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Breast Implant Illness

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Breast Implant Illness

The Aesthetic Society: BIA-ALCL Task Force Q1 2020 Update
BIA-ALCL Presenting as Late Capsular Contracture without Seroma

Dear Colleagues:

This will be the first installment of a quarterly update from The Aesthetic Society’s BIA-ALCL Task Force.

We plan on covering a topic of interest regarding the current etiology and treatment of BIA-ALCL.

Photo1 9900000000028a3c 295x300 webp

We will also provide the most recent US and worldwide incidence statistics.

Our first update focuses on the presentation of BIA-ALCL not as a late seroma, but as delayed capsular contracture. As our understanding of the presentation of this entity has developed, the most common presenting finding was shown to be a late seroma, particularly in a patient with a textured surface implant an average of 8-10 years following implantation. 8-24% of cases also presented with a palpable mass and 4-12% with lymphadenopathy. In less than 5% of cases the presentation included skin rash, fever and capsular contracture.(1)

Recently, Dr. Melinda Haws and I encountered patients in whom the presenting finding was a late capsular contracture without any evidence of a seroma.

A brief description of each case can be found below:

Case 1 (Bruce W. Van Natta, MD )

A 44-year-old patient presented 11 years following bilateral breast augmentation with Allergan style 410 devices. Developed a left capsular contracture within a year of presentation which had progressed to grade 4. No evidence of swelling. Office ultrasound was negative for rupture or fluid. Surgical plan was for removal and replace to smooth gel implants with total capsulectomy on the contracted left side.

At the time of surgery during a complete capsulectomy, three large nodules were encountered on the anterior surface on the left and were sent to pathology for analysis and to rule out BIA-ALCL (see photo
below).

No appreciable fluid was encountered on either side. A complete capsulectomy was performed on the non-contracted side as well. Histopathology revealed ALCL, CD 30+, ALK -. An initial PET scan was positive in the area of the pectoralis muscles on each side believed to be compatible with post-surgical change. A subsequent PET scan performed 3 months later was negative. The patient remains asymptomatic at 5 months.

Case 2 (Melinda J. Haws, MD)

A 34-year-old underwent primary augmentation with Biocell devices 9 ½ years ago. She
developed an initial left capsular contracture 7 ½ years post augmentation. She declined capsulectomy and implant exchange at that time. Subsequent to receiving a recall letter she returned with no change in the grade 3 contracture. Office ultrasound showed no fluid or evidence of rupture bilaterally.

2 months later the patient returned with minimal swelling and a small amount of fluid on the left side, found on repeat ultrasound. Planned surgery was total capsulectomies, site change to subpectoral with new round smooth implants. A thick, yellow orange fluid—approximately 40cc’s was encountered at surgery and sent along with the capsules to pathology. Flow cytometry of the fluid was negative. Pathology revealed 2.8 x2.3 x 0.8cm mass with “extension through the fibrous capsule into the surrounding adipose tissue.”

Also noted, were “large dysplastic cells strongly and uniformly CD30 positive” and ALK negative. PET/CT skull base to thighs showed symmetric hyperactivity in the tonsils and mild hypermetabolic activity adjacent to the medial aspect of the left implant read as: “could be post-surgical.” A PET scan was felt to be nonspecific and non-concerning by oncology. Follow up PET scan was scheduled for 3 months later.

The Takeaway: While about 80% of new BIA-ALCL patients may present with the classic late seroma, the lack of a seroma does not rule out the disease.

Ideally, PET scans should be obtained preoperatively on patients presenting with a late developing capsular contracture and the patient should be informed of the possibility of the ALCL diagnosis.

Additionally, if surface nodules are encountered unexpectedly at the time of capsulectomy, every endeavor should be made to surgically obtain clear margins. This may include taking additional breast and adipose tissue around the anterior capsule and nodules.

Current Incidence of BIA-ALCL as of February 2020 (Source: PROFILE American Society of Plastic Surgeons –
https://www.thepsf.org/research/registries/profile)

United States Cases: 307 Worldwide Cases: 885

US Deaths: 13 Worldwide Deaths: 25

Thank you,

Bradley Calobrace, MD
Chair, The Aesthetic Society BIA-ALCL Task Force

Bruce W. Van Natta, MD
Vice-Chair, The Aesthetic Society BIA-ALCL Task Force

1) Clemens MW, Jacobsen ED, Horwitz SM. 2019 NCCN Consensus Guidelines on the Diagnosis and Treatment of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Aesthetic Surgery Journal 2019; 39(S1): S1-13.

Breaking News:

Dr. Barr announced today, Thursday June 27th 2019 – “Due to ongoing FDA and Clinical Investigation along with heightened patient concerns and reports regarding breast implants, I have chosen NOT to perform Breast Implants.”

Known Illness Association with Breast Implants in Palm Beach, FL

Although the association between breast implants and hormonal, thyroid, or other autoimmune type illnesses has yet to be definitively and scientifically established by the medical community, we are listening to our patients and reported symptoms and documented illness.

Potential risks of breast implants are typically those that are commonly associated with undergoing any surgery, such as scarring, pain and infection. According to the FDA, the major risks of breast implants are capsular contracture and a form of cancer called anaplastic large cell lymphoma (BIA-ALCL). Regardless of the lack of research women reporting sicknesses need to be listened to and provided solutions.

Breast Implant Illness Symptoms and Concerns
If you have breast implants and you are experiencing any of the following unexplained symptoms or illnesses:

  • Brain Fog
  • Unexplained fatigue
  • Thyroid problem
  • Rheumatoid arthritis
  • Autoimmune Illness
  • Hair loss
  • Skin allergies
  • Muscle weakness or joint pain

We recommend a Complimentary consultation with Dr. Barr. Call today, (561) 833-4122.

Every woman’s experience with breast implants is unique to them and the best way to gain knowledge and ask personal questions would be to schedule a complimentary consultation with Dr. Barr.

Help Us Help You, Fill Out The Form On This Page

Watch This Video: Terri Diaz and Jennifer Robb are working for you! They tell their story here and their trip to Washington, D.C. to push for changes regarding breast implants. Dr. Barr discusses what he is seeing and what he wants women to know.

Like Amy, many women are reporting autoimmune disorders, hormonal imbalances and gastrointestinal problems which they attribute to their breast implants.

View Amy’s Story here: Breast Implant Explantation | Fox News Amy & Dr Barr

According to the U.S. Food and Drug Administration (FDA), “Breast Implant Illness” (BII) is the term patients may use to describe their symptoms. Reported symptoms may include, but are not limited to, fatigue, low energy, brain fog, memory loss, headaches, joint and muscle pain, hair loss, repeated infections, swollen lymph nodes and glands, rashes, gastrointestinal upset, weight loss, insomnia, anxiety and depression.

Some women who are not sick are electing to remove their breast implants for precautionary measures. Other women are electing to remove their implants when it is suspected their implants be making them sick.

FDA Statement Regarding Breast Implants

Read the latest statement from The American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons have been working collaboratively to keep plastic surgeons informed of the latest information on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

The Choice Is Yours – Remove Breast Implants

Regardless of future definitive scientific information, it is abundantly clear women state their bodies are being adversely affected by their implants and deserve to have their concerns acknowledged. For our patients, renowned West Palm Beach plastic surgeon Dr. Fredric Barr has advocated for the removal of their implants and surrounding scar tissue (Total En Bloc Removal) whenever medically possible in hopes of freeing these women from the adverse reactions their bodies are suffering. Dr Barr’s patient, Cindy, had her implants removed and experienced amazing results in a short period of time. Watch Video Below For Her Story.

Dr. Barr endeavors to empower women through education and support so they can make an informed decision. The decision to undergo any surgery always comes with risks and benefits, and it is essential surgeons listen carefully to their patients to help guide them in making these most personal choices: “Once patients have the basic knowledge of what their options are, how they wish to proceed is completely their choice.”

Dr. Barr’s philosophy of treatment focuses on overcoming illness and fear, and living in the solution: “Whether medical studies prove it or not, some women are experiencing illness. Microsomal oxidation inhibitors (including cimetidine, fluvoxamine, ketoconazole, omeprazole, fluoxetine) alter the pharmacokinetics and increase the duration of Valium effects. Rifampicin reduces the level of the drug in the blood. It is my job to listen to patients and provide them with safe and informed solutions to the issues they are experiencing”. Symptomatic or not, Dr. Barr believes in educating and encouraging women to choose what they feel would be best for their own personal health.

If you are suffering from what you believe to be Breast Implant Illness, or wish to remove them as a precautionary measure, call us today at (561) 833-4122 for a free consultation with Dr. Barr. You can feel confident and at ease, knowing you will be met by a compassionate and caring team who will always put your health concerns first.

Available Medical Studies About Breast Implant Illness

1. Sclerodermalike esophageal disease in children breast-fed by mothers with silicone breast implants. https://pubmed.ncbi.nlm.nih.gov...
2. Immune functional impairment in patients with clinical abnormalities and silicone breast implants. https://pubmed.ncbi.nlm.nih.gov...
3. Suppressed natural killer cell activity in patients with silicone breast implants: reversal upon explantation. https://pubmed.ncbi.nlm.nih.gov...
4. Silicone-induced modulation of natural killer cell activity. https://pubmed.ncbi.nlm.nih.gov...
5. An association of silicone-gel breast implant rupture and fibromyalgia. https://pubmed.ncbi.nlm.nih.gov...
6. Antibody to silicone and native macromolecules in women with silicone breast implants. https://pubmed.ncbi.nlm.nih.gov...
7. Cellular immune reactivities in women with silicone breast implants: a preliminary investigation. https://pubmed.ncbi.nlm.nih.gov...
8. Breast implant-associated anaplastic large cell lymphoma: a systematic review. https://pubmed.ncbi.nlm.nih.gov...
9. Silicone breast implant rupture presenting as bilateral leg nodules. https://pubmed.ncbi.nlm.nih.gov...
10. Intrapulmonary and cutaneous siliconomas after silent silicone breast implant failure. https://pubmed.ncbi.nlm.nih.gov...
11. Silicon granuloma mimicking lung cancer. https://pubmed.ncbi.nlm.nih.gov...
12. Neck lymphadenitis due to silicone granuloma. https://pubmed.ncbi.nlm.nih.gov...
13. Silicone Toxicology. https://pubmed.ncbi.nlm.nih.gov...
14. Locoregional silicone spread after high cohesive gel silicone implant rupture. https://pubmed.ncbi.nlm.nih.gov...
15. Silicon granulomas and dermatomyositis like changes associated with chronic eyelid edema. https://pubmed.ncbi.nlm.nih.gov...
16. Demonstration of silicon in the sites of connective-tissue disease in patients with silicone gel breast implant. https://pubmed.ncbi.nlm.nih.gov...
17. Systemic sclerosis after augmentation with silicone breast implants. https://pubmed.ncbi.nlm.nih.gov...
18. Human adjuvant disease following augmentation mammoplasty. https://pubmed.ncbi.nlm.nih.gov...
19. Increase urinary NO3(-) + NO2- and neopterin excretion in children breast fed by mothers with silicone breast implants: evidence for macrophage activation. https://pubmed.ncbi.nlm.nih.gov...
20. Espophageal dysmotility in children breast-fed by mother with silicone breast implants. Long term followup and response to treatment. https://pubmed.ncbi.nlm.nih.gov...
21. Silicone gel breast implant rupture, extracapsular silicone, and health status. https://pubmed.ncbi.nlm.nih.gov...
23. Microscopic Polyangiitis following silicone exposure from breast implants. https://pubmed.ncbi.nlm.nih.gov...
24. Left unilateral breast autoinflation https://pubmed.ncbi.nlm.nih.gov...
25. The semi-permeability of silicone: a saline-filled breast implant with Aspergillus flavus (fungus). https://pubmed.ncbi.nlm.nih.gov...
26. Paecilomyces variotii contamination in the lumen of a saline filled breast implant. https://pubmed.ncbi.nlm.nih.gov...
27. Microbial growth inside saline filled breast implants. https://pubmed.ncbi.nlm.nih.gov...
28. Detection of subclinical infection in significant breast implant capsules https://pubmed.ncbi.nlm.nih.gov...
29. Infections in breast implants. https://pubmed.ncbi.nlm.nih.gov...
30. Vertical Transmission of Babesiosis Microti, US https://www.ncbi.nlm.nih.gov/pmc/art...
31. Current management of human granulocytic anaplasmosis, human monocytic ehrlichiosis and Ehrlichia ewingii ehrlichiosis https://www.ncbi.nlm.nih.gov/pmc/art...
32. Importance of histological analysis of seroma fluid to check for ALCL. https://pubmed.ncbi.nlm.nih.gov...
33. Promotion of variant human mammary epithelial cell outgrowth by ionizing radiation: an agent-based model supported by in vitro studies. https://pubmed.ncbi.nlm.nih.gov...
34. Implant infection after augmentation mammaplasty: a review of the literature and report of a multidrug-resistant Candida albicans infection. https://pubmed.ncbi.nlm.nih.gov21717259
35. Stimulation of T lymphocytes by silica after use of silicone mammary implants. https://pubmed.ncbi.nlm.nih.gov...
36. Severe Asia Syndrome associated with lymph node, thoracic and pulmonary penetration by silicone https://m.lup.sagepub.com/content/24...
37. Rupture and intrapleural migration of Cohesive Silicone Gel Implant https://asaps.confex.com/asaps/2011...
38. Lipogranulomatosis and hypersplenism induced by ruptured silicone breast implants https://m.bloodjournal.org/content/1...
39. The spectrum of ASIA: ‘Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants’ https://m.lup.sagepub.com/content/21...
40. Intrapulmonary and cutaneous siliconomas after silent silicone breast implant failure https://pubmed.ncbi.nlm.nih.gov...
41. Silicone breast implant rupture presenting as bilateral leg nodules https://pubmed.ncbi.nlm.nih.gov...
42. Microbial Growth Inside Saline Implants: https://pubmed.ncbi.nlm.nih.gov...
43. Endocrine activity of persistent organic pollutants accumulated in human silicone implants–Dosing in vitro assays by partitioning from silicone. https://www.ncbi.nlm.nih.gov/m/pubm...
44. Residual silicone detection using mri following previous breast implant removal: Case reports https://link.springer.com/article/10...
45. Complications related to retained breast implant capsules https://pubmed.ncbi.nlm.nih.gov...
46. TILT – Toxicity Syndrome Introduced by Metals and Chemicals including Breast Implants https://drclaudiamiller.com/category...
47. Silicone breast implants and autoimmunity: causation, association, or myth? https://pubmed.ncbi.nlm.nih.gov...
48. Adjuvant Breast Disease: An Evaluation of 100 Symptomatic Women with Breast Implants Or Silicone Injections and a picture of silicone in breast milk ducts from a ruptured silicone breast implant. https://www.jstage.jst.go.jp/articl...
49. Anti-collagen autoantibodies are found in women with silicone breast implants. https://pubmed.ncbi.nlm.nih.gov...
50. Silicone Review: https://alt.support.breast-implant.narkive.com/...
51. Silicone breast implant associated musculoskeletal manifestations https://pubmed.ncbi.nlm.nih.gov...
52. Silicone breast prosthesis and rheumatoid arthritis: a new systemic disease: siliconosis. A case report and critical review of the literature. https://pubmed.ncbi.nlm.nih.gov...
53. Breast implant associated anaplastic large cell lymphoma: a case report and reconstructive option. https://pubmed.ncbi.nlm.nih.gov...
54. Radiological trap and oncological precautions in a patient who has undergone a permanent withdrawal of PIP breast implants. https://pubmed.ncbi.nlm.nih.gov...
55. Late massive breast implant seroma in postpartum. https://pubmed.ncbi.nlm.nih.gov...
56. Late seroma during pregnancy, a rare complication in prosthetic breast augmentation a case report: https://pubmed.ncbi.nlm.nih.gov...
57. Talc deposition in skin and tissues surrounding silicone gel-containing prosthetic devices. https://pubmed.ncbi.nlm.nih.gov...
58. Silicone breast implants, autoimmunity and the gut. https://www.ncbi.nlm.nih.gov/pmc/art...
59. Silicone breast implant-induced lymphadenopathy: 18 Cases https://www.sciencedirect.com/scienc...
60. Is explantation of silicone breast implants useful in patients with complaints?https://link.springer.com/article/10...
61. Seroma in Prosthetic Breast Reconstruction https://pubmed.ncbi.nlm.nih.gov...
62. Severe manifestation of autoimmune syndrome induced by adjuvants (Shoenfeld’s Syndrome) https://pubmed.ncbi.nlm.nih.gov...
63. Hypercalcemia as a consequence of modern cosmetic treatment with liquid silicone https://www.ncbi.nlm.nih.gov/pmc/art...
64. Endocrine activity of persistent organic pollutants accumulated in human silicone implants: https://www.ncbi.nlm.nih.gov/m/pubm...
65. The Dark Side of Breast Implants by Frank Vasey: https://www.nyjsm.com/Medicine/Rheumatology/Silicone_Syndrome_Frank_Vasey_ MD.cfm
66.The Breast Implant Working Groups Breast Implant Black Box Warning and Patient Checklist
67. Talking Points
68. Breast Implant Illness: A Way Forward
69. FDA proposes “black-box warning” for breast implants – its strongest form of caution

Disclaimers:

As a result of the En Bloc procedure there may be negative cosmetic consequences such as but no limited to the following: scaring, contour irregularities, asymmetry, volume loss and indentations.
There are no guarantees that BII symptoms will be resolved after En Bloc procedure.

Before and After Photos*

BII eCourse

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Our Faqs

Q

If I am seeking to undergo a combination of procedures, will they be done together or consecutively? What is the timeline for multiple procedures?

A

The answer depends on multiple factors, including the specific combination of procedures, your recovery rates, your age and health status, and your behaviors or habits. More invasive surgeries typically require recovery time ranging between 6 and 12 weeks to 6 months, and surgeries to the same area of your body will also generally require recovery time between procedures.

However, if you are in good health and the combination of procedures in question will be performed on different parts of your body and are not especially invasive, a combination of procedures could potentially be approved together on a case-by-case basis. It is imperative that the combination of procedures does not compromise your healing, and your attention to prescribed pre-operation and recovery habits also plays a significant role. Schedule a consultation for an assessment and guidance regarding the procedures you are considering.


Q

Will it be obvious that I “got work done” after my procedure?

A

While aging affects us all, there are steps we can take to put forth a more vibrant appearance. We seek to perform subtle adjustments to address imperfections and the wear of time while retaining your natural look. While you should notice an improvement, the glaring changes or distortions in appearance you are concerned about and may have seen from other surgeons’ work do not meet the standard of quality plastic and cosmetic surgery we perform in our office.

Dr. Frederic M. Barr is a board-certified Plastic & Cosmetic Surgeon with over 30 years of experience performing Plastic Surgery in South Florida. We enhance and refine your appearance according to your goals. Review our Gallery of Before & After Photos to see some examples of our work.


Q

What does Breast Explant Surgery entail, and will my breasts be “back to normal” after the surgery?

A

For patients with Breast Implant Illness (BII), which can include allergy, auto-immune, and thyroid hormone issues, this has been an emerging topic with significant press coverage in recent years. Although numerous medical professionals have demonstrated varying responses to these women’s concerns, we believe in addressing these women’s experiences and symptoms. In response to this phenomenon, we have also chosen not to perform new breast implant surgeries. We perform En Bloc Capsulectomy on patients with breast implants, which involves the removal of both the saline or silicone implant and the capsule around it.

Removal of the implants and surrounding scar tissue has been shown to improve women’s health concerning these symptoms. While some women choose no further procedure following Breast Explant Surgery, some patients elect to have a Mastopexy procedure that involves reshaping the breast tissue for a pleasant cosmetic breast appearance. We welcome your specific questions regarding these procedures and their anticipated effects for your situation. See our Breast Implant Explantation (En Bloc) page for more detailed information, including before-and-after photo examples.


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