On Sept. 28, 2020, the U.S. Food and Drug Administration announced that it issued guidance concerning manufacturer labeling recommendations for breast implants to help ensure patients are able to make informed decisions and have an understanding of any risks.

Following information received over the last several years concerning breast implant illness and breast implant-associated anaplastic large cell lymphoma risks, the FDA’s guidance, “Breast Implants — Certain Labeling Recommendations to Improve Patient Communication,” provides specific labeling recommendations to manufacturers so that patients “have the information they need for a balanced discussion with their physicians regarding the benefits and risks of breast implants.”

The guidance suggests manufacturers provide a boxed warning to noticeably communicate the risks associated with breast implant devices, a standardized checklist for patients, and other labeling. The FDA stated that it intends to work with breast implant manufacturers to incorporate the new labeling recommendations.      

What Do the FDA’s Breast Implant Labeling Recommendations Say?

The FDA’s labeling guidance also provides suggestions for content and format so that the information is easy to understand.

As part of the recommendations, the FDA suggests that boxed warnings “would be particularly useful,” specifying that they should provide patients notice about possible complications, BIA-ALCL, and other warnings. A boxed warning would also indicate that breast implants are not considered permanent “lifetime devices” and that they have been associated with certain systemic symptoms — commonly referred to as breast implant illness. 

The FDA’s guidance also indicates that patients should be provided with a “patient decision checklist” to advise them of situations in which implants should not be used, BIA-ALCL and breast implant illness risks, as well as additional information to discuss with their doctor prior to having the procedure. The FDA suggests that the checklist be signed by both doctors and patients to acknowledge the information was discussed.  

Additionally, the FDA recommends labeling requirements for rupture screening, as well as providing patients with a booklet listing the chemicals and materials in the implants, and their potential toxicity.

According to the FDA, the new labeling recommendations are meant to enhance the discussion patients have with their physicians.

Binita Ashar, M.D., Director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, stated in the FDA’s press release, “After working with stakeholders, including patients, today we are recommending format and content changes to breast implant labeling so the information is presented in an easy to understand way. It is important that patients discuss the risks and benefits of breast implants with their health care provider and we hope that these labeling recommendations will help in facilitating these discussions.”

What is Breast Implant Illness?

Some women have had various systemic symptoms appear after breast implant surgery, regardless of the type of implant used. Often known as “breast implant illness,” patients have experienced fatigue, chills, rashes, depression, chest pain, anxiety, gastrointestinal problems, concentration issues, breathing problems, and many other issues.

Breast implant illness symptoms have appeared in women immediately following the procedure, or years later. Some patients reported alleviation of symptoms after the implants were removed.

Although research into breast implant illness is ongoing, some doctors believe that breast implant illness could be related to undiagnosed autoimmune disease in certain patients. However, other women may also be susceptible to systemic problems, without any history of autoimmune disorders.

Are There Other Illnesses Caused by Breast Implants?

The FDA found that textured implants manufactured by the pharmaceutical company, Allergen, are linked to a type of cancer referred to as BIA-ALCL, a form of non-Hodgkin lymphoma not to be confused with breast cancer. Allergan issued a voluntary recall of its BIOCELL line, including Natrelle saline-filled and silicone-filled textured implants, as requested by the FDA.

Common symptoms of BIA-ALCL include hardening of the breast, lumps in the breast or armpit, fluid collection, enlargement, pain, and asymmetry.

Should Patients Have Other Concerns About Breast Implants?

As recommended by the FDA, patients should be educated about the benefits and risks of breast implants prior to the procedure being done. Patients should also ensure that they are adequately informed of the possibility of complications, address health concerns with their doctors, and continue to monitor the implants following their doctor’s instructions.

The FDA states that breast implants are not “lifetime devices,” and there is more possibility for complications the longer patients have them.

Can You File a Lawsuit for Breast Implant Illness?

Patients who developed BIA-ALCL or a breast implant illness may be able to file a lawsuit or join a breast cancer class action lawsuit to recover for their damages. A number of women have recently commenced lawsuits against Allergan in connection with cancer claims and the company’s alleged failure to warn. If you suffered injuries or illness linked to breast implants, an experienced attorney can discuss your legal rights and remedies.

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This article is not legal advice. It is presented
for informational purposes only.