Study: FDA updates report on risk of lymphoma from breast implants

Contents

STUDY AT A GLANCE

This study is about: 

An update to a previous FDA report on the increased risk of anaplastic large cell lymphoma, a rare type of non-Hodgkin lymphoma, in women who have breast implants.

Why is this FDA report important?

Patients who are making decisions about breast reconstruction or breast augmentation should be informed of any possible link between anaplastic large cell lymphoma (ALCL) and breast implants.  Healthcare providers should also be aware of this link so they can properly monitor women who have breast implants.

Study findings: 

Previously, the FDA had received 359 medical device reports (also known as adverse event reports), including 9 deaths, of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).  Of these:

• 203 involved textured implants; 28 involved smooth implants
• 186 involved silicone implants; 126 involved saline implants

As of September 2017, the FDA had received a total of 414 medical device reports of BIA-ALCL, including the death of nine patients.

• 242 involved textured surfaces; 30 involved smooth surfaces
• 234 involved silicone implants; 179 involved saline implants

While the number of cases of BIA-ALCL has increased, the number of deaths remains the same. It is important to note that most cases occurred in individuals who have textured-surface implants, and that no association has been made between BIA-ALCL and the interior material (saline or silicone) of the implant. Nor is there an association with breast cancer. BIA-ALCL is as likely to occur in women who choose implants for cosmetic reasons as it is in women who choose them for breast reconstruction following a mastectomy.

Recent reports estimate that the lifetime risk of developing BIA-ALCL ranges from between 1 in 3,817 to 1 in 30,000 for women with textured implants.

What does this mean for me?

The FDA no longer recognizes BIA-ALCL as a rare condition (instead, it reports estimated risk).  However, while it is not known how many women currently have breast implants, it is important to note that in the United States an estimated 450,000 women get breast implants each year.  Considering the number of women who receive breast implants, the risk for BIA-ALCL is very low. 

The FDA is still collecting data; as new data is added it may impact current risk estimates. Since the FDA began collecting data, the known risk has increased and this trend may continue as more data comes in. 

Breast implants come in different sizes and shapes, have different types of fillings (silicone or saline) and have either smooth or textured surfaces (shells). BIA-ALCL appears to develop more frequently with textured implants than smooth-surfaced implants. Before getting breast implants, talk to your health care provider about the benefits and risks of both textured-surface and smooth-surfaced implants.

Patients who are concerned about possible long-term complications of implant reconstruction should be aware of alternatives such as flap reconstruction or no reconstruction. If you are interested in alternative options, discuss these with your health care provider.

If you already have breast implants, there is no need to change your routine medical care, and currently, removing breast implants is not currently recommended by the FDA if you do not show signs or symptoms of BIA-ALCL (unless you develop unrelated issues with your breast implants). According to the FDA report, the most common symptom of BIA-ALCL is swelling around the implant, which can occur from 2 to 28 years after surgery. You should also contact your health care provider if you notice redness, pain, lumps or breast asymmetry. 

Note: On 07/25/19, the FDA announced a recall of Allergan BIOCELL textured implants and expanders, due to their association with BIA-ALCL.  On October 27, 2021 the FDA announced stronger guidance on breast implant safety. 

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Posted 4/2/18
 

References 

U.S. Food and Drug Administration. “Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).” Published on March 2018.

FORCE XRAYS. "FDA report claims women with breast implants may be at risk for rare cancer." Published April 17, 2017.
 

Disclosure

FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.