Expert Rev Med Devices. 2013 Mar;10(2):167-70. doi: 10.1586/erd.12.87.

Complications of Poly Implant Prothse breast implants:

the current discussion.
Kolios L, Hirche C, Spiethoff A, Daigeler A, Lehnhardt M.
Department of Hand, Plastic and Reconstructive Surgery, Burn Care Unit, University of Heidelberg,
BG Trauma Center Ludwigshafen, Ludwig-Guttmann-Strasse 13, 67071 Ludwigshafen, Germany.
http://www.ncbi.nlm.nih.gov/pubmed/23480085
AgalnsL Lhe background of Lhe currenL dlscusslon abouL oly lmplanL roLhese (l, Seyne-
sur-mer, lrance) breasL lmplanLs, we wanL Lo presenL a case demonsLraung Lhe
compllcauons such as lmplanL rupLure, slllcone dlssemlnauon and level lll slllcone
lymphadenopaLhy. A 29-year-old woman wlLh cosmeuc breasL augmenLauon wlLh l
lmplanLs 3 years prevlously showed a sensluve swelllng ln her rlghL axllla and neck reglon.
All LesLs Lo deLecL an lnfecuous or lymphomaLous lymphadenopaLhy were negauve. Aer
ulLrasound and M8l, rupLure of Lhe rlghL lmplanL was assumed and muluple paLhologlcally
enlarged lymph nodes up Lo supraclavlcular reglon were shown. An exclslon blopsy of one
axlllary lymph node was performed, Lhe hlsLologlcal examlnauon deLecLed a sLrong slllcone
lymphadenopaLhy. Surglcal removal of boLh lmplanLs as well as capsulecLomy was
performed and 14 axlllary lymph nodes up Lo level ll were resecLed. PlsLologlc evaluauon
conrmed Lhe prevlous resulLs. Cur case under||nes the actua| d|scuss|on concern|ng
|ncreased rupture rate and mass|ve s|||cone |ymphadenopathy by I |mp|ants.
ub||shed C||n|ca| Stud|es 1
SLudles 8eferenced ln correspondence wlLh Slr 8ruce keogh l AC1lCn CAMAlCn
Surgeon. 2013 Mar 14. pii: S1479-666X(13)00017-6. doi: 10.1016/j.surge.2013.02.006. [Epub
ahead of print]
Poly Implant Prothse (PIP) breast implants: Our experience.
Chummun S, McLean NR.
Source
ueparLmenL of lasuc Surgery, lrenchay PosplLal, lrenchay ark 8oad, 8rlsLol 8S16 1LL, uk. LlecLronlc
address: shaheelchummun[hoLmall.com.
hup://www.ncbl.nlm.nlh.gov/pubmed/23499229
Abstract
ln18CuuC1lCn:
1hls sLudy descrlbes our experlence on Lhe managemenL of pauenLs wlLh l (oly lmplanL
roLhese) breasL lmplanLs beLween 2000 and 2008.
MA1LkIALS AND ML1nCDS:
1he medlcal records of pauenLs were revlewed. uaLa was collecLed on cllnlcal presenLauon,
lnvesugauons, managemenL and ouLcome.
kLSUL1S:
44 pauenLs, wlLh bllaLeral breasL lmplanLs, and a medlan age of 33 years (18-34 years),
were revlewed, and of Lhese, 31 pauenLs were asympLomauc. SympLoms aL presenLauon
lncluded lymphadenopaLhy, capsule formauon, breasL lump, seroma and breasL paln.
auenLs underwenL mammography, ulLrasound and M8l scannlng of Lhe breasLs as parL of
Lhe lmaglng lnvesugauons. 3 pauenLs decllned explanLauon. 8easons for explanLauon
lncluded pauenL anxleLy, sllenL rupLure, aesLheuc breasL change, palpable nodes and breasL
lump. 17 ouL of a LoLal of 78 lmplanLs (21.8) were noLed Lo have rupLured, 2 had a slmple
Lear and 13 were LoLally dlslnLegraLed. 1 pauenL underwenL removal of Lhe lmplanLs, 18
underwenL exchange of lmplanLs, and 20 pauenLs had a capsuloLomy and exchange of
lmplanLs. osLoperauve compllcauons lncluded wound lnfecuon, seroma, axlllary
lymphadenopaLhy, hypersensluve scar and overgranulauon of Lhe wound.
CCNCLUSICN:
Cur serles conrms Lhe hlgh raLe of l lmplanL rupLure (21.8), Lhe ma[orlLy of whlch
were asympLomauc. 1he maln reasons for explanLauon were pauenL anxleLy and sllenL
rupLure of lmplanLs. It |s |mperanve that panents shou|d be appropr|ate|y counse|ed,
pr|or to surgery w|th regards to remova| of the |mp|ants, g|ven the |ncreased rupture
rates noted.
CopyrlghL 2013 8oyal College of Surgeons of Ldlnburgh (Scomsh charlLy number SC003317) and 8oyal
College of Surgeons ln lreland. ubllshed by Llsevler LLd. All rlghLs reserved.
ub||shed C||n|ca| Stud|es 2
SLudles 8eferenced ln correspondence wlLh Slr 8ruce keogh l AC1lCn CAMAlCn
J Plast Reconstr Aesthet Surg. 2013 Feb;66(2):267-9. doi: 10.1016/j.bjps.2012.06.018. Epub 2012
Jul 25.
Bilateral supraclavicular swelling: an unusual presentation of
ruptured Poly Implant Prosthese (PIP) breast implants.
Manickavasagar T, Morritt AN, Offer GJ.
The Department of Plastic Surgery, Leicester Royal Infirmary, Leicester LE1 5WW, UK.
t.manickavasagar@doctors.org.uk
http://www.ncbi.nlm.nih.gov/pubmed/22836112
Abstract
8reasL lmplanLs manufacLured by Lhe lrench company oly lmplanL rosLhese (l) have
galned noLorleLy ln Lhe lnLernauonal medla slnce Lhe reallsauon LhaL lndusLrlal grade
slllcone was used ln Lhelr manufacLure wlLh consequenL lncreased rlsk of lmplanL rupLure.
AL presenL, lL ls esumaLed LhaL Lhere are esumaLed Lo be over 40,000 women ln Lhe uk
wlLh l lmplanLs. We report an unusua| presentanon of I breast |mp|ant rupture as
swe|||ng |n the suprac|av|cu|ar fossae. 1h|s has not prev|ous|y been reported |n the
||terature.
CopyrlghL 2012 8rlush Assoclauon of lasuc, 8econsLrucuve and AesLheuc Surgeons. ubllshed by
Llsevler LLd. All rlghLs reserved.
ub||shed C||n|ca| Stud|es 3
SLudles 8eferenced ln correspondence wlLh Slr 8ruce keogh l AC1lCn CAMAlCn
Ann Ital Chir. 2012 Sep 28;83. pii: S2239253X12019883.
Breast implant (PIP), chronic inflammation and cancer: is there
a connection? Case report.
Gubitosi A, Docimo G, Ruggiero R, Esposito A, Esposito E, Foroni F.
hup://www.ncbl.nlm.nlh.gov/pubmed/23073481
Abstract
1he "l problem", ln Lhe eld of Lhe breasL augmenLauon, represenLs Loday a surglcal
epldemlologlcal emergency. 1he masslve medla coverage produced a klnd of mass fear and
many women are asklng for explanLauons. A 47 y.o. female, breasLs lmplanLed wlLh l
devlces for breasL augmenLauon ln 1998, came Lo our cllnlc asklng for explanLauon and
exclslonal blopsy of a 2.3 cm nodule ad[acenL Lo Lhe upper slde of Lhe breasL lmplanL
capsule. 1he ouLcome of Lhe paLhologlc examlnauon of Lhe exclsed nodule was: ducLal
lnlLraung carclnoma of Lhe breasL, medlum degree of dlerenuauon. Aer 7 days from
Lhe rsL operauon Lhe pauenL underwenL a skln-sparlng masLecLomy wlLh axlllary
lymphadenecLomy and lmmedlaLe reconsLrucuon by a submuscular placemenL of lmplanL.
1he surg|ca| spec|men sent for patho|og|c exam|nanon revea|ed: "granu|omatous
|nammanon by g|ant ce||s around extraneous mater|a|, |ymph nodes, neganve for
cancer, showed extens|ve accumu|anon of foamy macrofages conta|n|ng extraneous
mater|a|". 1he hnd|ngs of fore|gn mater|a| |n granu|omas and macrophages that are the
pr|mary |nammanon body defense, suggest that the chron|c |nammanon, com|ng from
mammary |mp|ants sub[ect to |eakage or]and osmonc sh|h, |ncrease the r|sk of breast
cancer. We therefore suggest |mprov|ng the exp|antanon]rep|acement of o|d |mp|ants.
kL? WC8uS: 8reasL cancer, LxLraneous maLerlal, lmmedlaLe breasL reconsLrucuon, lnammauon, lp
lmplanL.
ub||shed C||n|ca| Stud|es 4
SLudles 8eferenced ln correspondence wlLh Slr 8ruce keogh l AC1lCn CAMAlCn
Aesthetic Plast Surg. 2013 Feb;37(1):91-4. doi: 10.1007/s00266-012-0015-y. Epub 2013 Jan 4.
Ruptured poly-implant protheses breast implant after aesthetic
breast augmentation: diagnosis, case management, and
histologic evaluation.
Dieterich M, Stubert J, Stachs A, Radke A, Reimer T, Gerber B.
8reasL unlL, ueparLmenL of CbsLeLrlcs and Cynecology, unlverslLy of 8osLock, Suedrlng 81, 18039, 8osLock,
Cermany. max.dleLerlch[unl-rosLock.de
hup://www.ncbl.nlm.nlh.gov/pubmed/23288097
Abstract
Slnce Lhe scandal of Lhe poly-lmplanL proLheses (l) breasL lmplanLs, all pauenLs wlLh l
are advlsed Lo have Lhelr lmplanLs removed. WlLh approxlmaLely 400,000 l lmplanLs sold
worldwlde breasL, surgeons wlll be confronLed wlLh Lhese pauenLs. n|sto|og|c exam|nanon
|n the reported case showed s|||cone |nh|tranon |nto fauy nssue and breast nssue
w|thout s|gns of ma||gnancy. A general hlsLologlc analysls for Lhe rare evenL of an
anaplasuc large 1 cell lymphoma ls noL advlsed. 1he mallgnanL poLenual of l lmplanLs
currenLly ls uncerLaln, and further |nvesnganon |s requ|red.
Level of Lvldence v 1hls [ournal requlres LhaL auLhors asslgn a level of evldence Lo each arucle. lor a full
descrlpuon of Lhese Lvldence-8ased Medlclne raungs, please refer Lo Lhe 1able of ConLenLs or Lhe onllne
lnsLrucuons Lo AuLhors www.sprlnger.com/00266 .
ub||shed C||n|ca| Stud|es S
SLudles 8eferenced ln correspondence wlLh Slr 8ruce keogh l AC1lCn CAMAlCn
Aesthetic Plast Surg. 2013 Apr;37(2):278-89. doi: 10.1007/s00266-012-0025-9. Epub 2013 Jan 26.
Silicone lymphadenopathy after breast augmentation: case
reports, review of the literature, and current thoughts.
Zambacos GJ, Molnar C, Mandrekas AD.
Aruon lasuc Surgery CenLer, ALhens, Creece, gz[aesLheucsurgery.gr.
Abstract
8ACkC8Cunu:
Slllcone lymphadenopaLhy aer lmplanLauon of slllcone breasL lmplanLs ls a forelgn body
reacuon due Lo Lhe release or mlgrauon of slllcone lnLo Lhe ussues surroundlng Lhe breasL
lmplanL.
ML1nCDS:
lor Lhe sLudy, 14 cases of slllcone lymphadenopaLhy were ldenued from Lhe auLhors' les.
lour pauenLs had been lmplanLed before 2000 and had varlous Lypes of lmplanLs. 1he
remalnlng 10 pauenLs all were lmplanLed beLween 2006 and 2009, and all had oly lmplanL
roLhese (l) lmplanLs. ln addluon Lo an analysls of Lhe auLhors' own cases, a Lhorough
blbllographlc search was lnluaLed Lo ldenufy all reporLs of lymphadenopaLhy relaLed Lo
slllcone breasL lmplanLs.
kLSUL1S:
1he lmplanL age of Lhe four pauenLs lmplanLed before 2000 was 12-34 years (mean,
17.23 years). 1he lmplanL age of Lhe 10 pauenLs lmplanLed aer 2000 was 2-6 years (mean
3.43 years). 1he llLeraLure search ldenued 29 papers wlLh case reporLs of slllcone
lymphadenopaLhy publlshed beLween 1978 and 2012, wlLh a LoLal of 173 cases. usable
daLa were exLracLed from 164 of Lhe 173 cases. Cf Lhese pauenLs, 139 were lmplanLed
before (and lncludlng) Lhe year 2000 and had a mean age of 11 years aL presenLauon or
explanLauon, and 3 of Lhese pauenLs were lmplanLed aer Lhe year 2000 and had a mean
age of 4.6 years aL presenLauon or explanLauon . Aer lncluslon of Lhe auLhors' own cases,
Lhe mean age of Lhe lmplanLs aL presenLauon or explanLauon was 10.36 years ln a LoLal of
178 cases. Cf Lhese pauenLs, 163 were lmplanLed before (and lncludlng) Lhe year 2000 and
had a mean age of 11.16 years aL presenLauon or explanLauon, and 13 of Lhese pauenLs
were lmplanLed aer Lhe year 2000 and had a mean age of 4.06 years aL presenLauon or
explanLauon.
CCNCLUSICNS:
CurrenL breasL lmplanL Lechnology has mlnlmlzed Lhe release of slllcone gel due Lo rupLure
or bleedlng of slllcone and lLs mlgrauon lnLo Lhe surroundlng ussues, Lhus reduclng Lhe raLe
of slllcone lymphadenopaLhy ln Lhe lasL 10 years. 1he I |mp|ant scanda| h|gh||ghts the
fact that d|sregard for the |mp|ant manufactur|ng techno|og|es and standards |n favor of
h|gher prohts |ncreased rupture rates and ge| d|us|on, |ead|ng to |ncreased |oca|
comp||canon rates. Slllcone lymphadenopaLhy ls a forelgn body reacuon LhaL does noL
warranL LreaLmenL unless lL ls sympLomauc or lnLerferes wlLh breasL cancer deLecuon.
LLvLL Cl LvluLnCL lll: 1hls [ournal requlres LhaL auLhors asslgn a level of evldence Lo each arucle. lor a full
descrlpuon of Lhese Lvldence-8ased Medlclne raungs, please refer Lo Lhe 1able of ConLenLs or Lhe onllne
lnsLrucuons Lo AuLhors www.sprlnger.com/00266 .
ub||shed C||n|ca| Stud|es 6
SLudles 8eferenced ln correspondence wlLh Slr 8ruce keogh l AC1lCn CAMAlCn
J Pharm Biomed Anal. 2013 May 5;78-79:75-82. doi: 10.1016/j.jpba.2013.01.040. Epub 2013 Feb
10.
Chemical and physicochemical properties of the high cohesive
silicone gel from Poly Implant Prothse (PIP) breast
prostheses after explantation: A preliminary, comparative
analytical investigation.
Beretta G, Malacco M.
ueparLmenL of harmaceuucal Sclences, laculLy of harmacy, unlverslLy of Mllan, vla Manglagalll 23,
20133 Mllan, lLaly. LlecLronlc address: glanglacomo.bereua[unlml.lL.
hup://www.ncbl.nlm.nlh.gov/pubmed/23434600
AbsLracL
Alm of Lhls work was Lo galn a deeper lnslghL lnLo Lhe analyucal prole of Lhe
macromolecular and LMW fracuons of polymerlc slllcones presenL ln breasL lmplanLs. 1he
sLudy was conducLed on slllcone gel samples from (l) breasL prosLheses (oly lmplanL
roLhese, l) explanLed from a pauenL LhaL needed Lhelr Lherapeuucal removal, (ll) from a
vlrgln Mc Chan 410 Mx prosLhesls and (lll) from a sample of Lechnlcal-grade non-coheslve
slllcone. 1he gels were analysed uslng rheologlcal Lechnlques, auenuaLed LoLal reecLance
lnfrared specLroscopy (A18-l1-l8), nuclear magneuc resonance ((1)P nM8), gas
chromaLography coupled Lo mass specLromeLry (CC-MS) and ow ln[ecuon elecLrospray
mass specLromeLry (ll-LSl-MS). Cur resu|ts demonstrate that, compared to the v|rg|n
McGhan ge|, the s|||cone present the I prostheses |acks a s|gn|hcant part of the cross-
||nk|ng s|tes necessary for the h|gh-cohes|ve propernes of the ge|, s|gn|hcant amounts of
cho|estero| have been absorbed from the breast nssue by the s|||cone mater|a|,
demonstranng the |ack of |mpermeab|||ty of |ts e|astomer she||. 1he poLenual
lmpllcauons and consequences of Lhese analyucal resulLs are dlscussed.
CopyrlghL 2013 Llsevler 8.v. All rlghLs reserved.
ub||shed C||n|ca| Stud|es 7
SLudles 8eferenced ln correspondence wlLh Slr 8ruce keogh l AC1lCn CAMAlCn
Ann Chir Plast Esthet. 2012 Dec;57(6):558-66. doi: 10.1016/j.anplas.2012.04.007. Epub 2012 May
29.
[Breast augmentation by Poly Implant Prothses silicone
implants: retrospective study about 99 patients. Rupture
analysis and management].
[Article in French]
Aktouf A, Auquit-Auckbur I, Coquerel-Beghin D, Delpierre V, Milliez PY.
Servlce de chlrurgle plasuque, reconsLrucLrlce eL esLheuque, SCS malns, CPu Charles-nlcolle, 8ouen,
lrance. ghanlakLouf[hoLmall.com
hup://www.ncbl.nlm.nlh.gov/pubmed/22631997
Abstract
8ACkC8Cunu:
8reasL augmenLauon ls one of Lhe mosL frequenL lnLervenuon ln plasuc surgery. ln March
2010, Lhe Afssaps has wlLhdrawn from Lhe markeL all Lhe oly lmplanL roLheses (l)
slllcone lmplanLs, Lhe auLhors reporL a reLrospecuve sLudy of 99 pauenLs who had breasL
augmenLauon by l lmplanLs. 1he alms of Lhls work are Lo evaluaLe Lhe rupLures observed
wlLh Lhese lmplanLs and Lo propose a managemenL.
ML1nCDS:
We lncluded ln Lhe sLudy 99 pauenLs and 192 slllcone gel lmplanLs. 1he lnLervenuons were
performed beLween 2003 and 2010. Cn 192 lmplanLs, 184 had a LexLured surface and elghL
a smooLh one. Accordlng Lo Lhe laLesL recommendauons from Lhe Afssaps, all pauenLs had
a cllnlcal examlnauon and an ulLrasonography looklng for rupLure slgns. M8l was
performed ln case of doubL.
kLSUL1S:
We found 23 ruptured |mp|ants: 18 |ntracapsu|ar and hve extracapsu|ar ruptures,
|nvo|v|ng 17 panents. We a|so found 28 panents w|th ax|||ary |ymphadenopathy and
e|ght panents w|th |ocoreg|ona| s|||cone spread. I|na||y, we found that 3S panents had
chron|c breast pa|ns.
CCNCLUSICN:
G|ven our resu|ts, |t seems reasonab|e to w|thdraw a|| the I s|||cone breast |mp|ants.
CopyrlghL 2012 Llsevler Masson SAS. All rlghLs reserved.
ub||shed C||n|ca| Stud|es 8
SLudles 8eferenced ln correspondence wlLh Slr 8ruce keogh l AC1lCn CAMAlCn
Br J Surg. 2013 Mar 8. doi: 10.1002/bjs.9094. [Epub ahead of print]
Surface and mechanical analysis of explanted Poly Implant
Prosthse silicone breast implants.
Yildirimer L, Seifalian AM, Butler PE.
ueparLmenL of lasuc and 8econsLrucuve Surgery, 8oyal lree PosplLal PampsLead nPS 1rusL, and unlverslLy
College London (uCL) CenLre for nanoLechnology and 8egenerauve Medlclne, uCL ulvlslon of Surgery and
lnLervenuonal Sclence, uCL, London, uk.
hup://www.ncbl.nlm.nlh.gov/pubmed/23473661
Abstract
8ACkC8Cunu:
1he recenL evenLs surroundlng oly lmplanL rosLhese (l) breasL lmplanLs have renewed
Lhe debaLe abouL Lhe safeLy prole of slllcone lmplanLs. 1he lnLenuonal use of lndusLrlal-
grade lnsLead of cerued medlcal-grade slllcone ls LhoughL Lo be responslble for reporLedly
hlgher frequencles of lmplanL rupLure ln vlvo. 1he dlerences ln mechanlcal and
vlscoelasuc properues beLween l and medlcal-grade slllcone lmplanL shells were
lnvesugaLed. Surface characLerlzauon of shells and gels was carrled ouL Lo deLermlne
sLrucLural changes occurrlng aer lmplanLauon.
ML1nCDS:
8reasL lmplanLs were obLalned from women aL Lhe 8oyal lree PosplLal (London, uk). l
lmplanLs were compared wlLh medlcal-grade conLrol slllcone lmplanLs. 1enslle sLrengLh,
Lear reslsLance and elongauon aL break were assessed uslng a Lenslle LesLer. Surfaces were
analysed uslng auenuaLed LoLal reecLance-lourler Lransform lnfrared (A18-l1l8)
specLroscopy. Spearman correlauon analyses and kruskal-Wallls one-way sLausucal LesLs
were performed for mechanlcal daLa.
kLSUL1S:
1here were 18 l and four medlcal-grade slllcone lmplanLs. l slllcone shells had
slgnlcanLly weaker mechanlcal sLrengLh Lhan conLrol shells ( < 0009). 1here were
negauve correlauons beLween mechanlcal properues of l shells and lmplanLauon umes,
lndlcauve of deLerlorauon of l shells over ume ln vlvo (rs = -073, = 0009 for Lenslle
sLrengLh, rs = -076, = 0001 for maxlmal sLraln). Compar|son of A1k-I1Ik spectra of I
and contro| s|||cones demonstrated changes |n mater|a| character|sncs dur|ng the per|od
of |mp|antanon suggesnve of nme-dependent bond breakage and degradanon of the
mater|a|.
CCNCLUSICN:
1h|s study demonstrated an |ncreased weakness of I she||s w|th nme and therefore
supports the argument for prophy|acnc remova| of I breast |mp|ants.
2013 8rlush !ournal of Surgery SocleLy LLd. ubllshed by !ohn Wlley & Sons, LLd.
ub||shed C||n|ca| Stud|es 9
SLudles 8eferenced ln correspondence wlLh Slr 8ruce keogh l AC1lCn CAMAlCn