An analysis of 30 years of long-term follow-up data from the Swedish Knee Arthroplasty Register found only a 10% and 26% increase in cancer risk overall among patients with osteoarthritis (OA) and rheumatoid arthritis (RA), respectively.16 However, among patients with RA, knee implant-associated standardized incidence ratios were elevated for lymphoma, myelodysplastic syndromes, and essential thrombocytosis.16

Chromium and cobalt are known to be carcinogenic, but analyses of cancers among 18,235 CoCr-alloy hip implant recipients in Finland suggested no overall elevation in cancer risk for these patients (although the authors outlined a need for continued, long-term follow-up).17,18 

“There are anecdotal reports of people with war injuries involving shrapnel in their lungs – inadvertent implants, of a sort – and they developed tumors in association with those,” Dr Schoen said. “But they’re so rare, so unusual, that it’s very difficult to determine cause and effect. The numbers are far more persuasive with BIA-ALCL.” 

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(In 2005, the US Department of Defense was preparing to replace controversial depleted uranium and lead bullets with tungsten-nickel-cobalt alloy munitions, but military researchers found that the alloy universally caused high-grade, rapidly metastasizing rhabdomyosarcomas in rats.)19

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Implant-associated cancer case ascertainment and reporting might be low, Dr Schoen acknowledged. “They are so rare and they’re encountered randomly, generally by people with no specific interest in understanding the problem.”

But he is skeptical that appreciable reservoirs of nonbreast implant-associated cancers have gone undetected. 

“I think we would have seen a stronger signal in the past, given the number of people who have received implants,” he said. “It’s exceedingly rare.”

However, there now exist universal implant device identifiers with detailed information embedded into a bar code, he added. In principle, he said, that information could be used to build a registry of device-associated tumors. Registries already exist for BIA-ALCL, Dr Gould noted.20 But the epidemiological interrogation of those data is still in its early days. 

Meanwhile, in light of the Allergan recalls, Dr Gould and colleagues have started encountering patients who want to remove their breast implants even though they have had no adverse events or signs of BIA-ALCL. 

“We have patients showing up in offices now asking for removal of these textured implants despite the risk of ALCL being only 1 in 3000 or 0.03%,” he said. “We counsel them that the risk of surgery in general is high and complication risks can be as high as 1 in 100 or 1 in 200. The FDA’s stance is to stop selling them, but we don’t have to remove them. But patients do not think that way. We’re in a tricky time. Biostatistics can be misleading. We don’t want to remove patients’ options simply because of very rare ALCLs.”

But patient-demanded breast implant removals also offer a research opportunity: Dr Gould is seeking USC institutional review board permission to archive and analyze the implants and capsule fluids extracted from healthy patients. 

“In the next 3 to 5 years, we’ll have better infrastructure and data, but it will likely take another 10 years to understand these cases,” Dr Gould said. “In the meantime, we don’t want to trigger mass hysteria. Implants are by and large safe.”


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  3. Hallab NJ, Samelko L, Hammond D. The inflammatory effects of implant particulate shedding: comparison with orthopedic implants. Aesthet Surg J. 2019;39(S1):S36-S48.
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  11. Palraj B, Paturi A, Stone RG, et al. Soft tissue anaplastic large T-cell lymphoma associated with a metallic orthopedic implant: case report and review of the current literature. J Foot Ankle Surg. 2010;49(6):561-564.
  12. Adams JE, Jaffe KA, Lemons JE, Siegal GP. Prosthetic implant associated sarcomas: a case report emphasizing surface evaluation and spectroscopic trace metal analysis. Ann Diagn Pathol. 2003;7(1):35-46.
  13. Kavalar R, Fokter S, Lamovec J. Total hip arthroplasty-related osteogenic osteosarcoma: case report and review of the literature. Eur J Med Res. 2016;21:8. DOI: 10.1186/s40001-016-0203-3
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  15. Wouda RM, Luu SW, Roush JK, Biller DS. Bilateral osteosarcoma associated with metallic implant sites in two dogs. Isr J Vet Med. 2018;73(4):39-44.
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