The U.S. Food and Drug Administration (FDA) recently announced that it has received 359 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. Nine of these women died from the disease, which is a rare form of non-Hodgkin’s lymphoma (NHL).
Textured breast implants have been linked to a rare form of non-Hodgkin’s lymphoma, prompting lawsuits by patients.
The vast majority of these cases—203 of 231 that included the surface type—had textured surfaces as opposed to smooth.
According to the Plastic Surgery Foundation, there were 290,647 breast augmentation surgeries in 2016. Worldwide, an estimated 11 million women have implants—which means there could be many more of these BIA-ALCL incidents that have yet to be reported.
Many patients have filed BIA-ALCL lawsuits to recover damages for medical bills, lost wages, and pain and suffering.
Studies Suggest “Increased Risk” of ALCL
The FDA first noted a potential link between breast implants and ALCL in 2011, but at that point it had not received any reported fatalities. It also lacked a strong enough body of evidence to establish a solid connection.
That changed over the past six years, as the agency received more reports of BIA-ALCL, some of them fatal. The incidents were common and concerning enough that the FDA issued a statement, noting
…we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants.
The FDA stated that it would continue to monitor MDRs, to review medical literature and data from the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE Registry), and to collaborate with “international regulators and health experts.”
The FDA states, “All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants.”
This information includes a January 2017 study, which found that the incidence of ALCL in breasts with textured implants is 67.6 times higher than the incidence of breasts with no implants.
Textured implants can reduce the risk of capsular contracture, a condition in which the tissue surrounding the implant(s) hardens. But it seems they bear a new danger in its place.
Dhivya Srinivasa, a plastic surgery resident at the University of Michigan and BIA-ALCL expert, tells NPR, “There’s many kinds of texturing, and different companies do it differently.” For this reason, it’s unclear how or why textured implants might increase the risk of ALCL.
The material of the implants does not seem to affect the incidence rate. Of the 312 FDA reports that included the type of material, 186 were silicone and 126 were saline.
ALCL Is Rare Type of Non-Hodgkin’s Lymphoma
It can take up to ten years for ALCL to develop.
ALCL is not a breast cancer but rather a rare form of non-Hodgkin’s lymphoma (NHL), a T-cell lymphoma. (Lymphoma is a cancer of the blood.) It comprises just one percent of NHL cases and just 16 percent of all T-cell lymphomas, according to the Lymphoma Research Foundation (LRF).
It can take up to ten years for ALCL to develop, which helps explain why it took several years for the FDA to go from a potential link to an established one.
Symptoms of BIA-ALCL may include the following:
- Breast lump or lumps
- Fluid buildup
- Hardening of or mass around the implants
With regard to ALCL treatment options, the LRF says, “If the disease is confined to a single lesion or area, radiation therapy or surgical excision will result in complete remission in approximately 95 percent of patients.”
This echoes the FDA’s statement on BIA-ALCL, which says that the majority of these cases can be treated by removing the breast implant and surrounding tissue. The FDA does note, however, that some patients may also require chemotherapy and radiation.
If you are experiencing any of the symptoms mentioned above, please consult a doctor immediately.
Breast Implant Cancer Lawsuits
BIA-ALCL lawsuits generally make claims for some combination of the following:
- Defective design and/or manufacturing
- Failure to warn
- Punitive damages
- Attorney fees
These lawsuits typically seek compensation for the following damages:
- Medical expenses
- Lost wages (past and future)
- Pain and suffering
In 1994, three breast implant manufacturers—Dow Corning, Bristol-Myers Squibb, and Baxter Healthcare—agreed to pay $3.7 billion to settle lawsuits filed by more than 25,000 women who suffered injuries from their silicone breast implants. At the time, it was the largest class action settlement in history.
In light of these injuries, the FDA severely restricted silicone implants from 1992 to 2006.
For more on breast implant cancer litigation, please see our lawsuit page.