As WJLA reports, in 2011 there were 60 reported cases of Breast Implant-Associated Anaplastic Large Cell Lymphoma (ALCL) worldwide, according to the Food and Drug Administration (FDA). Today there have been 258 confirmed cases of ALCL, 192 unconfirmed cases, and at least 12 deaths.
Forty-year-old Raylene Hollrah’s case is number 25 on a list o f ALCL cases within the United States. As she told WJLA:
“I did everything to keep cancer away. Yet, I put a device in my body that caused cancer.”
In 2008, Hollrah chose textured implants for reconstructive surgery following her battle with breast cancer.
The difference between textured and smooth implants, describes Dr. Dennis Dass’s website is that smooth implants have a smooth surface over a silicone shell, while textured implants have a sand paper like surface over the same shell, like the one pictured below:
— Specialist C Surgery (@SpecialistCSurg) June 20, 2016
Textured implants are favored for being able to limit implant rotation. However, this implant is now at the center of controversy as possibly being linked to cancer.
WJLA reports that in 2011, the FDA cautioned of a possible link between lymphoma (a cancer of the lymphatic system) and breast implants. Following the FDA’s findings, the American Society of Plastic Surgeons took steps to track cases of ALCL by developing a database.
Breast implant manufacturers then began adding warning labels on their product packaging for surgeons, as well as putting the information online for consumers.
However, in 2013 when Hollrah was diagnosed with ACLC after noticing a visible difference in breast size, she claims she had never been warned about the risk.Image Credit: Screenshot/WJLA
She told WJLA:
“No one ever warned me. It makes me mad.”
While conducting their own investigation, WJLA reached out to Dr. Mark Clemens, an expert in ALCL who stated that only one-quarter of surgeons discuss the risk of ALCL with patients.
According to Dr. Clemens, the risk of developing ALCL is low, with the disease affecting about one in 30,000 women in the United States. However, in Australia, the ratio is one out of every 1,000 women, which Dr. Clemens suggests is evidence of serious underreporting.
Dr. David Song, Region Chief of MedStar Plastic Surgery and Chairman of the Department of Plastic Surgery at Georgetown University School of Medicine called ALCL “extremely rare.” In an interview with WJLA when asked if perhaps ALCL is caused when a textured implant rubs against the internal cavity of the patient, he replied:
“We don’t know what creates this lymphoma.”
WJLA reports that many plastic surgeons they interviewed, including Song, expressed concern over “unnecessarily scarring women” in regards ALCL, and thus limiting their choices when it comes to electing breast implant surgery.
However, Dr. Scott Spear, a leading advocate for breast implants told WJLA that although ALCL is rare, he hardly uses textured implants and always discusses the risks with patients.
WJLA interviewed several authorities and experts in the medical field for their investigation including Allergan, the manufacturer of Hollrah’s implants and the name that WJLA claims appears most frequently in “adverse reporting” cases of ALCL.
A written statement from Allergen in response to the outlet’s questions of whether or not textured implants are to blame for ALCL, and what course of action is being pursued to raise awareness, reads in part:
Patient safety is always Allergan’s first priority. However rare, Allergan takes this disease seriously.
According to the FDA, BIA-ALCL has been reported in patients with textured breast implants from all manufacturers. Because of the limited number of confirmed BIA-ALCL case worldwide, the medical community has not been able to establish causality.
Allergan is actively working to help advance the knowledge of this disease, understand the association of BIA-ALCL and textured implants, and educate the community…”
Stephanie Caccomo, a press officer with the FDA told WJLA that the link between textured implants and ALCL is not so clear. A written answer to the outlet’s question on whether there is or there isn’t a link reads:
Some scientists have suggested that a textured surface may be a risk factor for ALCL, but this has not been evaluated in a large, well-designed, epidemiologic study. As of September 2015, of the reports received by the FDA, 50 percent of BIA-ALCL cases are with textured implants … 45 percent do not specify whether they were textured or smooth implants.
The President of the National Center for Health Research, Diana Zuckerman, PhD, told WJLA:
It is not true that textured implants are the only ones associated with BIA-ALCL. [A] summary of a recent medical journal article clearly says that “most women with ALCL have at least one textured implant” but that doesn’t mean they all do. …
Plastic surgeons have generally rejected any studies that report an association between disease and breast implants, and implant companies have paid researchers to publish studies that deny these associations, but there has been evidence of a link to various diseases for at least 15 years, including studies by [National Institutes of Health] NIH and FDA scientists…
Nobody really knows how common BIA-ALCL is. … Unfortunately, like most complications, it is under-reported to the FDA.
The FDA has published a set of recommendations for breast implant patients and health care providers regarding ALCL.
In the wake of her diagnosis, Hollrah started “Just Call Me Ray,” a foundation seeking to spread awareness and offer resources for those concerned about BIA-ACLC.
“I’ve lost my chest,” she tells WJLA, “but not my voice.”