Warnings of Elevated Lymphoma Risk in Women With Textured Breast Implants

Since breast implants were initially introduced onto the market in the 1960s, issues concerning their safety have been debated ever since. The controversy about their safety even led to a 14 year ban by the Federal Drug Administration (FDA) on silicone gel implants for cosmetic enhancement (1992-2006). Today, the most popular type of cosmetic surgical procedure in the U.S. is breast augmentation, with a number of these procedures and associated implant-based reconstruction increasing every year.

2011 FDA warning about textured breast implants and ALCL

In 2011, the FDA issued an announcement that explained a possible connection between certain types of breast implants and anaplastic large-cell lymphoma (ALCL). Since the announcement, concerns over this rare form of non-Hodgkin’s lymphoma have persisted and grown.

In 2016, the World Health Organization placed ALCL (BIA-ALCL) into a revised lymphoma neoplasm classification as a new disease entity. It described the disease as a buildup of seroma fluid between the breast implant and the fibrous capsule surrounding the implant.

In March 2017, the FDA published an update that revealed 359 reported deaths, including nine patient deaths associated with BIA-ALCL. The agency also revealed that most of the confirmed cases of the condition occurred in women with textured breast implants as opposed to smooth surfaced implants. By September 2017, according to the FDA, the number of BIA-ALCL cases increased to 414, a jump of 15 percent within six months.

2017 JAMA review suggests BIA-ALCL misunderstood and underreported

A review published in JAMA Surgery in 2017 indicated that occurrences of BIA-ALCL are increasing and most likely underreported. The underreporting, according to the authors, was due to basic limitations in worldwide reporting as well as the absence of a global breast implant database.

The researchers pointed to the fact that most of the BIA-ALCL cases are connected to textured implants with a somewhat rough surface designed to maintain the implant’s position. The connection was suggested due to the fact that no occurrences of the condition prior to the introduction of textured implants have been found – however, more research is required.

Researchers believe that BIA-ALCL occurs due to inflammation around the breast implant. Tissue that grows into the minute holes in the textured implant may prolong the occurrence of such inflammation. The conclusion is based on past research that has shown a connection between the occurrence of lymphoma and chronic inflammation. The feature of these implants that facilitates the onset of lymphoma may put such implants into the category of a defective medical device.

2018 study in JAMA Oncology highlights breast implant cancer risk

In early 2018 the medical journal JAMA Oncology published another study that supported the contention that textured breast implants are linked to BIA-ALCL.  Researchers found a causal connection between this form of cancer and the textured breast implants, although the overall risk remains small. They examined data from a Dutch nationwide pathology registry covering the years 1990 to 2016. From this data, which included patients’ ages, breast implant status and various types of breast lymphoma, they found 32 out of 43 patients with breast-ALCL had breast implants. The vast majority – 82 percent – of these patients had textured implants.

If you or a loved one is suffering from a condition of non-Hodgkin’s lymphoma of the breast or ALCL as a result of breast implants, we want to help. Our experienced medical device attorneys at McGowan, Hood, Felder & Phillips, LLC, are able to review your case and fight for the financial compensation you are owed for your injuries. To set up a free case review, give our legal team a call today at 803-327-7800 or complete our contact form.