This information is from the American Society for Aesthetic Plastic Surgery.
Q: What is BIA-ALCL?
A: BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma) is a rare spectrum of disease that can range from an indolent accumulation of fluids around the breast (seroma) to a potentially metastatic lymphoma especially when there are delays in diagnosis. It is a disease that ranges from indolent to full-blown metastatic disease when not caught early. BIA-ALCL is not a cancer of the breast tissue itself. When diagnosed early, it is readily curable. If the disease is advanced, chemotherapy or radiation may be required.
Q: Have there been any deaths due to BIA-ALCL?
A: There have been 17 confirmed deaths globally, (9 in the United States), attributed to BIA-ALCL since the disease was first reported nearly 20 years ago.
Q: What are the symptoms of BIA-ALCL?
A: The first symptom of BIA-ALCL is usually a swelling of the breast between 2 to 28 years after the insertion of breast implants, with an average of about 8 years after implantation. The swelling is due to a collection of fluid surrounding the implant. This fluid can cause the breast to enlarge significantly over a period of days or weeks. It can also present as a lump in the breast or armpit, firmness of the breast, or pain. It is usually easily and completely treated if patients see their doctor at the first symptom.
Q: What is the risk of developing BIA-ALCL?
A: The FDA reports that it is 1:3,817 to 1:30,000 in its latest statement. These risk assessments are changing on an ongoing basis, but this is the most accurate information currently available.
Based on current data, the risk can be further explained by the texture grade of the implants as follows:
• Grade 1 (Smooth only) – The current lifetime risk is 0.
• Grade 2 (e.g. Microtexture, Siltex and similar) – 1:82,000
• Grade 3 (e.g. Macrotexture, Biocell and similar) – 1:3,200
• Grade 4 (e.g. Polyurethane) – 1:2,800
Q: If a breast implant patient sees a plastic surgeon when she develops a first symptom, will she be cured?
A: That answer is not known and is a very important piece of information for patients and plastic surgeons. Most of the time patients see their plastic surgeon right away when they develop significant swelling of the breast. In these cases, the disease is almost always caught early and cured with a straightforward operation. Some women with advanced disease ignored earlier symptoms or saw a doctor who did not properly diagnose them. There are a few patients who presented with advanced disease who said that they never had earlier symptoms.
Q: Can you explain the differences in implant texture and what role that factor plays in the research?
A: Although it is rare, BIA-ALCL appears to currently develop exclusively in women with textured implants. To date there has not been a case of BIA-ALCL in a patient with only smooth implants. There are several theories which attempt to explain the higher rate for textured implant patients: many believe that the increased surface area of textured implants allows a higher number of bacteria around the implant, which forms a biofilm in some patients, and can result in chronic inflammation, ultimately leading to a proliferation of lymphocytes. Less accepted theories are that textured implants create greater inflammation because of chronic mechanical irritation, and another postulates that microscopic shedding of silicone from the textured wall induces inflammation.
Q: Is it a problem with Saline or Silicone implants?
A: Of the 457 unique cases of BIA-ALCL (FDA 2-2019) implants are both silicone and saline. It appears to purely be related to the surface of the implant and not to what the implant is filled with.
Q: How does this impact those with breast implants?
A: The most important issue for women with breast implants is to screen for breast cancer with self-exam, a regular physician exam, and mammography/ultrasound/MRI as recommended by their physician. Regardless of BIA-ALCL, all women should see their plastic surgeon immediately if they note a change to the size, feel, or shape of their breasts.
Q: What about those considering breast implants?
A: Patients considering textured breast implants should discuss this issue with their plastic surgeon. Since knowledge of this condition is continuing to evolve, patients should check the FDA website for any updates. Currently the FDA has asked Allergan to voluntarily recall certain textured implants.
Q: Why would my surgeon have recommended textured implants for me?
A: The choice of implant type is ultimately a decision between an educated patient and her board certified plastic surgeon. There are two primary reasons the surgeon may have recommended textured surface breast implants. First is that some data has shown a lower rate of capsular contracture (firm scar tissue formation around the implant). Second, all teardrop or anatomic shaped implants have a textured surface to help hold them in place. Some surgeons believe these implants can offer an enhanced shape for certain patients, perhaps with a reduced risk of rippling.
Q: How is BIA-ALCL diagnosed?
A: If a woman develops swelling in an augmented breast, she should undergo an ultrasound scan. If fluid is detected, it should be drained and tested for:
CD30 immunohistochemistry is not diagnostic for BIA-ALCL; however, it is a marker for activated T-Cells. If a patient’s seroma is CD30 positive, and the cytology is negative, this likely represents a precursor to BIA-ALCL, and should be treated with total capsulectomy. If the seroma test is CD30 negative with negative cytology, then it should be treated as a benign seroma using the individual surgeon’s protocol.
The majority of seromas seen clinically are benign seromas and not BIA-ALCL. Management of all seromas should be by a board-certified plastic surgeon. Mammograms are not useful in diagnosing BIA-ALCL. In confirmed cases PET or MRI/CT scans may be used to help stage the disease.
If a patient wants to have their textured implants removed and replaced, the options are:
• Exchange to smooth implants
• Exchange to smooth implants with a capsulectomy
Q. How is BIA-ALCL treated and what is the prognosis?
A. Current recommendations for the treatment of BIA-ALCL call for bilateral capsulectomy (removing all the scar tissue) and removal of the old breast implants. This is a very common procedure performed by plastic surgeons, identical to what is done when an implant has ruptured or capsular contracture has developed. Smooth implants can be put back in or the patient can choose not to have implants. In all early stage cases, the disease has been fully resolved by this surgery alone. The majority of patients require no additional treatment. However, if the disease has spread to lymph nodes or grown into the adjacent tissues, chemotherapy and radiation may be necessary. This has only been necessary in a small percentage of patients.
Q: Are some patients at greater risk than others?
A: The rates of BIA-ALCL seem to have different rates throughout the world. This may be due to different reporting and registries, but there is likely to be a genetic predisposition that is not yet fully understood. For instance, as of this time there are very few cases in Asian patients. The risk is only with textured implants and not smooth implants; the rate is no different between silicone and saline; it occurs in both cosmetic and reconstructive patients. There is no test to determine whether one textured implant patient is at any more risk of developing this disorder than any other patients.
Q: Should patients have their implants removed because of BIA-ALCL?
A: For textured implant patients, neither the FDA nor any plastic surgery society currently recommends that women should preventatively remove textured breast implants to prevent BIA-ALCL. However, there are women who have been concerned enough about BIA-ALCL and have chosen to have their implants removed. There are some women who were already considering a breast implant revision, and the BIA-ALCL issue gave them one more reason to decide to proceed.
Breast implant patients should have ongoing follow up. Current FDA recommendations indicate that patients with textured implants with no issues should not do anything and implant removal is not recommended. With the voluntary recall of selected Allergan Biocell implants, Allergan will replace the Biocell textured implants with smooth round implants for free until July 24, 2021. However, Allergan does not pay the surgery fees, such as operating room, anesthesia, surgeon fees, etc. associated with the implant replacement. The surgery fee is a patient responsibility when there is no indication of BIA-ALCL.
In August 2019 Allergan sent letters to patients of the recalled products. Allergan’s records are limited to the patients providing a valid address as part of device tracking. Patients who had elected to ‘opt-out’ of device tracking as well as those with textured saline breast implants and tissue expanders have access to the same information through the Allergan website. For more information please contact Allergan Medical Information at 1-800-678-1605, option #2 or email IR-Medcom@allergan.com.
Q: Should women with breast implants be screened for BIA-ALCL?
A: There is no blood test to specifically screen for BIA-ALCL. The expert opinion is that asymptomatic women without breast changes do not require more than routine mammograms and breast exams. But if a patient experiences a change in her breasts – especially if there is swelling or a lump – she should undergo immediate examination, imaging, and consultation with a plastic surgeon. If there is fluid around the implant the fluid should be aspirated under ultrasound guidance and sent for analysis.
Q: What causes BIA-ALCL?
A: ASAPS, ASERF, the FDA, and the implant manufacturers are intensely studying BIA-ALCL. To date, no specific causal factors have been identified. Implant texturing, bacteriologic contamination, and genetic factors have been implicated and are undergoing further study. The best theory today is that a combination of four factors are required for the development of BIA-ALCL:
1. Textured implants (surface area to sequester bacteria)
2. Chronic bacterial-inflammation
3. Genetic predisposition
The source of the chronic inflammation is thought to be bacteria that have been identified around the implants in affected breasts. Evidence is accumulating that a long-term inflammatory response to the presence of these bacteria is one of the factors that may cause BIA-ALCL. Research is ongoing and cases are being monitored.
Genetic factors may play a role. Some geographic areas have reported very few cases. Ongoing data collection worldwide will help to determine whether or not there are any genetic propensities for this disease.
Q: Is there any assistance available to the patient?
A: The Mollenkopf Aesthetic Breast Reconstruction Fund and the BIA-ALCL Patient Assistance Fund can offer financial assistance to patients. Additionally, Sientra offers to cover lab testing for any seromas associated with their implants.
The Mollenkopf Aesthetic Breast Reconstruction Fund offers funding for breast reconstruction patients. The Mollenkopf Aesthetic Breast Reconstruction Fund provides grants to ASERF/ASAPS member surgeons, to financially assist patients in completing their aesthetic breast reconstruction journeys. These funds are intended to help underinsured or uninsured patients nationwide cover the associated costs with breast reconstruction. The goal of this fund is to provide women with limited financial means the opportunity to achieve the best possible aesthetic breast reconstruction result. In particular, the grant is focused on women who need a final surgery or revisional surgery to complete their aesthetic reconstruction. The goal is for ASERF/ASAPS members to help women feel good about themselves after their reconstruction and aid them in returning “back to me.”
The BIA-ALCL Patient Assistance Fund. The American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS), in conjunction with the Aesthetic Surgery Education and Research Foundation (ASERF) and the Plastic Surgery Foundation (PSF), offer funding for patients diagnosed with breast implant associated anaplastic large cell lymphoma (BIA-ALCL). These funds are intended to help underinsured or uninsured patients who are seeking surgical treatment of BIA-ALCL, total capsulectomy and explantation, and excision of associated mass with biopsy of suspicious node(s) and implant-based reconstruction, if indicated. The goal of this Fund is for ASAPS, ASPS, ASERF, and PSF members to help patients obtain treatment when insurance limitations would have otherwise restricted their ability to do so. The Fund is made possible by generous contributions from Allergan, Mentor Worldwide, LLC and Sientra, Inc.
In response to Allergan’s voluntary recall of Biocell® textured implants, Allergan issued a Biocell Replacement Warranty, which provides for replacement of the affected implants with Allergan smooth implants.
The Sientra Platinum20™ Product Replacement and Limited Warranty Program for Sientra Opus™ Silicone Gel Breast Implants (Smooth and Textured Surface) offers assistance with patients presenting with late-forming seromas.
Mentor has issued a BIA-ALCL policy that will provide the affected patient with up to $7,500 in financial assistance to go toward the patient’s out of pocket BIA-ALCL costs for diagnosis and medical treatment.
Contact Fox Valley Plastic Surgery at (920) 233-1540 or request your consultation online. The decision to remove or replace implants is not always clear cut. We have helped patients from Green Bay, Sheboygan, Appleton, Neenah, Oshkosh, Fond du Lac, and West Bend determine the best course of action regarding Breast Implant-Associated Anaplastic Large Cell Lymphoma. Our board certified Wisconsin plastic surgeons are helping women from all over the upper Midwest to perfect their personal Renaissance. Request your consultation today.