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Other Complications

Silicone gel breast implants, such as MENTOR® MemoryGelTM Breast Implants, are one of the most studied medical devices.1-10 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.

Here we look at two complications that have been reported, but other complications can also occur.

In 2016, the World Health Organisation for the first time provisionally classified Breast Implant-Associated Anaplastic Large-Cell Lymphoma (BIA – ALCL) as a newly recognised entity and highlighted the importance of surgical management of the disease.11

Today it is believed that women with breast implants have a small, but increased risk of developing BIA-ALCL.12 More recently some women with breast implants have reported a range of systemic symptoms that they refer to as “breast implant illness” or “silicone implant illness.” To date, the overall body of scientific evidence does not support claims that breast implants cause silicone implant illness13, however further research is underway to better understand any possible connection.

Breast Implant Associated Anaplastic Large Cell- Lymphoma (BIA-ALCL)

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a rare type of T-cell lymphoma (a cancer of a type of cell of the immune system) typically occurring in a delayed fluid collection around a textured implant or surrounding scar capsule.11

Breast implants are associated with increased risk of BIA-ALCL, but the absolute risk remains small.12

BIA-ALCL patients most commonly present with a spontaneous peri-prosthetic fluid collection or capsular mass at an average of eight to ten years following implantation with a breast implant for either cosmetic or reconstructive indication.11

Many factors may contribute to the development of BIA-ALCL, including biofilm organisms, possible rare genetic predisposition and the surface texture of the implant.14

Current literature indicates that the risk of developing BIA-ALCL differs between different textured devices and has been shown to be rare with MENTOR® SILTEX® Breast Implants15,16

While MENTOR® SILTEX® Breast Implants have a low rate of BIA-ALCL16, 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.

To date there have not been any concrete or evidence-based studies or peer-reviewed data concerning the formation of a new syndrome: silicone implant illness,13 however globally there is ongoing work across industry, medical and plastic surgery societies, and researchers, 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.

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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.

References

1. Summary of the Safety and Effectiveness of Mentor’s MemoryGel® Silicone Gel‐Filled Implants in Patients who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. 10‐Year Core Gel Final Clinical Study Report. April 2013.  

2. MemoryGel® Post Approval Study Seventh Annual Report, November 5, 2013.  

3. Adjunct Study Final Report for Mentor’s MemoryGel® Silicone Gel‐Filled Breast Implants, 02 November 2012.  

4. Mentor Worldwide, LLC. MemoryShape™ Post‐Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 2015. 

5. Mentor Becker Expander/Breast Implant Clinical Trial 2013 Annual Report.  

6. Adjunct Study Annual Report for Mentor's Becker Adjustable Breast Implants: Year 18 (September 1992‐ November 2010) October 3, 2011.  

7. CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants in Subjects who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. 2015.  

8. MemoryShape™ Post‐Approval Continued Access Study (formerly Contour Profile Gel Continued Access Study). 2014. 

9. Athena Study annual report (Sept 2018): A Study of the Safety and Effectiveness of the Mentor® Smooth and Textured Larger Size MemoryGel® Ultra High Profile (UHP‐L) Breast Implants in Subjects who are Undergoing Primary Breast Reconstruction or Revision Reconstruction. 

10. Glow Study annual report (Feb 2018): Memory Gel and Shape Combined Cohort Post Approval Study. 

11. 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. 

12. De Boer, M., et al., Breast implants and the risk of anaplastic large-cell lymphoma in the breast. JAMA Oncology, 2018. 4(3): p. 335-341 

13. Rohrich, R., et al., Silicone Implant Illness: Science vs Myth. Plastic and Reconstructive Surgery: July 2019 - Volume 144 - Issue 1 - p 98-109 

14. 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.695-705. 

15. 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. 645-654. 

16. Wixtrom RN, Garadi V, Leopold J, Canady JW. Device-Specific Findings of Imprinted-Texture Breast Implants: Characteristics, Risks, and Benefits. Aesthet Surg J. 2019 

Reconstructive Surgery, 2017. 140(4): p. 645-654. 

© Johnson & Johnson Medical Ltd, 2020. 

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