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.”
(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
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.”
- Chavkin S. FDA kept hundreds of thousands of breast implant incidents hidden from public. International Consortium of Investigative Journalists. March 25, 2019.
- Popplewell L, Chang K, Olevsky O, Nademanee A, Forman S. Primary anaplastic large cell lymphoma of the breast occurring in patients with silicone breast implants. Blood. 2004;104(Suppl. 1): Abstract 4563.
- 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.
- Coroneos CJ, Selber JC, Offodile AC 2nd, Butler CE, Clemens MW. US FDA breast implant postapproval studies: long-term outcomes in 99,993 patients. Ann Surg. 2019;269(1):30-36.
- Shauly O, Gould DJ, Siddiqi I, Patel KM, Carey J. The first reported case of gluteal implant-associated anaplastic large cell lymphoma (ALCL). Aesthet Surg J. 2019;39(7):NP253-NP258.
- Menter T, Ballova V, Caspar C, et al. ALK-negative anaplastic large cell lymphoma arising in the thrombus of an aortic prosthesis preceded by clonally related lymphomatoid papulosis. Virchows Arch. 2019. DOI: 10.1007/s00428-019-02531-x
- Manikkam Umakanthan J, McBride C, Greiner T, et al. Bariatric Implant-Associated Anaplastic Large-Cell Lymphoma. J Oncol Pract. 2017;13(12):838-839. doi: 10.1200/JOP.2017.026153
- Yoon HJ, Choe JY, Jeon YK. Mucosal CD30-positive T-cell lymphoproliferative disorder arising in the oral cavity following dental implants: report of the first case. Int J Surg Pathol. 2015;23(8):656-661.
- Tuck M, Lim J, Lucar J, Benator D. Anaplastic large cell lymphoma masquerading as osteomyelitis of the shoulder: an uncommon presentation. BMJ Case Rep. 2016:bcr2016217317.
- Brabyn PJ, Naval L, Zylberberg I, Muñoz-Guerra MF. Oral squamous cell carcinoma after dental implant treatment. Rev Esp Cir Oral Maxilofac. 2018;40(4):176-186.
- 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.
- 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.
- 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
- Levasic V, Milosev I, Zadnik V. Risk of cancer after primary total hip replacement: the influence of bearings, cementation and the material of the stem: a retrospective cohort study of 8,343 patients with 9 years average follow-up from Valdoltra Orthopaedic Hospital, Slovenia. Acta Orthopaed. 2018;89(2):234-239.
- 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.
- Wagner P, Olsson H, Lidgren L, Robertsson O, Ranstam J. Increased cancer risks among arthroplasty patients: 30 year follow-up of the Swedish Knee Arthroplasty Register. Eur J Cancer. 2011;47:1061-1071.
- Makela KT, Visuri T, Pulkkinen P, et al. Risk of cancer with metal-on-metal hip replacements: population based study. BMJ. 2012;345:e4646.
- Ekman E, Laaksonen I, Eskelinen A, et al. Midterm risk of cancer with metal-on-metal hip replacements not increased in a Finnish population. Acta Orthop. 2018;89(5):575-579.
- Furlow B. Alternative to depleted uranium is carcinogenic in rats. Lancet Oncol. 2005;6(4):198.
- McCarthy CM, Loyo-Berrios N, Qureshi A, et al. Patient registry and outcomes for breast implants and anaplastic large cell lymphoma etiology and epidemiology (PROFILE): Initial report of findings, 2012-2018. Plast Reconstr Surg. 2019;143(3S):65S-73S. DOI: 10.1097/PRS.0000000000005571