Breast Implants and Complications

Practical Advice for GPs

Rod Cooter AM MD FRACSAdelaide, Australia, May 2019

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• No financial association with any

biomedical company

• Specifically no financial payment from any

implant company

Disclosures

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Breast Augmentation - Increased Demand

2000

212,500 Implants

2017

300,378 Implants

2018

313,735 Implants

FUTURE

Ref. USASPS National Plastic Surgery Statistics

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Breast Implants – Beneficial Evidence

…“breast augmentation significantly improves satisfaction with breast appearance, psychological well-being, and sexual well-being”…

…“overall satisfaction is most strongly correlated with breast appearance satisfaction”…

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Common Reasons for Choosing Breast Implants

• Always had small breasts

• Loss of volume (afterbreast feeding)

• Major weight loss

• Unequal breasts

• After breast cancer surgery

• After risk reducing mastectomy

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1890sFat Paraffin Glass balls Ivory

1940sWWII Japanese prostitutes injected industrial silicone to enlarge breasts

1950sIvalon sponges Polyethylene Polyether nylon Polyurethane Teflon

1960sMedical grade silicone injections

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Evolution of Breast Augmentation

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Late 19th Century

Silicone invented as polymer of silicone dioxide

1940sLubricant used in WWII

1950sHydrocephalus shunts

1960s1st breast implant

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Evolution of Silicone

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1960sThick walls, fixation patches, capsular contractures

1970sThinner walls, bleed rate, ruptures, extravasation

1980s / 1990s

More viscous gels

Textured surfaces

2000sMatrix of shapes

2010Nano texture Microchips

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Evolution of Silicone Breast Implants

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Implant Extraction Video

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Ruptured Implant

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Variety of Implants

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Microchip in Implant

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Current Breast Implant Issues

1. Conflict of interest in literature

2. Breast implant associated Anaplastic Large Cell Lymphoma (BIA-ALCL) & Regulation

3. Breast Implant Illness (BII)& Social Media

4. Surgical Tourism & Internet Consultations

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Conflict of Interest around Breast Implants

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1990Dow Crisis

2010PIP Crisis

2012Senate inquiry

2013ASERNIP-S review

CURRENTBIA-ALCL BII Surgical tourism

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Silicone Implant Controversies

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PIP Implant Cavity with Milky Solution

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Quorum Flow Chart

• Ref: Breast prosthesis implantation for reconstructive and cosmetic surgery: a rapid review by GurgaczSL, Lambert RS, Vogan A, Cooter R, Mutimer K, and Maddern G

Conflict of

Interest

Concerns

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JAMA Conflict of

Interest Theme Issue:

Statements

“There was a higher likelihood of receipt and higher value of reported payments to surgeons than to primary care physicians”– Tringale KR, Marshall D, Mackey TK, Connor M, Murphy JD, Hattangadi-Gluth JA. Types and distribution of payments from industry to physicians in 2015. Jama. 2017 May 2;317(17):1774-84.

“The greater the financial interest, the greater the likelihood professional judgment will be biased, and the more severe the COI.”– McCoy MS, Emanuel EJ. Why there are no “potential” conflicts of interest. Jama. 2017May 2;317(17):1721-2.

“It seems plausible that very large payments warrant greater concern about conflict of interest causing bias and undue influence.”- Lo B, Grady D. Payments to physicians: does the amount of money make a difference?.Jama. 2017 May 2;317(17):1719-20.

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Plastic Surgeons Receiving Industry

Payments

Sl. No.

Paper TitleYear

publishedPayments –

Year published(Year

published)-1(Year

published)-2Total* - All

years

1Ten-year results from the Natrelle 410 anatomical form-stable silicone breast implant core study

2015 $5,122,999.36 $5,678,849.89 $2,872,597.36$13,674,446.6

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2Long-term outcomes with the McGhanStyle 153 dual-lumen breast implant: Implications for future implant design.

2016 $410,082.33 $325,685.18 $327,466.09 $1,063,233.60

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Comparison of Allergan, Mentor, and Sientra Contoured Cohesive Gel Breast Implants: A Single Surgeon's 10-Year Experience

2015 $14,183.49 $35,155.38 $13,323.62 $62,662.49

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What Is the Optimum Timing of Postmastectomy Radiotherapy in Two-Stage Prosthetic Reconstruction: Radiation to the Tissue Expander or Permanent Implant?

2015 $18,165.17 $104,516.09 $30,279.13 $153,827.24

5Natrelle round silicone breast implants: core study results at 10 years.

2014 $30,519.48 $54,274.82 $0.00 $84,794.30

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Nine-Year Core Study Data for Sientra'sFDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel

2016 $66,930.76 $47,560.03 $68,586.31 $183,077.10

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Eight-year follow-up data from the U.S. clinical trial for Sientra's FDA-approved round and shaped implants with high-strength cohesive silicone gel

2015 $30,873.27 $58,452.28 $68,505.45 $157,831.00

8Natrelle 410 Extra-Full Projection Silicone Breast Implants: 2-Year Results from Two Prospective Studies

2015 $158,032.20 $330,075.75 $163,007.88 $651,115.83

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Understanding the effect of breast augmentation on quality of life. prospective analysis using the BREAST-Q

2014 $38,618.95 $8,909.16 $0.00 $47,528.11

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Implant breast reconstruction and radiation: a multicenter analysis of long-term health-related quality of life and satisfaction

2014 $148,743.01 $39,521.38 $0.00 $188,264.39

* Data was unavailable for some surgeons / years.19

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Plastic Surgery Literature Conundrum

If Conflict of Interest is not transparent in our literature,

and

Literature is basis for formulating clinical guidelines,

it is problematic because guidelines tell us what we

should be doing.

Question: How can we generate meaningful data?

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Answer: Clinical Quality Registries

because robust registries tell us

what we are doing!

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Breast Implant Registry (BIR) established 1998

BIR recorded less than 4% PIP implants *Insufficient data to make explant recommendations to our government*

ABDR established on recommendation by Australian Senate enquiry following PIP crisis

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Australian Breast Device Registry

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Data from 38,343 patients relating to 79,554 breast devices

• 1.1% patient opt out rate

• 269 sites and 491 surgeons contributing nationally

• Completed first rounds of surgeon and site reporting

• Collecting Patient Reported Outcome Measures at 1, 2, 5, 10 years

AT 12 MARCH 2019

Current Situation

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2017 ABDR annual report

Issues Identified – Primary Implants

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Capsular Tissue

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The ICOBRA project is designed to pick up low frequency events such as ALCL among patients with breast implants

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Breast Implant Associated Anaplastic Large Cell Lymphoma

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Anaplastic T-cell Lymphoma association with

breast implants first reported 1997

Ref: Keech JA & Creech BJAnaplastic T-cell Lymphoma in Proximity to a Saline Filled Breast ImplantPlast Reconstr Surg 1997;100(2) :554-555

BIA-ALCL

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• This is a rare tumour

• WHO Classification of Lymphomas

- now recognised as a distinct entity

• ALCL is a rare type of NHL

• Surveillance, Epidemiology, and End Results (SEER)program of the NCI statistics;-

–3: 100,000,000 ALCLs in breast / year

BIA-ALCL Perspective

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• Two major variants of ALCL

– One expresses the protein anaplastic lymphoma kinase (ALK+)

– One does not express anaplastic lymphoma kinase (ALK-)

• BIA – ALCL are (ALK-)

BIA-ALCL

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• BIA – ALCL are CD30 positive CD30 antigen is a transmembrane glycoprotein

member of the tumour necrosis factor (TNF) receptor superfamily

CD30 expression in neoplastic cells is mainly positive in lymphoid neoplasms:

• Hodgkins lymphoma

• Anaplastic large cell lymphoma

• Primary cutaneous T-cell lymphoma

BIA-ALCL

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Clinical Results – BIA-ALCL

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BIA-ALCL Epidemiology

Plast Reconstr Surg. 2019 May;143(5):1285-1292.

The Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand Confirms the Highest Risk for Grade 4 Surface Breast Implants.

Magnusson M1, Beath K, Cooter R, Locke M, Prince HM, Elder E, Deva AK.

BACKGROUND:The epidemiology and implant-specific risk for breast implant-associated (BIA) anaplastic large cell lymphoma (ALCL) has been previously reported for Australia and New Zealand. The authors now present updated data and risk assessment since their last report.

CONCLUSIONS:The number of confirmed cases of BIA-ALCL in Australia and New Zealand continues to rise. The implant-specific risk has now changed to reflect a strong link to implant surface area/roughness as a major association with this cancer.

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Textured Surfaces

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Epidemiology of BIA-ALCL

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Breast Implant Illness and Social Media

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Breast Implant Illness (BII)

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Breast Implant Illness (BII)

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Breast Implant Illness (BII)

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Breast Implant Illness (BII)

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BII: Blogs and Social Media Influence

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BII: Blogs and Social Media Influence

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BII: Blogs and Social Media Influence

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Surgical Tourism and Internet Consultations

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Surgical Tourism on Social Media

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Surgical Tourism on Social Media

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Surgical Tourism

ANZ J Surg. 2018 Sep;88(9):842-847. doi: 10.1111/ans.14326. Epub 2017 Dec 3.

Cosmetic tourism for breast augmentation: a systematic review.Brightman L1,2, Ng S1,2, Ahern S1,2, Cooter R1,2, Hopper I1,2.

RESULTS:We identified 17 observational studies. Common destinations included Europe, South America and South East Asia. Infectious complications were common. Wound dehiscence and aesthetic dissatisfaction also featured. Catastrophic outcomes such as sepsis, intubation and ventilation, radical bilateral mastectomy, irreversible hypoxic brain injury and death were also reported. There were expectations that home country health systems would treat complications and provide non-medically indicated revision procedures. The burden on home country health systems was evident from a public health perspective.

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Surgical Tourism Survey

EXPLANATORY STATEMENT

(For ICOPLAST delegates and their respective national society members)

Determining ICOPLAST members’ interest in the development of and international framework for informed consent

Chief Investigators: Dr Rodney Cooter and Dr Louise BrightmanDepartment of Epidemiology and Preventive Medicine

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Game of Implants

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Game of Implants

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Game of Implants

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Practical Advice

Patients seeking breast implants

• Not lifetime devices: 10-15 year exchanges

• Ensure surgeon contributes data to ABDR

• See surgeon twice before procedure with a 7-10 day cooling off period

• Seek fully informed financial consent especially for post-op problems

• If considering surgical tourism, take an ABDR formfor surgeon to complete

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Practical Advice

Patient with breast implants

• Annual check

• BSE and regular MMG with Eklund maneuvre

• U/S as alternate breast screen +/- MRI

• Ruptured cohesive gel implant cannot be diagnosed on clinical exam

• U/S over calls rupture, MRI is best

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Practical Advice

Actively swollen breast

• Suspect anaplastic large cell lymphoma

• Examine for lymphadenopathy (axilla, neck) ultrasound guided fluid aspiration and request CD30, ALK status

• Reassure patient can be cured in early stage

• Urgent referral to plastic surgeon

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Practical Advice

Lethargy, Joint Pains, Brain Fog

• Exclude other pathology

• Rheumatologist, Immunologist referrals asappropriate

• Caution patient that explanting implants may have no effect on symptoms

• Once implants are removed there may be norebate from Medicare for re-alignment at a later date

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Implant with Tabs

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Thank You

Rod Cooter AM MD FRACSPlastic Surgeon, Adelaide

Clinical Professor, Monash Universityrdcooter@plasticsurgeryadelaide.com

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