FDA Considers Black Box Warning in Lieu of Prohibiting Sale of Breast Implants

black box warning, breast implants

After months of conferences and studies on the subject of possibly cancer-causing breast implants, the U.S.  Food and Drug Administration (FDA) announced breast implants linked to anaplastic large-cell lymphoma (ALCL) may continue to be sold in the United States.  To assure the potential risk of these implants is well-known, the agency proposes to issue a black box warning for these types of breast implants.

The Purpose of a Black Box Warning

A black box warning is the most serious and urgent warning the FDA issues regarding any pharmaceutical drug or medical device.  The term “black box” refers to the dark black line that encloses the text of the warning, or a black label instead of the standard white label.

The FDA is considering a black box warning for certain breast implants because these warnings are fairly easy to understand for both physicians and patients.   The presence of the black box warning would essentially be a mandate to physicians to inform patients of the risks of ALCL before breast implant surgery.

Giving Patients Information to Make Informed Decisions

The FDA has pledged to stop allowing breast implant manufacturers to report adverse events via a hidden reporting pathway also known as the hidden FDA database.  Drug and Device Watch has discussed this hidden database at length in our article “Reports of Device Injury Prompt FDA Chief to Release Hidden Database.”.

Although the complete extent of adverse events reported in this way remains unclear, the FDA’s recent statement leaves no doubt that breast implants were among the medical devices whose full danger remain undisclosed to both medical professionals and the American people.

In addition to increased transparency and a black box warning for certain breast implants, the FDA proposes:

  • Mandating a patient decision checklist.
  • Changing the information that manufacturers provide to doctors and patients.
  • Educating pathologists about testing for breast-implant associated large cell lymphoma (BIA-ALCL).
  • An outreach program intended to educate the medical community about BIA-ALCL and other breast-implant risks.
  • Partnering with existing registries currently collecting data on patients with BIA-ALCL.

Breast Implants that Pose a Health Hazard

Breast implants come in two textures – smooth and textured.  About 10 percent of American women who have breast implants have the textured variety.  There have been 265 recorded cases of American women suffering from breast implant-associated lymphoma.  About 20 women have died from the disease.  In most cases of BIA-ALCL, women had textured implants.

Amazingly, the treatment of this type of cancer is primarily the removal of the patient’s breast implants.  In almost every case, the implant removal put the lymphoma into remission, with only a small number of patients needing chemotherapy.

As if the threat of cancer were not enough, the FDA also plans to acknowledge the threat of a little-understood condition known as “breast implant illness” with its black box warning.  Breast implant illness refers to a nebulous set of symptoms that women with breast implants seem to suffer from.  Symptoms completely resolve after the removal of the implants.  These symptoms include:

  • Joint and muscle pain
  • Chronic fatigue
  • Cognitive problems

Though the FDA insists that women should be aware of the risks associated with breast implants, they say their recent investigations do not justify prohibiting use of textured breast implants altogether.  In their statement, the agency says the data doesn’t support a ban for three reasons:

  • The heightened risk is not significant
  • The volume of data is too small
  • It is not possible to definitively exclude smooth implants as a cause as well

What is Breast Implant Illness?

The FDA acknowledges the risk of breast implant illness, but the truth is, the condition is poorly understood.  Women with breast implant illness report symptoms of immune system disease as well as connective tissue disorders like lupus and rheumatoid arthritis.  Women with breast implants also have significantly higher rates of rare autoimmune disorders like Sjogren’s syndrome and scleroderma than the general population.

Researchers have only completed a handful of studies about the illness.  Without a more definitive connection between breast implants and illness, the FDA feels that the block box warning is sufficient to allow women to make up their own minds about the risk which, again, the agency has determined to be slight.

No matter how slight the risk, statistically some women are ill because of their breast implants.  If you have breast implants and are concerned about breast implant illness, talk to your doctor.  More than 10 million women worldwide currently have breast implants, including 400,000 American women who undergo breast implant surgery every year.

The obvious risk factor for breast implant illness is, of course, having breast implants.  Symptoms of breast implant illness and BIA-ALCL do not occur in patients who do not have breast implants.  For women who have implants, the risk is the same whether the patient has the implants for cosmetic reasons or for reconstructive reasons.   The risk is also the same no matter how long the breast implants have been in place.  Symptoms can appear shortly after the surgery or many years later.

Learn More about the Possible Breast Implant Black Box Warning

If you are suffering from the symptoms of breast implant illness, or are concerned about cancer, you may find it helpful to consult an attorney to learn more about your rights.  As a patient and consumer, you have the right to be informed about possible risks and side effects of medical devices.  Unfortunately, many women have gotten breast implants without knowledge of these risks.

If you are one of those women, contact Drug and Device Watch.  Our legal team has been following the FDA’s reports about breast implants and related risks closely.  If you have questions or concerns, we can help.  Call 1-888-458-6825 for more information or to schedule a consultation with an attorney.  You can also contact us via our online form.  Our consultations are always free.