evaluation of papers received during the call for information · breast implants pip action campaig...

1

Evaluation of papers received during the call for information

No

Title Aplicant Authors Journal Year Peer reviewe

d

Concerns PIP

Mentions PIP

Comments Study desig

n

Sample size

Comments

1 The continuing saga of silicone gel-filled breast implants in the USA

Arthur E Brawer

Arthur E Brawer none none No No No Not relevant, no peer review. Not published paper.

2 List of chemicals used in the manufacturing process of silicone gel-filled breast implants

Arthur E Brawer

Arthur E Brawer 1990,s

No No No Listing without references

3 IARC Monographs on the evaluation of carcinogenic

risks to humans. Internal report 14/002. Report of the IARC advisory group to recommend priorities for IARC Monograophs during 2015-2019.

Ekaterina

Mirkova

IARC IARC Monographs 2014 No No No Breast implants were

categorized with; medium priority. See also #30.

4 Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) due to silicone implant incompatibility syndrome in three sisters

Jan Cohen

Kappel RM, Cohen Trevaert JW, Pruijn

Clin Exp Rheumatol 2014 Yes No No Not dealing with PIP. General aspects of SBI adverse effects.

5 Two hundreds cases of ASIA syndrome following silicone implants: a comparative study of 30 years and a review of current literature

Jan Cohen

Colaris MJL, De Boer M, Van Der Hulst RR, Cohen Tervaert JW

Immunol Res 2016 Yes No No Not dealing with PIP. General aspects of SBI adverse

effects.

6 Churg-Strauss Syndrome: Singulair or Silicone (or both?)

Jan Cohen

Paula R. David1,4, Amir Dagan MD2, Maartje Colaris MD4, Mintsje de Boer MD5, Jan W. Cohen Tervaert MD5 and Yehuda Shoenfeld MD

IMAJ, Israel Medical Association J

2016 Yes No No Not dealing with PIP. General aspects of SBI adverse effects.

2

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

FRCP MaCR1,3

7 Is explantation of silicone breast implants useful in patients with complaints?

Jan Cohen

Colaris MJL, Van Der Hulst RR, Cohen Tervaert JW

Immunol Res 2016 Yes No Yes Not dealing with PIP. General aspects of SBI adverse effects.

8 Silicone implant incompatibility syndrome (SIIS): A frequent cause of ASIA (Shoenfeld’s syndrome)

Jan Cohen

Cohen Tervaert JW, Kappel RM

Immunol Res 2013 Yes No No Not dealing with PIP. General aspects of SBI adverse effects.

9 Submission report PIP Action

Campaign

Jan Spivey & Marie Robinson

2016 No Yes Yes 441 Overview of literature on

silicones + survey PIP patients

10 Silicone and scleroderma revisited

PIP Action Campaign

M Lidar1,2, N Agmon-Levin2, P Langevitz1,2 and Y Shoenfeld2

SPECIAL ARTICLE, http://lup.sagepub.com, Lupus (2012) 21, 121–127


11 Silicone Gels, Induction of Plasma Cell Tumors, and Genetic Susceptibility in Mice: a Call for Epidemiologic Investigation of Women With Silicone Breast Implants

PIP Action Campaign

Sydney E. Salmon, Robert A. Kyle

Journal of the National Cancer Institute, Vol. 86, No. 14, July 20, 1994

1994 No No No Editorial

12 Silicone implant incompatibility syndrome

(SIIS): A frequent cause of ASIA (Shoenfeld's syndrome)

PIP Action

Campaign

Jan willem Cohen Tervaert,

Rita M Kappel

Immunol Res (2013) 56:293–298

2013 Yes No No Not dealing with PIP.

General aspects of SBI adverse effects.

13 Siloxanes - Consumption, Toxicity and Alternatives

PIP Action Campaign

Carsten Lassen, Charlotte Libak Hansen, Sonja Hagen Mikkelsen & Jakob Maag

Danish Ministry of the Environment, Environmental Protection Agency

2005 No No No Report, governmental agency

3

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

14 Systemic Sclerosis and Silicone Breast Implant: A Case Report and Review of the Literature

PIP Action Campaign

Antonios Psarras, Ioannis Gkougkourelas, Konstantinos Tselios, Alexandros Sarantopoulos, and Panagiota Boura

Hindawi Publishing Corporation, Case Reports in Rheumatology


15 The 2013 Berlaymont Declaration on Endocrine Disrupters

PIP Action Campaign

The 2013 Berlaymont Declaration on Endocrine Disrupters

The 2013 Berlaymont Declaration on Endocrine Disrupters

2013 No No No No peer review, not a study

16 The impact of cosmetic

breast implants on breastfeeding: a systematic review and meta-analysis

PIP

Action Campaign

.Michal Schiff,

Charles S Algert, Amanda Ampt, Mark S Sywak, and Christine L Roberts

Int Breastfeed J. 2014 Yes No No Not dealing

with PIP. General aspects of SBI adverse effects.

17 The Role of Bacterial Biofilms in Device-Associated Infection

PIP Action Campaign

Anand K. Deva, William P. Adams, Karen Vickery,

www.PRSJournal.com 2014 Yes No No Not dealing with PIP. General aspects of SBI adverse effects.

18 The Relationship of Bacterial Biofilms and Capsular Contracture in Breast Implants

PIP Action Campaign

Dragana Ajdic, Yasmina Zoghbi, David Gerth, Zubin J. Panthaki, Seth

Thaller

Aesthetic Surgery Journal

2016 Yes No No Not dealing with PIP. General aspects of SBI adverse

effects.

19 The impacts of endocrine disrupters on wildlife, people and their environments

PIP Action Campaign

European Environment Agency

European Environment Agency

2012 No No No Report, international agency

http://www.prsjournal.com/

4

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

20 Two hundreds cases of ASIA syndrome following silicone implants: a comparative study of 30 years and a review of current literature

PIP Action Campaign

Colaris, M.J.L., de Boer, M., van der Hulst, R.R.

Immunol Res 2016 Yes No No Not dealing with PIP. General aspects of SBI adverse effects.

21 Review of recent advances in research on the toxicity, detection, occurrence and fate of cyclic volatile methyl siloxanes in the environment

PIP Action Campaign

De-Gao Wang, Warren Norwood, Mehran Alaee, Jonathan D. Byer, Samantha Brimble

Chemosphere 93 (2013) 711–725


22 Borstimplantaten veilig? PIP Action Campaign

M.G.J. van Amersfoort

SVS-MKS 2016 No No Yes No peer review (in Dutch), list of references. Describes various aspects of SBI toxicity

23 Endocrine disrupting chemicals 2012

PIP Action Campaign

Åke Bergman, Jerrold J. Heindel, Susan Jobling, Karen A. Kidd, R. Thomas Zoeller

WHO, The Inter-Organisation Programme for the Sound Management of Chemicals (IOMC)


24 Mortality in Swedish women with cosmetic breast implants

PIP Action Campaign

Diana Zuckerman

BMJ 2003 No No No Correspondence

25 Autoimmune/inflammatory syndrome induced by adjuvant (ASIA) evolution after silicone implants. Who is at risk?

PIP Action Campaign

Idan Goren, Gad Segal, Yehuda Shoenfeld

Clin Rheumatol 2015 Yes No No Not dealing with PIP. General aspects of SBI adverse effects.

5

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

26 The 2016 revision of the World Health Organization classification of lymphoid neoplasms

PIP Action Campaign

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

www.bloodjournal.org 2016 Yes No No Not dealing with PIP. General aspects of SBI adverse effects.

27 Hormone-disrupting chemicals: when will the eu act against these everyday toxicants

PIP Action Campaign

Pelle Moos The European Consumer Association

2016 No No No Report, NGO

28 Axillary lipogranuloma mimicking carcinoma metastasis after silicone breast implant rupture: A case report

PIP Action Campaign

A. Ozlem Gundeslioglu, Sibel Hakverdi, Ozlem Erdem, E. Cigdem Ozen, Irfan Inan, Dilek Emlik

Journal of Plastic, Reconstructive & Aesthetic Surgery


29 The Hazardous 100+ List of Chemicals of High Concern

PIP Action Campaign

Mind the store; Safer Chemicals Healthy families

www.saferchemicals.org 2016 No No No Not a study, report, no peer review

30 High-grade Angiosarcoma Associated with Ruptured Breast Implants

PIP Action Campaign

Nicolas Smoll, Ross Farhadieh, Ross Ferguson, Michael Findlay, David Hunter

American Society of Plastic Surgeons: www,PRSgo,com


http://www.sciencedirect.com/science/journal/17486815



6

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

31 IARC Monographs on the evaluation of carcinogenic risks to humans. Internal report 14/002. Report of the IARC advisory group to recommend priorities for IARC Monograophs during 2015-2019.

PIP Action Campaign

IARC IARC Monographs 2014 No No No Report, international agency. Breast implants were categorized with medium priority See also #3

32 Is explantation of silicone breast implants useful in patients with complaints?

PIP Action Campaign

M. de Boer, M. Colaris, • R. R. W. J. van der Hulst, J. W. Cohen Tervaert

Immunol Res 2016 Yes No Yes Not dealing with PIP. General aspects of SBI adverse effects.

33 The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks

PIP Action Campaign

Victoria Martindale, Andre Menache

Journal of the Royal Society of Medicine

2013 Yes Yes Yes other Regulatory, proposals for risk management

34 Chemical and physicochemical properties of the high cohesive silicone gel from Poly Implant Prothèse (PIP) breast prostheses after explantation: A preliminary, comparative analytical investigation

PIP Action Campaign

Giangiacomo Beretta, Matteo Malacco

Journal of Pharmaceutical and Biomedical Analysis

2013 Yes Yes Yes Our results demonstrate that, compared to the virgin McGhan gel, the silicone present the PIP prostheses lacks a significant part of the cross-linking sites

necessary for the high-cohesive properties of the gel, significant amounts of cholesterol have been absorbed from the breast tissue by the

cs Dealing with chemical comnposition of PIP silicone gel and not with PIP health effects.

7

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

silicone material, demonstrating the lack of impermeability of its elastomer shell. Analysis of PIP silicone content.

35 Adjuvant Breast Disease: An Evaluation of 100

Symptomatic Women with Breast Implants or Silicone Fluid Injections

PIP Action

Campaign

Britta Ostermeyer

Shoaib, Bernard M Patten and Dick S Calkins

Keio J Med 1993 Yes No No Not dealing with PIP.


36 Letter on Inaccurate Communications Regarding Risks of Breast Implant-Related Cancer

PIP Action Campaign

Sidney Wolfe JAMA. 2011 No No No Correspondence

37 Letter to the FDA from a Mentor Employee

PIP Action Campaign

former Mentor Employee

2006 No No No Correspondence

38 Lipogranulomatosis and hypersplenism induced by ruptured silicone breast implants

PIP Action Campaign

Amer M. Zeidan and Alison R. Moliterno

www,bloodjournal.org 2016 Yes No No Not dealing with PIP. General aspects of SBI adverse effects.

8

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

39 Mortality among Augmentation Mammoplasty Patients

PIP Action Campaign

Brinton, Louise A.; Lubin, Jay H.; Cay Burich, Mary; Colton, Theodore; Hoover, Robert N.

Epidemiology 2001 Yes No No Not dealing with PIP. General aspects of SBI adverse effects.

40 Classification of the substance Octamethylcyclotetrasiloxane (D4)

PIP Action Campaign

DG ENV, DG Enterprise and Industry, DG SANCO

European Commission 2012 No No No Letter answering question on classification D4.

41 Inhalation Toxicology of Decamethylcyclopentasiloxa

ne (D5) Following a 3-Month Nose-Only Exposure in Fischer 344 Rats

PIP Action

Campaign

Leigh Ann Bums-Naas,

Richard W. Mast, Robert G. Meeks, Peter C. Mann, and Philippe Thevenaz

Toxicological Sciences 1998 Yes No No Not dealing with PIP.


42 Persistent, Bioaccumulative, Toxicants (pbts)

PIP Action Campaign

Science & Environmental Health Netwok

www.SaferChemicals. o r g

2016 No No No Not a study, report, no peer review

43 Proposal for a COUNCIL DECISION on the submission, on behalf of the European Union, of a proposal for the listing of additional chemicals in Annex A, B and/or C to the

Stockholm Convention on Persistent Organic Pollutants

PIP Action Campaign

European Commiussion

EC 2016 No No No Proposal for listing D4 Iin EU regulation.

44 Pregnant or Breast Feeding Mums with PIP implants

PIP Action Campaign

PIP Action Mums

PIP Action Mums 2016 No Yes Yes Survey among implant patients, no peer review

9

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

45 The Role of Bacterial Biofilms in Device-Associated Infection

PIP Action Campaign

Anand K. Deva, William P.

Adams, Karen Vickery,

American Society of Plastic Surgeons: www,PRSgo,com


46 Risk of Connective Tissue Disorders among Breast Implant Patients

PIP Action Campaign

Louise A. Brinton, Lenore M. Buckley, Olga Dvorkina, Jay H. Lubin, Theodore Colton, Mary Cay Murray, Robert N.

Hoover

American Journal of Epidemiology


47 Science and policy on endocrine disrupters must not be mixed: a reply to a “common sense” intervention by toxicology journal editors

PIP Action Campaign

Åke Bergman, Anna-Maria Andersson, Georg Becher, Martin van den Berg, Bruce Blumberg, Poul Bjerregaard, Carl-Gustaf Bornehag, Riana Bornman, Ingvar Brandt, Jayne V Brian, Stephanie C Casey, Paul A Fowler, Heloise Frouin12, Linda

C Giudice, Taisen Iguchi, Ulla Hass15, Susan Jobling10, Anders Juul2, Karen A Kidd16, Andreas Kortenkamp10, Monica Lind9, Olwenn V Martin10, Derek Muir17, Roseline

Environmental health 2013 No No No Commentary, editorial

10

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

Ochieng18, Nicolas Olea19, Leif Norrgren20, Erik Ropstad21, Peter S Ross12, Christina Rudén22, Martin Scheringer23, Niels Erik Skakkebaek2, Olle Söder24, Carlos Sonnenschein25, Ana Soto25, Shanna

Swan26, Jorma Toppari27, Charles R Tyler28, Laura N Vandenberg29, Anne Marie Vinggaard15, Karin Wiberg20 and R Thomas Zoeller30

48 Scleroderma and breast implants

PIP Action Campaign

C. HONG, S.R. SANGLE, J.G. COGHLAN and D.P. D’CRUZ

Q J Med 2015 Yes No No Not dealing with PIP. General aspects of SBI adverse effects.

49 Serum proteins and

paraproteins in women with silicone implants and connective tissue disease: a case–control study

PIP

Action Campaign

Gyorgy Csako,

Rene Costello, Ejaz A Shamim, Terrance P O'Hanlon, Anthony Tran, Daniel J Clauw, H James Williams, and Frederick W Miller

Arthritis Res Ther. 2007 Yes No No Not dealing

with PIP. General aspects of SBI adverse effects.

11

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

50 Données PIP Mise à jour des signalements de matériovigilance

PIP Action Campaign

ANSM 2013 No Yes Yes Report, governmental agency

51 Current Implant Surface Technology: An Examination of Their Nanostructure and Their Influence on Fibroblast Alignment and Biocompatibility

PIP Action Campaign

S. Barr, BSc, E. Hill, PhD, and A. Bayat PhD, MBBS, MRCS

Open Access Journal of Plastic Surgery


52 Environmental Chemistry of Organosiloxanes

PIP Action

Campaign

Christoph Rucker* and

Klaus Kummerer

Chemical News 2014 Yes No No Not dealing with PIP.


53 Chronic silicone embolism syndrome due to PIP breast implant leakage – a new entity?

PIP Action Campaign

Dr Preethi Parvathi Gopinath, Dr Ahsan Ali, Mr Filip Van Tornout, Dr Ajay Kamath, Dr Michael Crawford, Professor Andrew G Nicholson

2015 Yes Yes Yes The diagnosis of a chronic pulmonary disease related to silicone leakage from a PIP implant is an important one for patients awaiting explantation or those being

monitored for implant-related symptoms.

cs Shows silicone migration to lung. Case report.

12

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

54 Where the PIP is the implant?

PIP Action Campaign

Moira H.D. Bruintjes a, Corinne Schouten, Jan Fabre´, Frits J. van den Wildenberg, David S. Wijnberg

JPRAS 2014 Yes Yes Yes In case of pleural laceration, appropriate repair should be performed to avoid a communicating space between the implant capsule and pleural cavity. Despite the presence of an implant in

the thorax, the patient did not experience any medical complaints resulting in a substantial delay. However, she did consult the plastic surgeon due to loss of projection of the right breast. Ultrasound confirmed

implant rupture, but gave absolutely no indication of any implant dislocation into the chest cavity e misleading diagnostics galore.

cs Case report on implant rupture

13

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

55 Inflammatory changes of the nipple areolar complex of a patient with PIP breast implants: A possible immune response to free silicone from gel bleed?

PIP Action Campaign

T. Tickunas, S. Howarth, Y. Godwin

Correspondance and communications

2014 Yes Yes Yes Unlike medical grade silicone, PIP implants gel has increased levels of siloxanes. Siloxanes do not cause skin irritation. Hence, the NAC dermatitis may not be a reaction to a specific PIP

gel component but related instead to prolonged exposure of tissues to free liquid silicone.

cs Dealing with chemical composition of PIP silicone gel and not with PIP health effects.

56 Breast implant-associated anaplastic large cell lymphomas

PIP Action Campaign

? French National Cancer Institute

No No No Report, governmental agency

57 Analytical investigations on elastomeric shells of new Poly Implant Prothèse (PIP) breast and from sixteen cases of surgical explantation

PIP Action Campaign

Giangiacomo Berettaa, Sara Panseri, Alessandra Manzo, Rufaida Hamid, Adrian Richards, Matteo Malacco

Journal of Pharmaceutical and Biomedical Analysis

2014 Yes Yes Yes From 2007, the PIP company used a polymerisation process different from that declared, probably as a consequence of the first reports of rupture problems. In addition, the HS-GC-MS experiments demonstrated that at body temperature

obs 24 Dealing with chemical comnposition of PIP silicone gel and not with PIP health effects.

14

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

the diffusivity of low molecular weight (LMW) silicones present in the PIP filler silicone is significantly higher than that of LMW silicones in an approved implant.

58 Anaplastic large cell lymphoma (ALCL) and breast implants: Breaking down the evidence

PIP Action Campaign

Xuan Ye, Kayvan Shokrollahi, Warren M. Rozen, Rachel Conyers, Penny Wright, Lukas Kenner, Suzanne D. Turner, Iain S. Whitaker

Mutation Research/Reviews in Mutation Research

2014 Yes No No Not dealing with PIP. General aspects of SBI adverse effects and ALCL.

59 Anaplastic Large Cell Lymphoma Occurring in Women with Breast Implants: Analysis of 173 Cases

PIP Action Campaign

Garry S. Brody, M.D., M.Sc., Dennis Deapen, Dr.Ph. Clive R. Taylor, 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.

www.PRSJournal.com 2014 Yes No Yes Overview on relation SBI and ALCL

15

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

60 Breast implant (PIP), chronic inflammation and cancer: is there a connection?

PIP Action Campaign

A. Gubitosi, G. Docimo, R. Ruggiero, A. Esposito, E. Esposito, F. Foroni

Annali Italiani Di Chirurgia

2012 Yes Yes Yes The findings of foreign material in granulomas and macrophages that are the primary inflammation body defense, suggest that the chronic inflammation, coming from mammary implants

subject to leakage or/and osmotic shift, increase the risk of breast cancer.

cs Shows chronic inflammation after PIP implant and discusses implant and candcer.

61 Rupture of Poly Implant Prothèse (PIP) Silicone Breast Implants: An Implant

PIP Action Campaign

Eric Swarts, BSc Alan M Kop, PhD Anastasia Nilasaroya, PhD Catherine V Keogh, DipAppSci Timothy Cooper, FRACS

Plastic and Reconstructive Surgery Advance Online Article

2013 Yes Yes Yes The high incidence of Poly Implant Prothèse shell rupture is most likely a result of inadequate quality control, with contributory factors being shell thickness variation and manufacturing defects on both inner and outer surfaces of the shell. No evidence of shell degradation with

obs 27 Evaluates shell quality of PIP ruptured implants

16

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

implantation time was determined.

62 Bacterial Biofilm Infection Detected in Breast Implant–Associated Anaplastic Large Cell Lymphoma

PIP Action Campaign

Honghua Hu, Ph.D.; Khalid Johani; Ahmad Almatroudi; Karen Vickery, Ph.D., B.V.Sc.; Bruce Van Natta, M.D.; Marshall E. Kadin, M.D.; Garry Brody, M.D.; Mark

Clemens, M.D.; Chan Yoon Cheah, M.D.; Stephen Lade, M.D.; Preeti Avinash Joshi, M.D., Ph.D.; H. Miles Prince, M.D., Ph.D.; Anand K. Deva, B.Sc.(Med.), M.B.B.S., M.S.

Plastic and Reconstructive Surgery


63 Rebuttal and Critical Review of Andersen et al.'s D4 PBPK Model

PIP Action Campaign

Hoan-My Do Luu, Joseph C. Hutter

Environmental Health Perspectives

2002 No No No Not dealing with PIP.

17

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

64 Biomarkers Provide Clues to Early Events in the Pathogenesis of Breast Implant-Associated Anaplastic Large Cell Lymphoma

PIP Action Campaign

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;William P. Adams Jr.,MD; Garry S. Brody,MD; and Alan L.

Epstein,MD, PhD

Aesthetic Surgery Journal

2016 Yes No No Not dealing with PIP. Relation between biomarkers and SBI related ALCL.

65 Bcuk info sheet /in-utero exposures

PIP Action Campaign

Fact sheet Breast Cancer UK No No No Fact sheet, charity

66 Pathology of silicone leakage from breast implants

PIP Action Campaign

Paul J van Diest,Werner H Beekman, Joris J Hage

Jounral of Clinical Pathology


67 Breast Implants and Cancer PIP Action

Campaign

Louise A. Brinton, S. Lori

Brown

Journal of the National Cancer Institute



68 Capsular contracture e What are the risk factors? A 14 year series of 1400 consecutive augmentations

PIP Action Campaign

Anne Dancey, Abdul Nassimizadeh, Paul Levick



18

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

69 Chemical Contaminants in Breast Milk and Their Impacts on Children’s Health: An Overview

PIP Action Campaign

Philip J. Landrigan,1 Babasaheb Sonawane,2 Donald Mattison,3 Michael McCally,1 and Anjali Garg1

Environmental Health Perspectives

2002 Yes No No Not dealing with PIP. Deals with chemical contaminants in breast milk.

70 Chronic Biofilm Infection in Breast Implants Is Associated with an Increased T-Cell Lymphocytic Infiltrate: Implications for Breast

Implant–Associated Lymphoma

PIP Action Campaign

Dennis C. Hammond, M.D.

Plastic and Reconstructive Surgery


71 Gel Bleed and Rupture of Silicone Breast Implants Investigated by Light-, Electron Microscopy and Energy Dispersive X-ray Analysis of Internal Organs and Nervous Tissue

PIP Action Campaign

R.M. Kappel, L.L. Boer and H. Dijkman

Clinical Medical Reviews and Case Reports


72 Complete Surgical Excision Is Essential for the Management of Patients With Breast Implant–Associated Anaplastic Large-Cell Lymphoma

PIP Action Campaign

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.

JOURNAL OF CLINICAL ONCOLOGY

2016 Yes No No Not dealing with PIP.Deals with ALCL

19

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

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. Miranda

73 The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks

PIP Action Campaign

Victoria Martindale, Andre Menache

Journal of the Royal Society of Medicine

2013 Yes Yes Yes other Regulatory, proposals for risk management

74 Cutaneous manifestation of silicone dissemination from a PIP implant - a case for prophylactic explantation?

PIP Action Campaign

N.H. Cawrse*, M.A. Pickford


2011 Yes Yes Yes Gel bleed from high cohesive gel implants with

similar effect is also well known. However dissemination to sites distant from the breast manifest as cutaneous abnormalities in a patient implanted

cs Case report on gel bleed and migration.

20

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

with a PIP product raises concern.

75 Cyclic volatile methylsiloxanes in human blood as markers for

ruptured silicone gel-filled breast implants

PIP Action Campaig

n

Pia Rosendahl & Joerg Hippler & Oliver J.

Schmitz & Oliver Hoffmann & Peter Rusch

Anal Bioanal Chem 2016 Yes No Yes other 24 Blood test for diagnosing silicon breast

implant rupture. Not dealing with PIP. See also no 87.

76 Breast Implants, Self-Esteem, Quality of Life, and the Risk of Suicide

PIP Action Campaign

Diana M. Zuckerman, PhD, Caitlin E. Kennedy, PhD, Mishka Terplan, MD, MPH

Women's Health Issues 2016 Yes No No Not dealing with PIP.

77 Summary of Classification and Labelling

PIP Action Campaig

n

ECHA Classification - CL inventory


Report, international agency

78 The non-specific symptoms of breast implant-associated anaplastic large cell lymphoma resulting in delayed diagnosis: A case-based review

PIP Action Campaign

Reem Dina Jarjis*, Lone Bak Hansen, Steen Henrik Matzen

JPRAS Open 2015 Yes No No Not dealing with PIP. SBI and ALCL.

21

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

79 MRI findings of breast silicone implants, including unusual signs of rupture and extravasation of the silicone gel. A pictorial essay

PIP Action Campaign

M. H. Siqueira Mendonça, S. Nagae, V. Merjane, F. Finguerman Dwek, D. S. Silva, L. Yamashita

European Society of Radiology

2013 Yes No Yes obs Not dealing with PIP. MRI of breast implants for rupture diagnosis.

80 Endocrine Disruptors and Impact on Health

PIP Action Campaign

? European Parliament - DG for Internal Policies workshop - endocrine disruptors and impact on health


81 Plasma concentrations of cyclic volatile methylsiloxanes (cvms) in pregnant and postmenopausal Norwegian women and self-reported use of personal care products (pcps)

PIP Action Campaign

Linda Hanssen, Nicholas A. Warner, Tonje Braathen, Jon Ø. Odland, Eiliv Lund, Evert Nieboer a,c, Torkjel M. Sandanger

Environment International

2013 Yes No No Not dealing with PIP. Deals with siloxanes exposure after exposure to personal care products.

22

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

82 Exposure of pregnant consumers to suspected endocrine disruptors

PIP Action Campaign

Dorthe Nørgaard Andersen, Lise Møller and Helle Buchardt Boyd, DHI Julie Boberg, Marta Axelstad Petersen, Sofie Christiansen and Ulla Hass, Food DTU Pia Brunn Poulsen, Maria Strandesen and Daniela Bach,

FORCE Technology

The Danish Environmental Protection Agency


83 Conforming to State of the Art Requirements for CE Marking

PIP Action Campaign

Keith Morel SCIENCE & TECHNOLOGY

2010 No No No Not dealing with PIP. Not a scientific study.

84 Findings from examination of elastomeric shell(s) from poly implant prothèse intact explanted implants

PIP Action Campaign

Dr Giangiacomo Beretta

Universita degli Studi de Milano

No Yes Yes Not a study, no peer review, lab analysis of explant

85 Silicone Gel Bleed on Breast Implants

PIP Action Campaign

Felipe Rebello Lourenço, Irene Satiko Kikuchi and Terezinha de Jesus Andreoli Pinto

The Open Biomaterials Journal


86 Real world evidence PIP Action Campaign

PIP Action Campaign

PIP Action Campaign - Responding to European Commission’s SCHEER Committee Call for Information

2016 No No No Report, NGO. Not dealing with PIP.

23

No


d

Concerns PIP

Mentions PIP


n

Sample size

Comments

87 Cyclic volatile methylsiloxanes in human blood as markers for ruptured silicone gel-filled breast implants

Oliver Schmitz

Pia Rosendahl & Joerg Hippler & Oliver J. Schmitz & Oliver Hoffmann & Peter Rusch

Analytical and Bioanalytical Chemistry

2016 Yes No Yes other 24 Not dealing wit PIP.Blood test for diagnosing silicon breast implant rupture. See also no 75.

evaluation of papers received during the call for information · breast implants pip action campaig...

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