The first reported case of implant-associated anaplastic large-cell lymphoma (ALCL) outside the breast is “uniquely unfortunate” and has prompted new concern about the risks of ALCL with textured silicone implants used elsewhere in the body, say experts.
“It is imperative that all physicians recognize that patients with textured silicone implants other than breast implants may also be at risk of ALCL,” says Daniel J. Gould, MD, PhD, from the Keck Hospital of the University of Southern California, Los Angeles, and colleagues, who reported the case.
Patients with textured silicone implants other than breast implants may also be at risk of ALCL.
This rare variant of T-cell non-Hodgkin lymphoma was diagnosed in a 49-year-old woman. She had undergone cosmetic buttock enhancement with bilateral textured silicone gluteal implants 1 year prior to initial presentation with recurrent pleural effusion and abdominal discomfort.
Despite aggressive chemotherapy and resuscitation, the patient died of renal and respiratory failure several months later.
After investigation of a left-sided lung mass and bilateral skin ulceration over the gluteal implants, the findings were suggestive of disseminated ALK-negative gluteal implant-associated ALCL (GIA-ALCL), the authors write.
The case report was published online February 15 in the Aesthetic Surgery Journal.
“Immunohistochemical analysis of aspirated seroma fluid from the implant capsule is still currently the most sensitive screening and diagnostic tool available for assessing patients with textured implants that present with late-onset seroma or other cardinal signs of implant-associated ALCL,” the authors emphasize.
Although the exact nature of breast implant-associated ALCL (BIA-ALCL) pathogenesis has yet to be determined, the chronic biofilm formation on the surface of the implant, particularly those that are textured, leads to inflammation, immune cell activation, and cancer proliferation and transformation, the investigators note.
More than 600 Cases Linked to Breast Implants
As previously reported by Medscape Medical News, most cases of implant-associated ALCL have been reported in women following breast reconstruction or cosmetic enhancement using implants that are textured rather than smooth.
Typically, BIA-ALCL occurs in the capsule around the implant and has a benign clinical course, particularly when the disease is confined to the capsule. In the vast majority of cases to date, diagnosis is made 8 to 10 years after implantation when the patient presents with a late onset lump or fluid around the breast implant.
BIA-ALCL can be effectively treated with implant removal and complete capsulotomy. When it has advanced beyond the breast, chemotherapy is also required.
The number of reported cases of BIA-ALCL has been growing steadily worldwide. On February 6, the US Food and Drug Administration (FDA) said a total of 660 medical device reports (MDRs) had been received on BIA-ALCL cases in the US since 2010. In Europe, French surgeons have called a moratorium on the use of textured breast implants, with prophylactic implant removal in concerned patients.
“Given the concerns that we have, GIA-ALCL is something that has to be explored from a safety perspective,” said Alan Matarasso, MD, president of the American Society of Plastic Surgeons (ASPS), and clinical professor of surgery at Hofstra University/Northwell School of Medicine in Hempstead, New York, when approached for comment.
He also pointed out that so far, only one case has been reported with a gluteal implant, and “one case does not make a series.”
Whether this single case report represents a new form of implant-associated ALCL that would not occur in the breast environment remains to be determined, Matarasso said. It might also be the same rare form of ALCL seen in the general population.
Two things make this gluteal implant case distinctly different from BIA-ALCL, he pointed out. The skin ulceration seen in the buttock area directly over the implants and the rapid onset and aggressive nature of GIA-ALCL are not characteristic of BIA-ALCL, he said.
“It could be related or not. As the authors point out, evidence of causation is lacking,” Matarasso told Medscape Medical News.
If there is any good news, it could be that buttock enhancement is more commonly performed with autologous fat injections rather than with textured silicone gluteal implants, said Matarasso. He noted, however, that sometimes, the two are used together: the gluteal implant for lift and the fat injections for volume.
“In my opinion, any textured implant should be suspect,” said Stafford Broumand, MD, professor of plastic surgery at the Icahn School of Medicine at Mount Sinai in New York City, who was also approached for comment.
“Patients need to be informed and treating physicians need to follow their patients regularly,” said Broumand, who is past-president of the New York State Society of Plastic Surgeons (2013) and has a private practice in New York City.
Broumand said that it is difficult to tell why this presentation of ALCL had such a rapid onset. “Certain texturing techniques are more ‘abrasive’ and can lead more frequently to ALCL,” he noted. “It could be just a variant on a normal presentation of ALCL”
Broumand also pointed out that a single case report does not provide sufficient evidence to change surgical practice, except to encourage the use of smooth implants or autologous fat injections.
Nevertheless, these “new and evolving complications” seen with textured implants are concerning, Broumand told Medscape Medical News. “They have certainly changed my practice of implant placement. We want no risks,” he added.
Reporting and Tracking of Cases
Until more is known, all confirmed cases of BIA-ALCL should be reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, the agency has noted. They should also be reported to the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE) registry at ASPS, and to the implant manufacturer.
The FDA and the ASPS/Plastic Surgery Foundation (PSF) are collaborating to prospectively track BIA-ALCL in the US, said Matarasso.
Gould and coauthors, Matarasso, and Broumand have disclosed no relevant financial relationships.
Aesthet Surg J. Published online February 15, 2019. Abstract