How to Follow the Cancer Risk of Women with Breast Implants

The risk of inflammatory changes, potential autoimmune
diseases and breast cancer in women with breast implants are now
well recognized..


Introduction
The risk of inflammatory changes, potential autoimmune diseases and breast cancer in women with breast implants are now well recognized [1][2][3][4][5][6]. Given the prevalence of breast implants and the likelihood that they will not become a thing of the past, it is important that clinicians be able to monitor the overall health of the women and men with breast implants by measuring changes in breast health [7][8][9]. This study investigated the prevalence of inflammatory changes in women with breast implants and monitored those changes by measuring metabolic and Regional Blood Flow (RBF) differences associated with inflammatory and cancerous breast changes using The Fleming Method for Tissue and Vascular Differentiation and Metabolism molecular breast imaging.

Patient Enrollment
Eighteen breast implants were interrogated in women with breast irregularities. The women volunteered to undergo FMTVDM Molecular Breast Imaging (MBI), to measure changes in breast tissue RBF and metabolism, to determine if there was evidence of inflammation, precancerous changes or cancer. Their mammography findings were compared along with the information already known about the extent of their breast health. All components of FMTVDM are already FDA approved -including the enhancement of Regional Blood Flow (RBF) and metabolic differences, isotopes and camera. Each woman signed an informed consent agreeing to participate in the nuclear imaging protocol. All personal identifying information was redacted to protect patient identification.

Breast Imaging
Prior to imaging, the nuclear technologist calibrated the Siemens Orbiter camera according to patent instructions to guarantee quantitative calibration of the camera in addition to customary qualitative controls. Patients arrived in the overnight fasting state and were prepared for imaging with placement of an intravenous catheter through which a vasodilator (enhancement) was given, followed by the imaging isotope and flush as previously described [7][8][9].

Patient Records
Patients provided inter alia detailed medical records, including prior biopsy results, mammography results, family history of cancer, any prior False Positive or False Negative (FPFN) results from prior testing including but not limited to mammography, smoking history, current medications, any diagnosis of dense breasts and breast implants.

Measurement of RBF and Metabolic Differences -Maximal Count Activity (MCA)
Following image acquisition, Regions of Interest (ROI) were drawn around the acquired breast images and the measured scintillation activity of RBF and metabolic differences was obtained (MCA).

Results
The diagnostic information obtained from these 18 breast implants and patient medical records/information are shown in Table 1, including specific details for each Region of Interest (ROI) measured, along with the patient number and breast involved. The measured MCA for each ROI is shown, along with tissue information, the presence or absence of breast implants, dense breasts and FP mammography results. The MCAs were compared with the previously published [7,8] values for breast tissue including women without inflammation or cancer (MCA 144 + 30; 95% CI 138-150), women with inflammation (MCA 229 + 50; 95% CI 219-240) and women with breast cancer (MCA 446 + 80; 95% CI 404-489). Later research [7,9]

Discussion
While the sample size was relatively small, it provided adequate information to demonstrate that changes in breast tissue inflammation, precancerous and cancerous changes are measurable in women with breast implants. In this study, onethird of the implants were associated with precancerous or cancer changes in the breast and twenty two (22%) percent were associated with inflammation. There was one instance of breast cancer. While the purpose of this study was not to conclude that the breast implants were the cause of the changes in breast tissue, it demonstrated the ability to measure the tissue changes occurring behind the breast implants. Women will undoubtedly continue to have breast implants for a variety of reasons. Perhaps the most clinically important are women who have undergone reconstructive surgery post mastectomy for the treatment of breast cancer. In these women there is a particular risk for recurrence of cancer, which becomes more difficult to evaluate in the presence of breast implants presenting a special challenge for clinicians [10,11]. Breast implants do not affect MCA measurement as the isotope is not taken up into the implants, allowing clear measurements to be obtained in the presence of breast implants [7]. Thus, allowing these women, and men, to be safely monitored for evidence of tissue change in the face of breast implants.

Conclusion
Using FMTVDM, women and men with breast implants can be monitored for changes in breast tissue including inflammation, precancerous and cancer change-alerting clinicians to possible concerns and the need for implant extraction [2] or other treatment The Fleming Method for Tissue and Vascular Differentiation and Metabolism.