Evaluation of papers received during the call for information · Chenard-Neu, A. M. Tasei, E....

1

Evaluation of papers received during the call for information

No Title Contribu

tor

Authors Journal Year Peer

review

ed

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gn

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usion criteria

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size

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Comments

1 France's answer to

SCHEER request

for a call for data

ANSM ANSM Letter to DG

SANTE

No other Letter to DG SANTE

on French (ongoing)

evaluation)

2 PIP data - medical

vigilance replorts

update

ANSM ANSM 2016 No other 18667

(32433

explant

s)

Overview PIP side

effects in France.

Not specifically

dealing with ALCL.

3 cases of ALCL

reported

3 Breast implant-

associated

anaplastic large

cell lymphomas

ANSM Institut National

du Cancer

No other 18 Expert Group

Opinion

4 Breast implant-

associated

analplastic large

cell lymphoma

and state of the

french breast

implant market

ANSM ANSM 2016 No obs 29 Report on French

cases of ALCL

5 Anaplastic large

cells lymphoma

associated with

breast implants

(ALCL-AIM):

Update on

ongoing

investigations -

Information Point

ANSM ANSM 2016 No other Information

brochure on ALCL

6 Temporary

specialist scientific

committee

"breast implant

biocompatibility

evaluation

strategy" meeting

ANSM ANSM 03/201

6

No other Minutes of meeting

French expert

panel. Conclusion

on need to perform

biocompatibility

testing for SBI

brands.

2

No Title Contribu

tor


review

ed

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y

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gn

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usion criteria

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size

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Comments

minutes

7 Scientific

specialized

temporary

Committee breast

implants and

large cells

lymphoma-

MINUTES

ANSM ANSM 03/201

5


expert panel

France.

8 Scientific

specialized

temporary

Committee «

breast implants

and

large cells

lymphoma » -

MINUTES

ANSM ANSM 04/201

5


expert panel

France.

9 Scientific

specialized

temporary

Committee «

breast implants

and

large cells

lymphoma » -

MINUTES

ANSM ANSM 06/201

5


expert panel

France.

10 Temporary

Specialist scientific

committee

"Breast implant

biocompatibility

evaluation

strategy"

MEETING

ANSM ANSM 02/201

6


expert panel

France.

3

No Title Contribu

tor


review

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y

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gn

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Comments

MINUTES

11 Guideline for

demonstrating

textured breast

implant

biocompatibility

ANSM ANSM 2016 No other Guidance oon which

teste to perform for

biocompatibility

testing.

12 Biocompatibility of

implants textured:

Results of

investigations -

Information Point

ANSM ANSM 2016 No other Information/newslet

ter on ALCL and

biocompatibility of

SBI brands.

13 Biological Growth

and Toxin Release

in Silicone Breast

Implants as a

Cause for Adverse

Events?

Dr

Reinmull

er

Dr Reinmuller Vereinigung

für

Allgemeine

und

Angewandte

Mikrobiologie

[VAAM]

2016 Yes obs Abstract of poster

of scientific

meeting. Inventory

of SBI explants.

14 Biomarkers

Provide Clues to

Early Events in

the Pathogenesis

of Breast Implant-

Associated

Anaplastic Large

Cell Lymphoma

Ekaterina

Mirkova

Marshall E.

Kadin, MD;

Anand Deva,

MD; Haiying Xu,

BS;

John Morgan,

PhD; Pranay

Khare, PhD;

Roderick A.F.

MacLeod, PhD;

BruceW. Van

Natta,MD;Willia

m P. Adams

Jr.,MD; Garry S.

Brody,MD;

and Alan L.

Epstein,MD, PhD

Aesthetic

Surgery

Journal

2016 Yes obs 6 Comparison of BIA-

ALCL with

cutaneous ALCL

(n=3 per tumor).

Identifies

biomarkers in ALCL.

See 42.

4

No Title Contribu

tor


review

ed

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y

desi

gn

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usion criteria

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size

Outco

me

Comments

15 The 2016 revision

of the World

Health

Organization

classification of

lymphoid

neoplasms

Ekaterina

Mirkova

Steven H.

Swerdlow, Elias

Campo, Stefano

A. Pileri, Nancy

Lee Harris,

Harald Stein,

Reiner Siebert,

Ranjana Advani,

Michele

Ghielmini,8

Gilles A.

Salles,9 Andrew

D. Zelenetz,10

and Elaine S.

Jaffe11

BLOOD 2016 Yes other New provisional

entity distinguished

from other ALK2

ALCL; non-invasive

disease associated

with excellent

outcome. Also 59.

16 Breast Implant-

Associated

Anaplastic Large

Cell Lymphoma:

A Case Report and

Literature Review

Ekaterina

Mirkova

Mei-Ju Hwang,

Hamish Brown,

Richard Murrin

Navid

Momtahan,Guy

D. Sterne

Aesth Plast

Surg

2015 Yes cs 1 Statement in paper.

Breast implant-

associated

anaplastic large cell

lymphoma (ALCL) is

a rare new clinical

entity. The

incidence is 0.3 %

per 100,000 women

per year.

17 ASPS Statement

on Breast Implant

Specimens and

Pathology

Ekaterina

Mirkova

American

Society of

Plastic Surgeons

? No other Statement of

scientific society

(Americam Society

of Plastic Surgeons

18 Skin involvement

as the first

manifestation of

breast implant-

associated

anaplastic large

cell lymphoma

Ekaterina

Mirkova

Rebeca Alcalá,

Beatriz

Llombart, Javier

Lavernia, Víctor

Traves, Carlos

Guillén and

Onofre

Sanmartín

2016 Yes cs 1 Case report

19 Breast implant-

associated alcl

Ekaterina

Mirkova

No submission

registered

5

No Title Contribu

tor


review

ed

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y

desi

gn

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er

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usion criteria

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size

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me

Comments

20 Breast implant-

associated

anaplastic large

cell lymphoma:

two distinct

clinicopathological

variants with

different outcomes

Ekaterina

Mirkova

C. Laurent, A.

Delas, P.

Gaulard, C.

Haioun, A.

Moreau, L.

Xerri, A.

Traverse-

Glehen, T.

Rousse, I.

Quintin-Roue, T.

Petrella, J. F.

Emile, N.

Amara, P.

Rochaix1, M. P.

Chenard-Neu,

A. M. Tasei, E.

Menet, H.

Chomarat, V.

Costes, L.

Andrac-Meyer,

J. F. Michiels, C.

Chassagne-

Clement, L. de

Leval, P.

Brousset, G.

Delsol & L.

Lamant

Annals of

Oncology

2016 Yes obs 25 Review of

lymphomas

included in registry

system. Also 43.

21 Coming of Age

Breast Implant–

Associated

Anaplastic Large

Cell Lymphoma

After 18 Years of

Investigation

Ekaterina

Mirkova

Mark W.

Clemens,

MDa,*, Roberto

N. Miranda, MD

Clin Plastic

Surg

2015 Yes other Opinion paper on

BIA-ALCL Also 53.

22 Commentary on:

Lymphomas

Associated With

Breast Implants:

A Review of the

Ekaterina

Mirkova

MarkW.

Clemens, MD,

FACS; and

Roberto N.

Miranda, MD

Breast

Surgery

2016 Yes other Comment on Rupani

et al., 2015. Also 47

6

No Title Contribu

tor


review

ed

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y

desi

gn

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size

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me

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Literature

23 Breast Implant

Informed Consent

Should Include the

Risk of Anaplastic

Large Cell

Lymphoma

Ekaterina

Mirkova

Mark W.

Clemens, M.D.,

Roberto N.

Miranda M.D.,

Charles E.

Butler, M.D

www.PRSJour

nal.com


informed consent.

Also 50.

24 Breast Implant-

Associated

Anaplastic Large

Cell Lymphoma: A

Case Report and

Literature Review

Ekaterina

Mirkova

Haley Letter ,

Baiywo Rop ,

Michele N.

Edison , Patricia

Turner

Cureus 2016 Yes cs 1 Case report

25 Locally advanced

breast implant-

associated

anaplastic

large-cell

lymphoma: a case

report of

successful

treatment with

radiation and

chemotherapy

Ekaterina

Mirkova

Christopher F.

Estes, Da

Zhang, Ruben

Reyes, Richard

Korentager,

Marilee

McGinness and

Christopher

Lominska

www.frontiers

in.org

2015 Yes cs Case report

26 Breast Implant–

associated

Anaplastic Large

Cell Lymphoma:

Updated Results

from a Structured

Expert

Consultation

Process

Ekaterina

Mirkova

Benjamin Kim,

MD, Mphil,

Zachary S.

Predmore, BA,

Soeren Mattke,

MD, DSc, Kristin

van Busum,

MPA, Courtney

A. Gidengil, MD,

MPH

www.PRSGlob

alOpen.com

2015 Yes other Expert panel

opinion on BIA-

ALCL Also 49

http://www.prsjournal.com/


http://www.frontiersin.org/

http://www.frontiersin.org/

http://www.prsglobalopen.com/


7

No Title Contribu

tor


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ed

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y

desi

gn

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usion criteria

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size

Outco

me

Comments

27 Complete Surgical

Excision Is

Essential for the

Management of

Patients With

Breast Implant–

Associated

Anaplastic Large-

Cell Lymphoma

Ekaterina

Mirkova

Mark W.

Clemens, L.

Jeffrey

Medeiros,

Charles E.

Butler, Kelly K.

Hunt, Michelle

A. Fanale,

Steven Horwitz,

Dennis D.

Weisenburger,

Jun Liu,

Elizabeth A.

Morgan, Rashmi

Kanagal-

Shamanna,

Vinita Parkash,

Jing Ning, Aliyah

R. Sohani,

Judith A. Ferry,

Neha Mehta-

Shah, Ahmed

Dogan, Hui Liu,

Nora Thormann,

Arianna Di

Napoli, Stephen

Lade, Jorge

Piccolini, Ruben

Reyes, Travis

Williams,

Colleen M.

McCarthy,

Summer E.

Hanson, Loretta

J. Nastoupil,

Rakesh Gaur,

Yasuhiro Oki,

Ken H. Young,

and Roberto N.

JOURNAL OF

CLINICAL

ONCOLOGY

2015 Yes obs 87 Evaluates survival

rate in 87 patinets.

IN general good

surviaval at 3

(93%) and 5 (89%)

years. Also 52.

8

No Title Contribu

tor


review

ed

Stud

y

desi

gn

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usion criteria

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size

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me

Comments

Miranda

28 Reply: Ekaterina

Mirkova

Prof. Dr. med.

Bernd Gerber,

Dr. med. Mario

Marx, Prof. Dr.

med. Michael

Untch, Prof. Dr.

med. Andree

Faridi

Deutsches

Ärzteblatt

International

2016 Yes other Reply to comment

on published paper.

No information on

ALCL

29 Frequently Asked

Questions (FAQ):

A Guide to

Breast Implant-

Associated

Anaplastic Large

Cell Lymp

Ekaterina

Mirkova

American

Society of

Plastic Surgeons

? No other Information on FAQ

by Americam

Society of Plastic

Surgeons

30 A Patient Death

Attributable to

Implant-Related

Primary Anaplastic

Large Cell

Lymphoma of the

Breast

Katie

Sommers

Matthew J.

Carty, M.D.,

Julian J. Pribaz,

M.D., Joseph H.

Antin, M.D.,

Elgida R.

Volpicelli, M.D.,

Christiana E.

Toomey, B.A.,

Evan A.

Farkash, M.D.,

Ephraim P.

Hochberg, M.D.

www.PRSJour

nal.com

2011 Yes cs 1 Case report



9

No Title Contribu

tor


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y

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usion criteria

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size

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Comments

31 Biomarkers

Provide Clues to

Early Events in the

Pathogenesis of

Breast Implant-

Associated

Anaplastic Large

Cell Lymphoma

Katie

Sommers

Marshall E.

Kadin, MD;

Anand Deva,

MD; Haiying Xu,

BS;

John Morgan,

PhD; Pranay

Khare, PhD;

Roderick A.F.

MacLeod, PhD;

BruceW. Van

Natta,MD;Willia

m P. Adams

Jr.,MD; Garry S.

Brody,MD;

and Alan L.

Epstein,MD, PhD

Breast

Surgery

2016 Yes other Comparison of BIA-

ALCL with

cutaneious ALCL

(n=3 per tumor).

Idientifies

biomarkers in ALCL.

See 25.

32 Breast implant-

associated

anaplastic large

cell lymphoma:

two distinct

clinicopathological

variants with

different outcomes

Katie

Sommers

C. Laurent, A.

Delas, P.

Gaulard, C.

Haioun, A.

Moreau, L.

Xerri, A.

Traverse-

Glehen, T.

Rousse, I.

Quintin-Roue, T.

Petrella, J. F.

Emile, N.

Amara, P.

Rochaix1, M. P.

Chenard-Neu,

A. M. Tasei, E.

Menet, H.

Chomarat, V.

Costes, L.

Andrac-Meyer,

J. F. Mic

Annals of

Oncology

2016 Yes obs 25 Review of

lymphomas

included in regeistry

system. Also 31.

10

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tor


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y

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gn

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usion criteria

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size

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33 Discussion:

Anaplastic Large

Cell Lymphoma

Occurring in

Women with

Breast Implants:

Analysis of 173

Cases

Katie

Sommers

William P.

Adams, Jr.,

M.D.

www.PRSJour

nal.com

2015 Yes other Discussion on paper

of Brody et al that

reports 173 cases of

ALCL.

34 Breast implant-

associated

anaplastic large

cell lymphoma:

sensitivity,

specificity, and

findings of

imaging studies in

44 patients

Katie

Sommers

Beatriz E.

Adrada •

Roberto N.

Miranda •

Gaiane

Margishvili

Rauch •

Elsa Arribas •

Rashmi

Kanagal-

Shamanna •

Mark W.

Clemens •

Michelle Fanale

•

Nisreen Haideri

• Eid Mustafa •

John Larrinaga •

Neal R. Reisman

•

Jesse Jaso • M.

James You •

Ken H. Young •

L. Jeffrey

Medeiros •

Wei Yang

Breast Cancer

Res Treat

2014 Yes other 44 Discusses method

of diagnosis for

ALCL. Suggets

under diagnosis.

35 Anaplastic Large

Cell Lymphoma

Occurring in

Women with

Breast Implants:

Katie

Sommers

Garry S. Brody,

M.D., M.Sc.

Dennis Deapen,

Dr.Ph.

Clive R. Taylor,

www.PRSJour

nal.com

2015 Yes obs 173 Review of literature.

Identifies 173 cases

of ALCL.





11

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tor


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gn

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usion criteria

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size

Outco

me

Comments

Analysis of 173

Cas

M.D.,

D.Phil.

Lauren Pinter-

Brown, M.D.

Sarah Rose

House-Lightner,

B.A.

James S.

Andersen, M.D.

Grant Carlson,

M.D.

Melissa G.

Lechner, Ph.D.

Alan L. Epstein,

M.D.,

Ph.D.

36 Commentary on:

Lymphomas

associatedwith

Breast Implants:

A Review of the

Literature

Katie

Sommers

MarkW.

Clemens, MD,

FACS; and

Roberto N.

Miranda, MD

Aesthetic

Surgery

Journal

2015 Yes other Comment on Rupani

et al., 2015. Also 33

37 Implant-

Associated

Primary Anaplastic

Large-Cell

Lymphoma With

Simultaneous

Involvement of

Bilateral Breast

Capsules

Katie

Sommers

Marnelli A.

Bautista-Quach,

Auayporn

Nademanee,

Dennis D.

Weisenburger,

Wengang Chen,

Young S. Kim

Clinical

Breast Cancer

2013 Yes cs 1 Bilateral breast

involvement of

ALCL


associated

Anaplastic Large

Cell Lymphoma:

Updated Results

from a Structured

Expert

Consultation

Katie

Sommers

Benjamin Kim,

MD, MPhil

Zachary S.

Predmore, BA

Soeren Mattke,

MD, DSc

Kristin van

Busum, MPA

www.PRSGlob

alOpen.com

2014 Yes other Expert panel

opinion on BIA-

ALCL Also 37.



12

No Title Contribu

tor


review

ed

Stud

y

desi

gn

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usion criteria

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size

Outco

me

Comments

Process Courtney A.

Gidengil, MD,

MPH

39 Breast Implant

Informed Consent

Should Include the

Risk of Anaplastic

Large Cell

Lymphoma

Katie

Sommers

Mark W.

Clemens, M.D.

Roberto N.

Miranda, M.D.

Charles E.

Butler, M.D.

www.PRSJour

nal.com


informed consent.

Also 34.

40 Chronic Biofilm

Infection in Breast

Implants Is

Associated with an

Increased T-Cell

Lymphocytic

Infiltrate:

Implications for

Breast Implant–

Associated

Lymphoma

Katie

Sommers

Honghua Hu,

Ph.D.

Anita Jacombs,

M.B.B.S.,

M.S.

Karen Vickery,

Ph.D., B.V.Sc.

Steven L.

Merten,

F.R.A.C.S.

David G.

Pennington,

F.R.A.C.S.(Ed.),

F.R.A.C.S.

Anand K. Deva,

M.D.

www.PRSJour

nal.com

2015 Yes obs 57 Demostrates

relation biofilm and

proliferating T

lymphocyes in bot

animal (pi)

implantation study

and explants.

41 Complete Surgical

Excision Is

Essential for the

Management of

Patients With

Breast Implant–

Associated

Anaplastic Large-

Cell Lymphoma

Katie

Sommers

Mark W.

Clemens, L.

Jeffrey

Medeiros,

Charles E.

Butler, Kelly K.

Hunt, Michelle

A. Fanale,

Steven Horwitz,

Dennis D.

Weisenburger,

JOURNAL OF

CLINICAL

ONCOLOGY

2015 Yes obs 87 Evaluates survival

rate in 87 patinets.

IN general good

surviaval at 3

(93%) and 5 (89%)

years. Also 38.



13

No Title Contribu

tor


review

ed

Stud

y

desi

gn

Cent

er

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usion criteria

Sample

size

Outco

me

Comments

Jun Liu,

Elizabeth A.

Morgan, Rashmi

Kanagal-

Shamanna,

Vinita Parkash,

Jing Ning,

Aliyah R.

Sohani, Judith

A. Ferry, Neha

Mehta-Shah,

Ahmed Dogan,

Hui Liu, Nora

Thormann,

Arianna

DiNapoli,

Stephen Lade,

Jorge Piccolini,

Ruben Reyes,

Travis Williams,

Colleen M.

McCarthy,

Summer E.

Hanson, Loretta

J. Nastoupil,

Rakesh Gaur,

Yasuhiro Oki,

Ken H. Young,

and Roberto N.

Miranda

42 Coming of Age

Breast Implant–

Associated

Anaplastic Large

Cell Lymphoma

After 18 Years of

Investigation

Katie

Sommers

Mark W.

Clemens,

MDa,*, Roberto

N. Miranda,

MDb

Clin Plastic

Surg


BIA-ALCL Also 32.

14

No Title Contribu

tor


review

ed

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y

desi

gn

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usion criteria

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size

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43 Anaplastic Large-

Cell Lymphoma in

Women With

Breast Implants

Katie

Sommers

Daphne de

Jong, MD, PhD

Wies L. E.

Vasmel, MD,

PhD

Jan Paul de

Boer, MD, PhD

Gideon Verhave,

MD

Ellis Barbe´, MD

Mariel K.

Casparie, MD,

PhD

Flora E. van

Leeuwen, PhD

JAMA 2008 Yes obs 11 Describes 11 cases

of ALCL. ALCL

considered rare as

11 cases were

identified in the

Netherlands in 17

years.

15

No Title Contribu

tor


review

ed

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y

desi

gn

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usion criteria

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size

Outco

me

Comments


Associated

Anaplastic Large-

Cell Lymphoma:

Long-Term Follow-

Up of 60 Patients

Katie

Sommers

Roberto N.

Miranda, Tariq

N. Aladily, H.

Miles Prince,

Rashmi

Kanagal-

Shamanna,

Daphne de

Jong,

Luis E. Fayad,

Mitual B. Amin,

Nisreen Haideri,

Govind Bhagat,

Glen S. Brooks,

David A. Shifrin,

Dennis P.

O’Malley, Chan

Y. Cheah, Carlos

E. Bacchi,

Gabriela Gualco,

Shiyong Li, John

A. Keech Jr,

Ephram P.

Hochberg,

Matthew J.

Carty, Summer

E. Hanson, Eid

Mustafa, Steven

Sanchez, John

T. Manning Jr,

Zijun Y. Xu-

Monette, Alonso

R. Miranda,

Patricia Fox,

Roland L.

Bassett, Jorge J.

Castillo, Brady

E. Beltran, Jan

Paul de Boer,

Zaher

Chakhachiro,

Dongjiu Ye,

Douglas Clark,

Ken H. Young,

and L. Jeffrey

Medeiros

JOURNAL OF

CLINICAL

ONCOLOGY

2013 Yes obs 60 Follow up on

survival of 60 ALCL

patients. Depending

on locatin and form

of ALCL limited

treatment mayn be

sufficient.

16

No Title Contribu

tor


review

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size

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Comments

45 Managing Late

Periprosthetic

Fluid Collections

(Seroma) in

Patients with

Breast Implants:

A Consensus Panel

Recommendation

and Review of the

Literature

Katie

Sommers

Bradley

Bengtson, M.D.

Garry S. Brody,

M.D. Mitchell H.

Brown, M.D.

Caroline

Glicksman, M.D.

Dennis

Hammond, M.D.

Hilton Kaplan,

M.D., Ph.D. G.

Patrick Maxwell,

M.D. Michael G.

Oefelein, M.D.

Neal R.

Reisman, M.D.,

J.D. Scott L.

Spear, M.D.

Mark L. Jewell,

M.D.

www.PRSJour

nal.com

2011 Yes other Consensus opinion

of management of

periprosthetic fluid

diagnosis and

evaluation.

46 Letter to SCHEER

from ASPS

Katie

Sommers

American

Society of

Plastic Surgeons

2016 No other Letter to SCHEER

from Americam

Society of Plastic

Surgeons. 20

papers submitted

not in list


Associated

ALCL:aunique

Entity in the

Spectrum of CD30

Lymphoproliferativ

e Disorders

Katie

Sommers

SARA K. STORY,

MICHAEL K.

SCHOWALTER,

LARISA J.

GESKIN

The

Oncologist

2013 Yes 44 Review of literature

on BIA-ALCL,

17

No Title Contribu

tor


review

ed

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y

desi

gn

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usion criteria

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size

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me

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48 The 2016 revision

of the World

Health

Organization

classification of

lymphoid

neoplasms

Katie

Sommers

Steven H.

Swerdlow, Elias

Campo, Stefano

A. Pileri, Nancy

Lee Harris,

Harald Stein,

Reiner Siebert,

Ranjana Advani,

Michele

Ghielmini, Gilles

A. Salles,

Andrew D.

Zelenetz, and

Elaine S. Jaffe

BLOOD 2016 Yes other New provisional

entity distinguished

from other ALK2

ALCL; noninvasive

disease associated

with excellent

outcome. Also 26.

49 Breast Implant-

Associated

Anaplastic Large

Cell Lymphoma: A

Systematic Review

of the Literature

and Mini-Meta

Analysis

Katie

Sommers

Philip A.

Thompson & H.

Miles Prince

Curr Hematol

Malig Rep

2013 Yes other 49 Review on ALCL

with 49 cases

identified.

50 Literature review

from a patient's

perspective

M.G.J

van

Amersfoo

rt

M.G.J van

Amersfoort

2016 No other Lieterure review on

general aspects of

SBI.

51 Response to

SCHEER request

for information on

breast implant-

associated

anaplastic large

cell lymphoma

(BIA-ALCL)

Peter

Schroeer

2016 Information not

found.

52 Call for

information:

Submission from

PIP Action

Campaign

PIP

Action

Campaig

n

Jan Spivey &

Marie Robinson

2016 No other Provides 20

references for case

repeorts on ALCL.

18

No Title Contribu

tor


review

ed

Stud

y

desi

gn

Cent

er

Inclusion/excl

usion criteria

Sample

size

Outco

me

Comments

53 Anaplastic large

cell lymphoma

(ALCL) and breast

implants:

Breaking down the

evidence

Suzanne

Turner

Xuan Ye ,

Kayvan

Shokrollahi,

Warren M.

Rozen, Rachel

Conyers, Penny

Wright, Lukas

Kenner,

Suzanne D.

Turner, Iain S.

Whitaker

Mutation

Research/Rev

iews in

Mutation

Research

2014 Yes other 71 Review of 71 cases

of BIA_ALCL. The

absolute risk is

considered low

ranging from

1:500,000 to

1:3,000,000

patients with breast

implants per year.

Evaluation of papers received during the call for information · Chenard-Neu, A. M. Tasei, E....

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