Incidence of implant-associated lymphoma from textured Implants may be higher than expected

There are two types of white blood cells that make up our immune system. One is called a T cell and the other a B cell. Both cells are called lymphocytes. Both are important to our immune system. Whereas B cells produce antibodies against diseased cells, T cells directly destroy bacteria and viruses that are invading the body. The overgrowth of either of these cells can cause cancer, called lymphoma. An overgrowth of B cells causes a B-cell lymphoma whereas an overgrowth of T cells causes a T-cell lymphoma. In 1997 the first case of a T-cell lymphoma associated with the implant around a silicone capsule was first described by JA Keech and BJ Creech in the Journal of Plastic and Reconstructive Surgery. This first case was described in a 41-year-old woman who developed a T-cell lymphoma in the fibrous capsule surrounding a silicone breast implant. When one looks at the scientific literature, the incidence of what is now properly called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is highly variable. The incidents that have been reported vary from one in 355 to 1 in 30,000 patients. Because of this high variation in reported incidence, the surgeons and oncologists at Memorial Sloan Kettering Cancer Center carefully examine their experience with this disease to achieve more accurate incident estimates. Furthermore, the authors from Sloan-Kettering noted that the American Society of Plastic Surgeons noted that although the number of textured breast implants has decreased since the year 2000, more than 3 million of these devices have been used in patients in the United States, putting many women at risk of this disease.

It is important to note that virtually all these cases have been reported in patients who have had textured-surface breast implants inserted. The most common presentation of BIA-ALCL is fluid developing around the implant. This lymphoma can occur many years following the insertion of the implant. In most instances, it presents with a large spontaneous collection of fluid around the implant. On more rare occasions it can include skin rash fever and capsule contracture. The workup of this enlarged breast should begin with an ultrasound to detect fluid as well as breast masses and possibly enlarged lymph nodes. If equivocal, a breast MRI can be included in the workup. If a fluid collection is detected aspiration should be carried out and the specimen submitted for pathologic examination. Various histologic markers can be used on the specimen to help determine the diagnosis. Though no one is certain about the exact etiology of this disease some have speculated that it may possibly be due to chronic inflammation by the textured implant leading to malignant transformation of these cells.

Between 1991 and 2017 a total of 16,065 implants were placed at Sloan-Kettering. Approximately half underwent unilateral and half bilateral implant placement for breast reconstruction. Considering the surface type of implant 6149 patients had 9589 textured implants whereas 3918 patients had 6476 smooth implants. The median time of exposure to textured implants was approximately 6.5 years per implant. Patients with smooth implants had a shorter exposure time, 3.7 years per implant. Eleven cases of BIA-ALCL were diagnosed, all in patients with textured implants. The median time to diagnosis of BIA-ALCL was 10.3 years. All these cases were diagnosed in patients who were exposed to Allergan/Inamed/McGhan Biocell textured breast implants. The incidence of BIA-ALCL among those patients undergoing placement of textured implants was one in 559 patients and one in 871 implants. The authors noted that the first lymphoma cases occurred within 6 to 8 years of exposure, though most occurred at 10 to 12 years after implantation. The number of cases plateaued after 14 to 16 years after implantation of textured implants. The authors also noted that textured implants outnumbered smooth implants from 1991 to 2009. But beginning in 2009 there was a decrease in textured implant use with a concurrent increase in smooth implant utilization. The authors noted that this trend continues and that they rarely use textured implants at this time.

This appears to be the largest study examined in a “time-to-event fashion”. The incidence of BIA-ALCL noted at Sloan-Kettering is considerably higher than that reported by other studies. The authors noted that through almost 7 years of follow-up, the incidence of BIA-ALCL was nearly 0%. Following seven years, however, there was nearly an exponential rise in incidence. Though there was a loss to follow-up probably secondary to transfer of care to another institution, the results yielded an incidence of 3.31 per thousand implants at 14 to 16 years and beyond. The authors also noted that because many patients undergo bilateral breast reconstruction with textured implants the risk could conceivably be higher for BIA-ALCL development. They also noted that as recently as 2015 that annual sales of textured implants were approximately 75,000. Many of these patients are reaching the time when they are at their highest risk and thus, they stated that patient education and follow-up care are very important.

The researchers also mentioned that management options for these patients with textured implants include continued monitoring, exchange for smooth devices, or conversion to autologous tissue reconstruction. They also noted that it is unknown at this time whether the removal of the textured implant will affect the likelihood of future BIA-ALCL development going forward. The researchers also suggested that the incidence rate of BIA-ALCL may vary depending upon the surface texturing of the device which might suggest that all textured devices do not carry the same risk. All patients at Sloan-Kettering with both textured and smooth implants have been contacted regarding the risk of this type of lymphoma and were encouraged to follow up with them or their local plastic surgeon. The authors also suggested that because of the prevalence of textured implant usage, BIA-ALCL will likely increase in the coming years.

Alan Stolier

Dr. Alan Stolier, MD, FACS, clinical breast oncologist, shares his expert medical perspective with a series of educational and scientific articles.