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A Prospective Approach to Inform and Treat 1340 Patients at Risk for BIA-ALCL

Roberts, John M. M.D.; Carr, Logan W. M.D.; Jones, Allison B.S.N.; Schilling, Amber Pharm.D., M.Ed.; Mackay, Donald R. M.D., D.D.S.; Potochny, John D. M.D.

Plastic and Reconstructive Surgery: July 2019 - Volume 144 - Issue 1 - p 46-54
doi: 10.1097/PRS.0000000000005703
Breast: Special Topic
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Background: The increasing incidence and associated mortality of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has become alarming. However, many patients remain unaware of their risk for BIA-ALCL and may overlook early warning signs of the cancer. The authors aim to contact all breast implant patients at a single institution to educate them on the disease and provide screening and treatment as indicated.

Methods: All patients who had breast implants placed at Penn State Hershey Medical Center from 1979 to November of 2017 were mailed a letter to describe BIA-ALCL and to encourage a follow-up visit. Patient information regarding demographics, implant type, the number of calls and follow-up visits, physical examination findings, and patient decisions after being informed of the disease were recorded prospectively.

Results: One thousand two hundred eighty-four letters were mailed to 1020 patients (79.4 percent) with smooth implants and 264 patients (20.6 percent) with textured implants. Seventy-six calls were received and 100 patients (84 smooth and 16 textured) were evaluated within the first 2 months. Of the 16 patients with textured implants, nine are undergoing secondary surgery to remove or replace their textured device.

Conclusions: Informing patients at risk for BIA-ALCL is an important endeavor. Patients educated on the disease will likely be diagnosed and treated earlier, which can prevent the need for adjuvant chemotherapy and/or radiation therapy and decrease mortality. The authors provide a method, supporting documents, and preliminary data to help other institutions contact their breast implant patients at risk for BIA-ALCL.

Hershey, Pa.

From the Department of Surgery, Division of Plastic Surgery, Pennsylvania State University, College of Medicine.

Received for publication May 8, 2018; accepted November 27, 2018.

Presented at the Pennsylvania State University Hershey Medical Center Resident Research Day, in Hershey, Pennsylvania, May 19, 2018; the Robert H. Ivy Society of Plastic Surgeons Annual Meeting, in Hershey, Pennsylvania, April 27, 2017; and the American Council of Academic Plastic Surgeons Winter Retreat, in Chicago, Illinois, February 10 through 11, 2018.

Disclosure:The authors have no financial conflicts to disclose.

By reading this article, you are entitled to claim one (1) hour of Category 2 Patient Safety Credit. ASPS members can claim this credit by logging in to PlasticSurgery.org Dashboard, clicking “Submit CME,” and completing the form.

John D. Potochny, M.D., Division of Plastic Surgery, H071, Pennsylvania State University, College of Medicine, 500 University Drive, Hershey, Pa. 17033, jpotochny@pennstatehealth.psu.edu, Instagram: @johnroberts8821

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a growing concern for patients and their plastic surgeons. From the time it was first reported in 1997,1 there has been mounting evidence and increasing incidence reported to worldwide regulatory agencies. In 2011, the U.S. Food and Drug Administration first warned of a possible association between breast implants and this “rare” cancer with an incidence supposedly far less than one in 500,000.2 In the most recent March of 2018 statement, the U.S. Food and Drug Administration reported 414 adverse medical device reports of BIA-ALCL, including nine deaths.3 Worldwide, the number of total unique cases has risen to 570, including 16 disease-related deaths.4

The U.S. Food and Drug Administration states that 89 percent of patients with BIA-ALCL had textured implants.3 However, of the 11 percent with smooth implants, a history of textured implants cannot be excluded because of limitations in the way the data are recorded. The exact lifetime risk of developing BIA-ALCL is difficult to assess, as the disease has only been defined for approximately 10 years, and there is a significant lag time from implant placement to diagnosis. The best estimate from epidemiologic and implant sale reports indicate the incidence is between one in 1000 and one in 30,000 for people with textured implants.4 There are emerging data to suggest that variability exists depending on the type of texturing, and more highly textured surfaces may confer increased risk.4–6 In contrast, there is not one well-documented case of a smooth implant alone resulting in ALCL.4

Following the 2011 U.S. Food and Drug Administration public warning of a possible link between breast implants and ALCL, the Division of Plastic and Reconstructive Surgery at Penn State Hershey Medical Center has taken a proactive approach to inform patients and limit exposure to textured devices. As evidence implicating textured breast implants became better defined and the latency of symptoms was better understood, we felt it was imperative to identify our most underinformed and at-risk patients to educate them on the disease. The purpose of this study was to present a protocol for contacting breast implant patients at risk for BIA-ALCL, report outcomes on their treatment, and discuss avoidable pitfalls.

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PATIENTS AND METHODS

A timeline of events for implementation of this quality improvement project is shown in Figure 1. All Penn State Hershey Medical Center patients with breast implants placed from 1979 through 2017 were identified using CPT codes 19340, 19342, 19325, and 11970. A breast implant log book was used to capture patients before implementation of the electronic medical record. Deceased patients were excluded from review. Basic demographic and implant characteristic data including implant surface and fill type, location, and reason for placement were collected (Table 1).

Table 1.

Table 1.

Fig. 1.

Fig. 1.

Recognizing that several U.S. Food and Drug Administration medical device reports implicated smooth implants at the time of our quality improvement project (2016), we elected to contact all breast implant patients. All identified patients were categorized into either smooth or textured surface types. Textured implant catalogue numbers identified within the data set were recorded (Table 2). Patients with a history of only smooth implants received a smooth implant letter. Patients with textured implants, or who had any history of textured implant exposure (excluding textured soft-tissue expanders), received a textured implant letter.

Table 2.

Table 2.

Specific letters for each group were drafted (Fig. 2). These were crafted using an example provided by the American Society of Plastic Surgeons.7 Both letters identified BIA-ALCL as a new risk for patients with implants and contained links to high-quality resources for review. The verbiage in the textured implant letter was stronger to encourage evaluation should patients identify any concerning findings on self-examination.

Fig. 2.

Fig. 2.

Several other departments were involved to streamline patients coming to the clinic for BIA-ALCL evaluation. With assistance from information technology, a simplistic order set was created in conjunction with the pathology department. This ensured that the correct laboratory tests were sent, including cytologic analyzation for BIA-ALCL, CD30 flow cytology, and T-cell receptor gene rearrangement polymerase chain reaction if a specimen was needed for diagnosis.

The radiology department added additional time slots to expeditiously see patients who needed imaging or a tissue sample. Other specialties that interact with our breast implant patients, including family medicine, oncology, breast surgery, and obstetrics and gynecology, were educated on the disease in an effort to broaden the reach of the project.

To accommodate patients receiving the letter, a call line was created, and information regarding the number and date of calls was tracked. Additional time in the plastic surgery clinic was allocated for patients wanting to be seen. Physicians performing the evaluations were asked to fill out an assessment sheet that identified any concerning physical examination findings and whether the patient was undergoing any further diagnostic testing (e.g., ultrasound, fine-needle aspiration). Details regarding surgical procedures performed on patients after this appointment were recorded. All information obtained was then transferred to a password-protected and encrypted file on a secure server.

Before letter distribution, the information technology department and an outside vendor reviewed the list of patients to confirm addresses and identify deceased patients. The letters were distributed to all patients who received breast implants at Penn State Hershey Medical Center from 1979 to 2017.

After 2 months of data collection, a preliminary report was developed. Basic statistical assessment generated means and standard deviations for comparison to historical data. This study was approved by the institutional review board.

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RESULTS

One thousand three hundred forty patients were identified, with 1076 patients (80.3 percent) in the smooth implant group and 264 patients (19.7 percent) in the textured implant group. The average age of the patients was 56.7 ± 13.0 years and the average age of the implants was 11.8 ± 10.1 years. Nine hundred eleven patients (67.9 percent) had implants placed for reconstructive purposes, whereas 429 patients (32.0 percent) had implants placed for cosmetic purposes. Letters were sent to 1020 smooth implant patients and 264 textured implant patients. Twenty-five letters (1.9 percent) were erroneously sent to deceased individuals. Ninety-eight letters (7.6 percent) were returned without being delivered. This included 82 letters to smooth implant patients and 16 to textured implant patients. Seven patients (<1 percent) received a smooth letter but had textured implants. Patient demographics and data are summarized in Table 1.

Over 47 business days after letter distribution, phone calls were received from 76 patients, or 6.4 percent of those that received a letter (Fig. 3). This included 7.2 percent of textured implant letter recipients and 5.6 percent of smooth letter recipients. Forty-six calls (61 percent) were received in the first 2 weeks. Sixty-seven of the patients (88.1 percent) who called requested or confirmed an appointment to discuss BIA-ALCL.

Fig. 3.

Fig. 3.

Thirty-three patients were seen at their routine annual follow-up without calling the care line and were included in analysis. This resulted in 100 people being seen, including 16 patients with textured implants. Of the 16 textured implant patients, nine patients (56.2 percent) have undergone or will undergo additional surgery after being seen. Details regarding these patients are listed in Table 3. Three patients were found to have physical examination findings requiring ultrasound evaluation (two textured and one smooth). All three patients had benign findings on ultrasound and did not require any further interventions.

Table 3.

Table 3.

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DISCUSSION

The overall incidence of BIA-ALCL remains low, but has increased from less than one in 500,000 in 2008 to as high as one in 1000.2,4 Data trend toward an exclusive risk associated with textured implants,3–6,8,9 with apparent variability based on the texturing technique.4–6 Despite the relatively low risk, BIA-ALCL is an appropriate addition to surgical consents,9 and manufacturers have added the risk to their package inserts. Furthermore, two class action lawsuits have already been filed that list “negligence” and “failure to warn” as claims for client compensation.

Prospective patient counseling by means of informed consent or inclusion of BIA-ALCL risk on manufacturer’s product brochures does not address patients who have undergone surgery previously. Neither the U.S. Food and Drug Administration nor the American Society of Plastic Surgeons has directly addressed this issue. Given the high cure rates in early-stage disease, we believe it is important to inform former patients who are most at risk of the disease given its delayed presentation. This may result in quicker diagnosis and prevent morbidity or mortality. A checklist for other institutions hoping to complete a similar project is provided (Fig. 4).

Fig. 4.

Fig. 4.

Our methods for contacting patients focused on sending certified letters, and then providing a call line, office visits, and additional procedures as indicated based on physical findings or patient desire. One of the greatest hurdles to overcome through this 18-month quality improvement project was approval from risk management. This time-consuming process was in part attributable to the novelty of the disease and potential legal ramifications with patient notification. We believe that it is imperative for other institutions considering a similar project to involve risk management early.

The letters were drafted with great care to both properly educate patients and possibly prevent unnecessary concern. Smooth letters emphasize that the U.S. Food and Drug Administration data suggest a significantly lower risk (Fig. 2, above). Given the higher associated risk with textured implants, stronger language was used (Fig. 2, below). Both letters contain high-quality resources for patients to review and a telephone number to reach our clinic and schedule an appointment.

The call line was created so a nurse educated on BIA-ALCL could answer patient questions and facilitate scheduling appointments. We anticipated approximately 35 percent of people receiving the letter to call our offices. However, only 6.4 percent of people receiving a letter contacted us. Our experience may underrepresent the number of calls other practices implementing this protocol would receive, for several reasons. Our implant patients are asked to follow up on an annual basis for the lifetime of the device, which may not be the practice standard for other plastic surgeons. Patients are routinely educated about BIA-ALCL at these visits, so many patients were already aware of the cancer before receiving letters. Finally, practices with a greater proportion of implants placed for reconstructive reasons or those using more textured implants may find their call and clinic visit volumes are much higher.

With regard to clinic visits, breast reconstruction and augmentation is currently performed by five surgeons within our division. Each attending surgeon and one certified registered nurse practitioner staffed an additional half day of clinic per month to accommodate patients expeditiously. One hundred patients (7.8 percent) that received the letter have been seen over 2 months. In the three cases where additional evaluation was indicated, patients were seen by the radiology department and had ultrasound examinations performed on the same day. We believe that coordinated care is a critical part of the protocol, as we had significant difficulties obtaining test results for one of the patients previously diagnosed at our institution.

We attempted to make clinic visits free for patients but found that for a variety of reasons this was not possible. When the visit was not covered by insurance or when patients did not have insurance, financial services personnel worked with patients to drive down costs as low as possible. Surgeon’s fees were also waived to decrease operating room costs when applicable.

Prophylactic breast implant removal in patients without symptoms or other abnormalities is not recommended. Patients are advised during their visit that the risk of morbidity with additional surgery is higher than the risk of developing BIA-ALCL. Patients are also counseled that exchanging textured for smooth implants may not eliminate their risk of developing BIA-ALCL. These points are stressed with all patients. However, over half of patients (56.2 percent) with textured implants who sought follow-up to our letters have elected to undergo further surgery, with 77.7 percent electing to have exchanges to a smooth implant and 23.3 percent undergoing explantation without replacement. Many of the women in the data set have already been diagnosed with breast cancer, and the idea of facing a new cancer may be worrisome enough to accept the risks of surgery. In addition, if the patient is already going to require revision surgery for some other cause, exchange for a smooth implant or explantation can be performed at that time.

We elected to discontinue the use of textured implants given the growing association with BIA-ALCL. This is backed by American Society of Plastic Surgeons recommendations suggesting that surgeons use smooth implants when results would be otherwise equivalent.4 Perhaps the most compelling reasons to continue using textured implants are an association with lower rates of capsular contracture10–12 and “shaped” options, with good patient- and physician-reported outcomes.13,14 However, our experience has not indicated that these purported benefits are worth the potential risks. We believe comparable results can be obtained with smooth implants. We also discontinued the use of textured tissue expanders during the course of this project, with the understanding that there is no evidence to suggest a correlation between textured expander use and BIA-ALCL.

Over the 2 months since letters were distributed, we have learned several lessons and potential pitfalls. Retrospective evaluation taught us that direct communication with the letter distributor is vitally important. Despite checks and rechecks by internal and external vendors, one known living patient was not sent a letter, and several known individuals who had died were erroneously sent letters. Ninety-eight letters have been returned, and seven patients with textured implants were sent letters for smooth implant recipients. After further review of these issues, it is believed that the outside vendor did not fully recognize the delineation of patient lists provided to them.

The cost-to-benefit ratio of this project is subject to criticism. The time and money commitment needed to implement this patient outreach program may be difficult to rationalize when the highest incidence estimation is 0.1 percent. However, when diagnosed at an early stage, BIA-ALCL is highly curable. Patients educated on the signs and symptoms are more likely to identify a concerning change to their implant and seek treatment sooner.

Institutions and physician practices will have to individually determine whether or not an analogous project is necessary for their breast implant patients. Further consideration on the need to involve smooth implant patients and delineating patients based on the type of texturing is warranted. Practices placing more textured implants and those without formal long-term follow-up may be more inclined to educate their prior patients.

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CONCLUSIONS

The current doctor-patient relationship and medicolegal environment demand a comprehensive review of the risks of surgery. Physicians and breast implant manufacturers must adjust their practices as new information on BIA-ALCL becomes available to properly educate patients and avoid morbidity and mortality. The current study proposes one method for contacting breast implant patients at risk for BIA-ALCL and may help other programs with regard to expectations and resource allocation.

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ACKNOWLEDGMENT

The authors thank Pat Drobnick for clinical support.

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REFERENCES

1. Keech JA Jr, Creech BJ. Anaplastic T-cell lymphoma in proximity to a saline-filled breast implant. Plast Reconstr Surg. 1997;100:554–555.
2. U.S. Food and Drug Administration. Anaplastic large cell lymphoma (ALCL) in women with breast implants: Preliminary FDA findings and analysis. Available at: http://wayback.archive-it.org/7993/20171115053750/https:/www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm. Accessed April 5, 2018.
3. U.S. Food and Drug Administration. Breast implants: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm. Accessed January 10, 2018.
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