Rare Complications
Breast implants are widely considered among the most intensely studied and regulated devices in the medical industry. For nearly four decades, MENTOR®, along with US FDA and other regulatory bodies, have closely tracked and monitored patient satisfaction and complications associated with breast implants through clinical studies, registries, and real-world complaint data to better understand the breast implant benefits and safety.
In 2011, US FDA identified an association between breast implants and the development of anaplastic large cell lymphoma (ALCL). Today it is believed that women with breast implants have a very small, but increased risk of developing Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL). More recently some women with breast implants have reported a range of systemic symptoms that they refer to as “breast implant illness.” To date, the overall body of scientific evidence does not support claims that breast implants cause systemic illness, however further research is underway to better understand any possible connection.
Breast Implant Associated Anaplastic Large Cell- Lymphoma (BIA-ALCL)
Women with breast implants are at a small but increased risk of developing Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA- ALCL), a type of non-Hodgkin’s lymphoma that is highly curable if detected early.1,2 BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma (cancer of the immune system), that affects lymphocytes (immune cells), typically taking between 8-10 years to develop.3 In most cases (>85%), BIA-ALCL is found in the implant effusion (fluid surrounding the implant), which current data suggest may be cured by removal of the implant and capsule.4
Many factors may contribute to the development of BIA-ALCL, including bacterial contamination, genetic predisposition and the surface texture of the implant. Current literature, and real world evidence, concludes that the risk of developing BIA-ALCL differs between different textured devices and has been shown to be rare with MENTOR® Breast Implants. 5-11
While MENTOR® Breast Implants have a low rate of BIA-ALCL, it remains a concern we take seriously. We closely monitor the clinical performance of our breast implants through clinical studies, registries and post market surveillance activities and continue to work with industry groups, physicians, scientists and health authorities to better understand the associated risks and causes of this type of lymphoma.
Breast Implant Illness
Some patients with breast implants have reported a range of systemic symptoms which they refer to as breast implant illness. Some reported symptoms include fatigue, chronic pain, rash, anxiety, muscle pain, recurring infections and swollen lymph nodes. While the current body of scientific evidence does not support claims that breast implants cause systemic illness, FDA, in partnership with industry, medical and plastic surgery societies, and researchers is taking steps to better characterize the set of conditions and its risk factors and researchers are working to understand the origins of the symptoms.
We support these efforts and have been partnering with the regulatory authorities around the world and diligently reviewing our long-term implant safety and real-word complaint data seeking to better understand any possible connection.
Talk to Your Doctor
Following your breast surgery, it’s important that you have regular follow up exams and follow your doctor’s instructions to monitor your breast implants. If you notice any changes to your breast implants or experience any unusual signs or symptoms of health issues, contact your health care provider promptly to schedule an appointment.
It is important for you to have a discussion about these risks with your doctor and/or surgeon so that you have a full understanding of both benefits and risks before undergoing surgery for breast implants.
1.Clemens MW, Medeiros LJ, Butler CE, Hunt KK, Fanale MA, Horwitz S, et al. Complete Surgical Excision Is Essential for the Management of Patients With Breast Implant-Associated Anaplastic Large-Cell Lymphoma. J Clin Oncol. 2016;34(2):160-8. Epub 2015/12/03.doi: 10.1200/jco.2015.63.3412. PubMed PMID: 26628470; PubMed Central PMCID: PMCPMC4872006 online at http://www.jco.org. Author contributions are found at the end of this article.
2. Clemens MW, Horwitz SM. NCCN Consensus Guidelines for the Diagnosis and Management of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Aesthetic surgery journal. 2017. Epub 2017/02/12. doi: 10.1093/asj/sjw259. PubMed PMID: 28184418.
3.Clemens, M.W., et al., How to Diagnose and Treat Breast Implant–Associated Anaplastic Large Cell Lymphoma. Plastic and Reconstructive Surgery, 2018. 141(4): p.587e.
4. Deva, A.K. Breast Implant Associated Large Cell Lymphoma (BIA-ALCL) – Key Update. Plastic Surgery Hub. https://www.plasticsurgeryhub.com.au/breast-implantassociated-anaplastic-large-cell-lymphoma-bia-alcl-key-update/. June 8, 2018, accessed Aug 7, 2018.
5. Brody, G.S., et al., Anaplastic Large Cell Lymphoma Occurring in Women with Breast Implants: Analysis of 173 Cases. Plastic and Reconstructive Surgery, 2015. 135(3): p.17.
6. Gidengil, C.A., et al., Breast Implant–Associated Anaplastic Large Cell Lymphoma: A Systematic Review. Plastic and Reconstructive Surgery, 2015. 135(3): p. 715, 719.
7. Loch-Wilkinson, A., et al., Breast implant associated Anaplastic Large Cell Lymphoma in Australia and New Zealand - high surface area textured implants are associated with increased risk. Plastic and Reconstructive Surgery, 2017. 140(4): p. 2.
8. Doren, E.L., et al., U.S. Epidemiology of Breast Implant–Associated Anaplastic Large Cell Lymphoma. Plastic and Reconstructive Surgery, 2017. 139(5): p. 2.
9. Srinivasa, D.R., et al., Global Adverse Event Reports of Breast Implant-Associated ALCL: An International Review of 40 Government Authority Databases. Plast Reconstr Surg, 2017. 139(5): p. 1039.
10. Johnson, L., et al., Breast implant associated anaplastic large cell lymphoma: The UK experience. Recommendations on its management and implications for informed consent. Eur J Surg Oncol, 2017. 43(8): p. 1395.
11. Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses: Center for Devices and Radiological Health, U.S. Food and Drug Administration; January 2011 [cited 2021 28 June].
Important Safety Information:
The MENTOR® Collection of Breast Implants are indicated for breast reconstruction and breast augmentation - in women who are at least 18 years old for MENTOR® MemoryGel® Breast Implants, MENTOR® CPGTM Breast Implants, or MENTOR® Saline Breast Implants.
Breast implant surgery should not be performed in women:
- With active infection anywhere in their body
- With existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions
- Who are currently pregnant or nursing
Safety and effectiveness have not been established in patients with autoimmune diseases (for example lupus and scleroderma), a weakened immune system, conditions that interfere with wound healing and blood clotting, or reduced blood supply to breast tissue. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery.
There are risks associated with breast implant surgery. You should be aware that breast implants are not lifetime devices and breast implantation may not be a one-time surgery. The chance of developing complications increases over time. You may need additional unplanned surgeries on your breasts because of complications or unacceptable cosmetic outcomes. Many of the changes to your breast following implantation are irreversible (cannot be undone) and breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production.
Breast implants are not lifetime devices and breast implantation may not be a one-time surgery. The most common complications for breast augmentation with MemoryGel® Implants include any reoperation, capsular contracture, nipple sensation changes, and implant removal with or without replacement. The most common complications with CPGTM Breast Implants for breast augmentation include reoperation for any reason, implant removal with or without replacement, and ptosis. A lower risk of complication is rupture. The health consequences of a ruptured silicone gel breast implant have not been fully established. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture. Breast implants are also associated with the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), an uncommon type of lymphoma. An individual's risk of developing BIA-ALCL with MENTOR® Breast Implants is low based on the data currently available on the incidence of worldwide cases.
Detailed information regarding the risks and benefits associated with MENTOR® Breast Implants is provided in several educational brochures, including the ‘Important Information for Woman Considering Breast Implants’ brochure, and the ‘Making an Informed Decision’ brochure. These brochures are available from your surgeon or visit https://breastimplantsbymentor.net/safety/mentor-safety. It is important that you read and understand these brochures when considering MENTOR® Breast Implants.
MENTOR® CONTOUR PROFILETM Breast Tissue Expanders are used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. These expanders are intended for temporary subcutaneous or submuscular implantation; they should be used within a time frame determined by the physician to achieve the clinically desired degree of tissue expansion.
DO NOT use the MENTOR® CONTOUR PROFILETM Tissue Expander in patients that have a previously implanted device such as pacemakers, drug infusion devices, artificial sensing devices, etc. that could be affected by a magnetic field. Mentor has not tested the effects of radiation therapy with the MENTOR® CONTOUR PROFILETM Expander devices. The incidence of extrusion of the expander has been shown to increase when the expander has been placed in injured areas: scarred, heavily irradiated or burned tissue, crushed bone areas, where severe surgical reduction of the area has previously been performed; and where steroids are used in the surgical pocket. Detailed information about indications, contraindications, warnings, and precautions associated with the use of MENTOR® CONTOUR PROFILETM Expanders are provided in the Instructions for Use (IFU) available online at www.mentorwwllc.eu
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