’s possibly life-threatening health risks. The agency now recommends breast implant manufacturers use boxed warnings due to the risk of BIA-ALCL.
- Brochures and booklets: Manufacturers should provide informative booklets about breast implants to patients considering them.
- Patient decision checklists: The FDA recommends that patient checklists should be included in every breast implant information booklet. Patients can use these checklists to see if getting breast implants is the best choice for them.
- Patient device cards: Doctors should give a device card to patients who get breast implants. This card gives information about the specific breast implant the patient received. Manufacturers should properly label the card so that it can be found without any trouble.
The FDA’s new guidelines have not been finalized as of June 2020, and the agency is currently accepting public comments about them.
At this time, the proposed guidelines are only recommendations, not rules. The FDA will make an announcement when these guidelines are finalized.
What to Consider Before Getting Breast Implants
The decision to get breast implants is made for different reasons.
Breast implant surgery is performed to:
- Correct breasts that failed to develop properly
- Improve results of a previous surgery
- Increase breast size
- Replace tissue that was removed due to cancer or trauma
Whatever the reason for considering breast implants, the decision should be taken seriously as it puts patients at risk of BIA-ALCL and other health issues.
In fact, the FDA has identified more than two dozen complications associated with breast implants.
These complications include:
- Breast asymmetry
- Breast pain
- Breast implant illness (BII)
- Buildup of blood near the implant (hematoma)
- Deformity of the chest wall
- Fluid collection near the implant (seroma)
- Inability to breastfeed
- Sagging of the breasts
- Skin or nipple sensitivity
- Tissue damage
- Toxic shock syndrome
While these issues do not affect everyone who gets breast implants, they should not be taken lightly. This is precisely why the FDA drafted its new rules — so that women can fully understand the risks before getting implants.
Other Risks of Breast Implants
Life-threatening health problems are not the only risk that breast implants pose. The FDA’s draft guidelines lists several other factors patients should consider before receiving implants.
These additional factors include:
- Follow-up surgeries: Since breast implants don’t last a lifetime, patients may have to receive extra surgeries to replace old implants or if there are complications
- Added expenses: Insurance may not cover removal or replacement of breast implants, even if there are complications
- Implant monitoring: Implants must be monitored for the entire time that they are in the body, possibly through MRIs or ultrasounds for those with silicone implants
- Post-removal complications: If a breast implant must be removed, natural breasts may become wrinkled, dimpled, or puckered
Patients should talk to their doctors about all the possible risks of BIA-ALCL before getting any breast implants.
FDA Breast Implant Guidance for BIA-ALCL
To keep women as safe as possible, the FDA’s draft guidelines state that anyone with breast implants should know the most common symptoms of BIA-ALCL.
These symptoms include:
- Fatigue, memory loss, or brain fog
- Joint pain
- Presence of a mass or pain near the implant
The FDA’s draft guidelines suggest that patients should talk with their healthcare provider if any of these symptoms appear.
Doctors can then test for BIA-ALCL using:
- Physical exams
- Diagnostic imaging tests
- Fluid or tissue assessments (biopsies)
If accepted, the FDA’s guidelines will recommend that patients with BIA-ALCL should have their implants removed.
The FDA notes that patients who do not have symptoms of BIA-ALCL (or other health problems) do not need to have their implants removed.
Until the FDA’s new guidelines go into effect, patients should speak with their doctors to fully understand the risks of breast implants — including BIA-ALCL.