Loia mo Manunu’a mai le Upega o le Fatafata Fa’alētonu, Acellular Dermal Matrix, ma le Bioabsorbable Scaffold i Amerika Samoa: O le Ta’iala A’ia’i mo Fafine, Aiga, ma Tagata na A’afia

Mo fafine i Amerika Samoa o ē na faia ni ta’otoga e toe fa’aleleia ai le fatafata, fa’amatagofie, pe toe sui ai se ta’otoga muamua, o le ala i le fa’amalologa e masani lava ona fa’ailogaina i le malosi ma le onosa’i. Peita’i, mo le to’atele i lo tatou nu’u, o lenā ala ua punitia ona o le lē taulau o mea fa’afoma’i na fa’aaogaina i ta’otoga—aemaise lava le acellular dermal matrix (ADM), bioabsorbable scaffolds pei o le GalaFLEX, ma mea fa’apipi’i e taaligoligo (textured implants)—ia na fa’asalalauina e saogalemu ae talu mai lenā taimi ua feso’ota’i atu i ni fa’afitauli tuga. Pe na e mauaina lau tausiga iinei i Amerika Samoa pe na e malaga atu i Honolulu, Kalifonia, po’o Filipaina mo se ta’otoga fa’apitoa, e tatau ona e malamalama i le mea ua tupu i lou tino ma po’o ā au aiā tatau i lalo o le tulafono a le Iunaite Setete.

Matou te iloa o le iloaina o se fa’afitauli i se mea fa’afoma’i i totonu o le tino o se mea e fa’atiga ai le mafaufau ma le tino. E masani ona amata i se lagona lē fiafia e lē mautinoa, o se suiga fa’afuase’i i le foliga o le fatafata, po’o se mū o le pa’u e lē mafai ona te’a. Mo le to’atele i Amerika Samoa, o le taulimaina o nei fa’afitauli e atili ai ona faigata ona o le mamao mai nofoaga fa’afoma’i fa’apitoa. I le The Manginello Law Firm, PLLC, lea e lauiloa o le Attorney911, ua luasefulu fitu tausaga o matou tau mo aiā tatau a i latou ua fa’amanualia. O la matou pa’aga pule, o Ralph Manginello, o lo’o i ai se tautinoga umi i le fa’amautinoaina o lo’o tali atu fa’alapotopotoga malolosi, o se tautinoga na fa’aalia talu ai nei i la matou matafaioi faufautua autū i le fa’amasinoga e $10,000,000 a le Bermudez v. Pi Kappa Phi. Matou te malamalama i lu’itau tulaga ese o lo’o feagai ma le faitau aofa’i o tagata mama’i i Amerika Samoa, ma o lo’o matou i ai iinei e tu’uina atu le poto masani fa’aletulafono ma fa’afoma’i e mana’omia e fa’asagatau atu ai i kamupani gaosi mea fa’afoma’i e faitau piliona tālā le tau.

Talu ai o Amerika Samoa o se vaega o le faiga fa’aletulafono a Amerika, o lo’o puipuia oe e tulaga saogalemu feterale tutusa ma manatu e uiga i le noataga o oloa o lo’o pulea ai le atunu’u tele. Peita’i, o lou avanoa i fa’amatalaga o nisi taimi e mafai ona punitia ona o le mamao. O lenei ta’iala ua mamanuina e fa’afeso’ota’i ai lenā avanoa, e tu’uina atu ai se punaoa a’ia’i i le fa’asaienisi o le fa’alētonu o le upega o le fatafata, le malepuepue o le va’ava’aia a le FDA, ma le ala fa’asolosolo i le mauaina o se taui mo fafine o Amerika Samoa.

Malamalama i Mea Fa’afoma’i: Upega, ADM, ma Scaffolds i Amerika Samoa

Ina ia finau mo oe lava, e tatau muamua ona e malamalama i mea o lo’o i totonu o lou tino. Pe a faia e foma’i tipitipi i le vaega o Amerika Samoa—pe o i latou o lo’o tautuaina o tatou tagata i Hawaii ma le West Coast—ni ta’otoga o le fatafata, e masani ona latou fa’aaogaina ni mea e “fa’amalosia” ai. O nei mea e pa’u’ū i vaega autū e tolu, o ia mea uma o lo’o i lalo o le va’ava’aiga malosi fa’aletulafono.

1. Acellular Dermal Matrix (ADM)

O le Acellular Dermal Matrix o se mea fa’alenatura (biologic) e maua mai i le pa’u o tagata po’o manu na foa’iina mai. O le vaega “acellular” o le igoa o lona uiga ua aveese sela o le tagata na foa’i mai, ae toe totoe na’o le auivi o le collagen. O lenei auivi e fa’amoemoe e mafai ai e au lava sela ona tupu i totonu, ma fa’amalosia ai le tino. O igoa masani (brands) o lo’o va’aia i fa’amaumauga a tagata mama’i i Amerika Samoa e aofia ai le AlloDerm (Allergan/AbbVie), Strattice, FlexHD (MTF Biologics), ma le AlloMax (Becton Dickinson).

2. Bioabsorbable ma Resorbable Scaffolds

E lē pei o le lagona “tumau” o upega masani, o le bioabsorbable scaffolds o ni mea faufau (synthetic) ua mamanuina ina ia mitiia e lou tino i le alu o le taimi (e masani lava 18 i le 24 masina). O le mea pito sili ona lauiloa o le GalaFLEX, e gaosia e le Galatea Surgical (lea ua ta’u nei o le Becton Dickinson), lea e faia mai se polymer e ta’u o le poly-4-hydroxybutyrate (P4HB). O isi oloa resorbable e aofia ai le upega o le Phasix ma le DuraSorb. O nei mea e masani ona fa’aaogaina i ta’otoga o le “internal bra” (itū’āiga matāfata i totonu) mo le mastopexy (si’i luga o le fatafata) po’o le lagolagoina o se mea fou ua fa’apipi’i i totonu (implant).

3. Upega Fa’afoma’i Faufau (Synthetic Surgical Mesh)

E ui e lē masani ai i ta’otoga o le fatafata i nei aso pei o le ADM po’o scaffolds, ae o isi foma’i tipitipi na fa’aaogaina upega masani o le polypropylene po’o upega palu (composite). O ia mea e le’i mamanuina lava mo le si’osi’omaga vaivai o le fatafata, ma o lo latou fa’aaogaina i ni auala e le’i fa’amaonia ua i’u ai i le ‘onomea o a’ano o le tino ma le tiga faifai pea mo tagata mama’i i Amerika Samoa ma isi nofoaga.

O le fa’afitauli autū o lo’o feagai ma fafine i Amerika Samoa, o le tele o nei oloa e le’i fa’amaoniaina manino lava e le FDA mo le fa’aaogaina i ta’otoga o le fatafata. Nai lo lenā, na latou o’o atu i le maketi e ala i se ala ‘alo (regulatory shortcut) e ta’ua o le 510(k), lea o le a tatou su’esu’eina au’ili’ili.

Le Fa’alētonu o le Pulega o le FDA: Mea e Tatau ona Iloa e Tagata Mama’i i Amerika Samoa

Mo le tele o tausaga, na fa’asalalau ai e kamupani gaosi mea nei oloa i foma’i tipitipi o lo’o tautuaina le alalafaga o Amerika Samoa o se “tulaga fou” mo le toe fa’aleleia o le fatafata. Peita’i, i le aso 9 o Novema, 2023, na tupu ai se suiga tele. Na tu’uina atu e le FDA se tusi aloa’ia i tagata e tu’uina atu tausiga fa’alesoifua maloloina e fa’ailoa ai se mea moni e tatau ona fa’afofoga i ai fafine uma i Amerika Samoa: “O le saogalemu ma le aoga o upega fa’afoma’i i ta’otoga o le fatafata, e aofia ai le fa’ateleina po’o le toe fa’aleleia, e le’i fa’amaoniaina e le FDA.”

O lenei tusi na ta’ua ai oloa a le Becton Dickinson (BD)—e aofia ai le GalaFLEX Scaffold, GalaFLEX Lite, ma le Phasix Mesh—ma maitauina e leai ni upega fa’afoma’i ua fa’amaonia e le FDA mo le fa’aaogaina i ta’otoga o le fatafata. Mo se tagata ma’i i Amerika Samoa, o lona uiga o le “internal bra” po’o le “ADM reinforcement” na ta’u atu ia te oe e saogalemu, o lo’o fa’aaogaina i se auala “off-label” (e aunoa ma le fa’amaoniga aloa’ia) e aunoa ma se fa’avae mausali o fa’amatalaga o le saogalemu.

Le Ala ‘Alo o le 510(k)

Na fa’apefea ona o’o atu nei oloa i totonu o potu tipitipi pe afai e le’i fa’amaonia? Na latou fa’aaogaina le ala ‘alo o le 510(k) (21 USC §360c). E lē pei o le faiga faigata o le Premarket Approval (PMA) lea e mana’omia mo mea e maualuga le lamatia ai, o le ala o le 510(k) e fa’atagaina ai se mea fa’afoma’i ona o’o atu i le maketi pe afai e fa’aalia e le kamupani gaosi o lenei mea e “toetoe lava tutusa” (substantially equivalent) ma se mea o lo’o i ai muamua i luga o le maketi.

E pei ona fa’amatala soo e Ralph Manginello i a matou tagata tautua, o lenei mea e mafai ai e se kamupani ona fa’atusatusa se mea e matua ese lava. I le tulaga o le GalaFLEX, mo se fa’ata’ita’iga, na fa’asino e le kamupani se filo mo su’isu’i (surgical suture) o se tasi lea o mea na fa’atusatusa i ai. O le filo (o se manoa e tasi) e matua ese lava mai se upega scaffold, ae na fa’atagaina e le FDA le fa’atusatusaga. O lenei faiga fa’aletulafono ua fa’atagaina ai mea e le’i fa’ata’ita’iina lava i luga o a’ano o le fatafata o tagata ina ia fa’apipi’i i totonu o le faitau afe o fafine, e aofia ai le to’atele i Amerika Samoa.

Le ‘Aonomea o Fa’afitauli mo Tagata o Amerika Samoa

O fa’afitauli e mafua mai i upega o le fatafata ma scaffolds fa’alētonu e amata mai i le leaga o foliga va’aia se’ia o’o atu i itū’āiga kanesa e lamatia ai le ola. Afai o lo’o e aumau i Amerika Samoa, e taua tele le va’ava’ai mo nei auga, aemaise lava pe afai na faia sau ta’otoga i le sefulu tausaga talu ai.

BIA-ALCL: Le Lymphoma e Feso’ota’i ma Mea Fa’apipi’i

O le Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) o se itū’āiga lymphoma (non-Hodgkin lymphoma) e tupu i totonu o le a’ano po’o le ‘aila (capsule) o lo’o si’omia ai le mea fa’apipi’i. E malosi tele lona feso’ota’iga ma mea fa’apipi’i e taaligoligo le pito i fafo (textured-surface implants), pei o oloa o le Allergan BIOCELL lea ua toe fa’afo’i (recalled).

• Auga: O tagata mama’i i Amerika Samoa e masani ona lipotia le fa’aputuga o le suavai (seroma) pe a mavae se taimi umi, fula fa’afuase’i, po’o se pona o lo’o tupu i le 7 i le 10 tausaga talu ona mae’a le ta’otoga muamua.
• Le Toe Fa’afo’iina (Recall): I luga o le Iulai 2019, na talosagaina ai e le FDA se toe fa’afo’iina ma le lotomalie o mea fa’apipi’i taaligoligo a le Allergan BIOCELL ona o tagata o lo’o i ai nei mea e tusa ma le ono taimi e sili atu ai lo latou avanoa e maua ai lenei kanesa.

BIA-SCC: Ni Tulaga Fou o le Kanesa

I le masina o Setema 2022 ma toe fo’i i le Mati 2023, na tu’uina atu ai e le FDA ni lapata’iga saogalemu e uiga i le Breast Implant-Associated Squamous Cell Carcinoma (BIA-SCC). O lenei tumoa squamous e ese mai le BIA-ALCL ma ua maua i totonu o ‘aila o fagu fatafata o lo’o lamolemole ma i latou o lo’o taaligoligo. Mo se tama’ita’i i Amerika Samoa, so’o se pona fou po’o se tiga faifai pea i tafatafa o se matāfata tuai—e tusa lava pe lamolemole—e tatau ona su’esu’eina e se foma’i fa’apitoa.

Red Breast Syndrome (RBS)

O se fula tuga lea e patino i le acellular dermal matrix (ADM). E lē pei o se si’omaga (infection), e leai ni siama o iai; nai lo lenā, e talitonuina o lenei tulaga e mafua mai i endotoxins (otaota mai siama) na totoe i luga o le ADM i le taimi o le gaosiga. O tagata mama’i i Amerika Samoa o lo’o mafatia i le RBS o le a va’aia se mamanu mū sesega ma le mautinoa i luga o le pa’u o le fatafata e lē tali atu i vaila’au foma’i (antibiotics) ae e masani ona te’a pe a aveese le ADM.

Fa’alētonu o le Puipuiga ma le Fa’amalologa

E ese mai i le lamatia i le kanesa, o le bioabsorbable scaffolds pei o le GalaFLEX ma le ADMs pei o le FlexHD e mafai ona i’u i le:

• Skin-flap necrosis: O le mate o le pa’u o le fatafata i luga a’e o le mea fa’apipi’i.
• Extrusion: O le upega po’o le scaffold o lo’o uia le pa’u ma aliali mai i fafo.
• Tiga Faifai Pea: E masani ona mafua mai i le tali atu o le tino i se mea e lē mafai ona ia mitiia lelei.
• Fa’alētonu o le Toe Fa’aleleia: Pe a lē mafai e le mea lagolago ona taofi le mamafa, e i’u ai i le pa’ū i lalo o le fatafata po’o le leiloa atoatoa o le i’uga o le ta’otoga.

Afai o lo’o e feagai ma se tasi o nei fa’afitauli, e lē na’o se “tulaga faigata” oe. Atonu o oe o se tasi ua a’afia i se oloa fa’alētonu. O Ralph Manginello ma la matou ‘au atoa i le Attorney911 o lo’o i ai le tomai fa’apitoa e su’esu’e ai pe o se vaega patino o le upega po’o se itū’āiga ADM o le pogai lea o lou lavea.

Advocacy Fa’aletulafono mo le Nu’u o Amerika Samoa: Aiseā o le Attorney911?

O le taulimaina o se tagi mo le noataga o oloa mai Amerika Samoa e mana’omia ai se kamupani loia e le gata ina i ai se sootaga i le lotoifale; e mana’omia ai se kamupani e i ai se malosiaga o su’esu’ega i le atunu’u atoa ma se pulega maualuga i taualumaga a le fa’amasinoga feterale. O Ralph Manginello sa maua lona laisene talu mai le 1998, ma aumaia le luasefulu fitu tausaga o le poto masani i mataupu ta’itasi. Matou te fa’atagaina e tū i luma o le Fa’amasinoga a le Iunaite Setete mo le Itū i Saute o Texas, o se nofoaga tutotonu mo fa’amasinoga o mea fa’afoma’i e maualuga le taua.

Le Avanoa i Gagana e Lua: Lupe Peña

Matou te malamalama o Amerika Samoa o se alalafaga e tele gagana e fa’aaogaina. O le talanoaga ma lau loia e le tatau lava ona mana’omia ai se fa’aliliu upu. O le loia lagolago o Lupe Peña e faia fa’atalatalanoaga atoa ma tagata tautua i le gagana Sipaniolo ma le Igilisi ma le mautinoa. O lenei feso’ota’iga tu’usa’o i le va o le loia ma le tagata ma’i e mautinoa ai e leai se vaega o lau talafa’asolopito fa’afoma’i po’o lou tiga e galo pe leiloa i le fa’aliliuga. O le talaaga o Lupe i le puipuiga o inisiua (insurance defense) e maua ai e a matou tagata se va’aiga fa’apitoa i le auala o le a taumafai ai loia a kamupani gaosi mea e te’ena lau tagi.

Malosiaga Fa’amasino ua Fa’amaonia

O la matou kamupani o lo’o avea nei ma faufautua autū i le Bermudez v. Pi Kappa Phi, o se mataupu tele e $10,000,000 ma le tele o ē ua molia lea na i’u ai i le tapunia o fa’alapotopotoga ma le fa’alauiloaina i le atunu’u atoa e feso’ota’iga tala fou pei o le ABC13, KPRC 2, ma le KHOU 11. O le itū’āiga lagolago lē fefe lenei matou te aumaia i mataupu o mea fa’afoma’i fa’alētonu. Pe a matou talia se mataupu fa’asaga i se kamupani gaosi oloa pei o le Becton Dickinson po’o le Allergan, matou te aumaia le malosiaga tutusa o le tulafono na matou fa’aaogaina i a matou mataupu pito sili ona lauiloa.

Pe a e vili i le 1-888-ATTY-911, o lo’o e maua atu se kamupani loia ua sili atu i le $50,000,000 le taui ua maua mo tagata tautua. Matou te fa’amamaluina fafine i Amerika Samoa ma le amana’ia e tatau ai, ma tu’uina atu se tulaga o le tautua fa’aletulafono e tatau ma le lavelave o fa’afitauli fa’afoma’i o lo’o feagai ai.

Le Ta’iala a le Puipuiga: Auala o le a Finau ai Kamupani Gaosi Mea Fa’asaga ia te Oe

Afai e te failaina se tagi i Amerika Samoa, e tatau ona e fa’amoemoe o le a tau fa’asaga mai le au gaosi oloa e fa’aaoga ai se seti o puipuiga fa’aletulafono e masani ona va’aia. O la matou matafaioi o le va’ai mamao ma le fa’aleaogaina o nei finauga.

1. Federal Preemption (Le Puipuiga a Riegel)

O le au gaosi oloa e masani lava ona fa’asino i le mataupu o le Riegel v. Medtronic (552 U.S. 312) e finau ai e fa’apea, talu ai o le latou mea fa’afoma’i na “fa’amaonia” e le FDA, e lē mafai ona e molia i latou i le fa’amasinoga a le setete. Peita’i, talu ai o le tele o upega fatafata ma oloa ADM na o’o atu i le maketi e ala i le ala o le 510(k) (Medtronic v. Lohr), latou te lē mauaina le puipuiga tutusa ma mea fa’afoma’i o le Class III ia na uia le fa’agasologa atoa o le premarketing approval. Matou te iloa le auala e finau ai le fa’asao mo le “parallel-claim” ina ia mautinoa e fa’afofogaina lou leo i le fa’amasinoga.

2. Le Matā’upu o le “Learned Intermediary”

O le a latou finau mai e fa’apea na latou “lapata’ia le foma’i tipitipi,” ma o so’o se lē taulau ona tu’uina atu lenā lapata’iga ia te oe o le sese lea o le foma’i. I le Attorney911, matou te tali atu i lenei mea e ala i le su’eina o fa’amaoniga o le fa’alauiloaina o oloa mo ni auala e le’i fa’atagaina (off-label). Afai sa i ai se sui o kamupani i totonu o le potu tipitipi i Honolulu po’o Los Angeles o lo’o a’oa’oina lau foma’i i le auala e fa’aaoga ai le GalaFLEX i se auala e le’i fa’amaonia e le FDA, atonu ua leiloa e le kamupani la latou puipuiga o le “learned intermediary.”

3. Le Talatu’u o le “Fa’afitauli e Seāseā Tupu”

O le a latou ta’u atu ia te oe o le BIA-ALCL po’o le red breast syndrome e tupu i le “tasi i le miliona.” Matou te fa’aaogaina fa’amatalaga fa’afoma’i fou—e aofia ai le mea moni e fa’apea o le lamatia i le Allergan BIOCELL e mafai ona maualuga e pei o le 1 i le 2,207 i isi vaega—e fa’amaonia ai o nei manunu’a o se i’uga o a latou filifiliga i le mamanu o oloa.

Fesili e Masani ona Fesiligia mo Tagata Mama’i i Amerika Samoa

Pe na matua fa’amaonia le GalaFLEX mo ta’otoga o le fatafata?
E leai. Na fa’amaonia e le FDA i le masina o Novema 2023 e leai ni upega fa’afoma’i, e aofia ai le GalaFLEX, ua fa’amaonia mo le fa’aaogaina i ta’otoga o le fatafata. O lo’o fa’aaogaina i se auala e le’i fa’amaoniaina aloa’ia.

Ae a pe afai na fai la’u ta’otoga i Hawaii po’o Kalifonia ae ua ou nofo nei i Amerika Samoa?
O le nofoaga mo le fa’amasinoga e mafai ona lavelave, ae e masani lava ona iai lau aiā tatau e su’e ai se loia i le mea o lo’o e aumau ai po’o le mea na iloa ai lou manu’a. Talu ai matou te fa’atagaina i le fa’amasinoga feterale (Itū i Saute o Texas), e mafai ona matou fa’amaopoopoina tagi mo le atunu’u atoa mo tagata o Amerika Samoa tusa lava po’o fea na fai ai le ta’otoga muamua.

E fa’apefea ona ou iloa po’o le a le mea na tu’u i lo’u tino?
E iai lau aiā tatau fa’aletulafono i au fa’amaumauga fa’afoma’i. E tatau ona e talosagaina lau “Operative Report” ma le “Implant Logs” mai le falema’i. O nei fa’amaumauga o lo’o iai ni fa’ailoga “UDI” (Unique Device Identifier) o lo’o lisiina ai le brand, le numera o le vaega (lot number), ma le kamupani gaosi mea. Afai e te fa’alavelave i le mauaina o nei mea, e mafai e le matou kamupani ona fesoasoani.

O le ā le taimi fa’atapula’aina (statute of limitations) i Amerika Samoa?
O aso fa’atapula’a e faila ai se tagi e eseese. I le tele o tulaga, e fa’aaogaina le “tulafono o le iloaina” (discovery rule), o lona uiga e amata le taimi pe a e fa’ato’ā iloa—pe sa tatau ona e iloa—o lou manu’a e feso’ota’i ma le mea fa’afoma’i. Mo le to’atele, o lenā iloiloga na tupu ina ua tu’uina atu e le FDA ana tusi lapata’i i le 2021, 2022, po’o le 2023. E tatau ona e vili le 1-888-ATTY-911 i le taimi lava lea ina ia puipuia lau aiā tatau e faila ai se tagi.

Po o tatau ona ou totogiina muamua se tupe?
E leai. Matou te galulue i luga o se faiga e ta’ua o le “contingency fee.” O lona uiga matou te totogiina uma tau o le fa’amasinoga, ma e te lē totogiina mai ia i matou se mea—e leai lava—se’i vagana ua matou maua se taui tupe mo oe.

O le Tagata Fa’ailoa Mea lē sa’o (Whistleblower): Dr. Hooman Noorchashm ma le GalaFLEX

O se vaega taua o le mataupu fa’asaga i le Becton Dickinson (BD) o lo’o aofia ai fa’amaumauga a Dr. Hooman Noorchashm. O se sa avea muamua ma Fa’atonu Fa’afoma’i i le BD, o Dr. Noorchashm na fa’ate’a i le 2022 ina ua uma ona ia laga ni popolega e uiga i le saogalemu o le GalaFLEX i tagata mama’i o le kanesa o le fatafata. Na ia tu’ua’ia fa’alaua’itele e fa’apea na taofi e le BD ni fa’amatalaga e uiga i le toe tupu o le kanesa o le fatafata i a latou su’esu’ega fa’afoma’i ma sa latou faia ni fa’ata’ita’iga e le’i fa’atagaina i fafine. Mo se tagata ma’i i Amerika Samoa o lo’o feagai ma le toe tupu o le kanesa fa’atasi ai ma le fa’alētonu o le upega, o lenei molimau o se fa’amaoniga malosi lea na iloa lelei e le kamupani le mafaia ona tupu o lenei afaina.

Taui i Tupe ma le Mea Moni o le Totogiina o ni Maliega

E ui e leai se loia e mafai ona fa’amautinoaina se aofa’iga patino o tupe, e mafai ona tatou va’ai i talaaga o fa’amasinoga o upega ma mea fa’afoma’i. I le 2024, na malie ai le Becton Dickinson e totogi le tusa ma le $1 piliona e fo’ia ai tagi o le hernia mesh. O fa’amasinoga o upega i lalo o le manava (pelvic mesh) na i’u ai i le silia ma le $8 piliona le taui na totogi atu i le silia ma le 100,000 fafine. O fa’ai’uga a le fa’amasinoga mo manu’a tuga i ta’otoga o le fatafata e aofia ai le si’omaga ma le fa’alētonu o foliga va’aia ua o’o atu i le faitau miliona o tālā.

Mo fafine o Amerika Samoa, o mea e mafai ona maua ai le taui (damages) e aofia ai:

• Taui o Tupe (Economic Damages): Tau mo ta’otoga e toe sui ai, le aveeseina o le mea fa’apipi’i, le va’ava’aia fa’afoma’i mo le lumana’i, ma tupe na leiloa ona o le lē mafai ona faigaluega.
• Taui e Lē o ni Tupe (Non-Economic Damages): Tiga ma mafatiaga, mafatiaga o le mafaufau, ma le fa’aleagaina tumau o foliga va’aia.
• Taui Fa’asalaga (Punitive Damages): I mataupu e mafai ona matou fa’aalia ai na gaoioi le kamupani ma le fa’atamala tele pe na nanā ni tulaga lamatia na latou iloa.

Lou Ala i luma i Amerika Samoa

Afai o oe o se tasi na sao mai le kanesa o le fatafata i Amerika Samoa o lo’o va’ai atu i le fa’alētonu o le toe fa’aleleia o lou fatafata, po’o se tagata fo’i na faia se ta’otoga fa’amatagofie ae ua i ai se pona fou, aua ne’i le amana’ia lou tino. O lou manuia lelei o le mea pito sili lea ona taua. Fa’afeso’ota’i vave lau foma’i e talanoaina au auga. Pe a mautu lou soifua maloloina, o lau isi vili e tatau ona agai i le The Manginello Law Firm, PLLC.

O i matou o se kamupani loia o lo’o mautu i fa’amasinoga e maualuga le taua, ma o lo’o iai le fa’ailoga e 8.2 le “Excellent” mai le Avvo ma le Martindale-Hubbell Preeminent status. O Ralph Manginello ma Lupe Peña o lo’o sauni e fa’afofoga i lau tala. Matou te ofoina atu fa’atalatalanoaga e aunoa ma se totogi ma o ni mea lilo i tagata o lo’o aumau i Amerika Samoa, ma o lo’o matou tautino atu e tu’uina atu le maualuga lava o le tautua fa’aletulafono i atumotu o le Pasefika e pei ona matou faia i le fatu o Texas.

E te lē o tu’ua na’o oe. O lo’o i ai le faitau afe o fafine i le atunu’u atoa—ma iinei i Amerika Samoa—o lo’o faimalaga i nei lava fa’afitauli. Ua matou fausia lo matou ta’uta’ua i le tau mo tagata lautele, ae le o i latou o lo’o i ai le malosi. Pe a e sauni e fai le isi la’asaga, vili mai i matou i le 1-888-ATTY-911 (1-888-288-9911). Hablamos español.

Attorney911: Lou leo i luma o le fa’atamala a kamupani tetele. O lo’o tautuaina Amerika Samoa ma le luasefulu fitu tausaga o le malosiaga fa’aletulafono.

Fa’ailo: O lenei fa’amatalaga polokalame e mo na’o le a’oa’oga ma e lē avea o se fautuaga fa’afoma’i po’o se fautuaga fa’aletulafono. O i’uga i aso ua mavae e lē fa’amaonia ai ni i’uga i le lumana’i. O le Manginello Law Firm, PLLC (Attorney911) o se kamupani o lo’o fa’amautu i Texas ma le fa’atagaga i le fa’amasinoga feterale ma le mafaia ona fa’amaopoopoina fa’amasinoga i le atunu’u atoa. Fa’afeso’ota’i mai i matou mo se fa’atalatalanoaga e aunoa ma se totogi e uiga i lau mataupu patino i Amerika Samoa.

ENGLISH

Defective Breast Mesh, Acellular Dermal Matrix, and Bioabsorbable Scaffold Injury Attorneys in American Samoa: The Complete Guide for Women, Families, and Survivors

For women in American Samoa who have undergone breast reconstruction, cosmetic augmentation, or revision surgery, the path to healing is often marked by resilience. However, for many in our community, that path has been obstructed by the failure of surgical devices—specifically acellular dermal matrix (ADM), bioabsorbable scaffolds like GalaFLEX, and textured implants—that were marketed as safe but have since been linked to catastrophic complications. Whether you received your care locally in American Samoa or traveled to Honolulu, California, or the Philippines for a specialized procedure, you deserve to understand what has happened to your body and what your legal rights are under United States law.

We recognize that the discovery of a medical device failure is a traumatic event. It often begins with a vague feeling of discomfort, a sudden change in breast shape, or a persistent redness that won’t go away. For many in American Samoa, navigating these complications is made even more difficult by the geographical distance from specialized tertiary care centers. At The Manginello Law Firm, PLLC, known as Attorney911, we have spent twenty-seven years fighting for the rights of the injured. Our managing partner, Ralph Manginello, has a long-standing commitment to holding powerful institutions accountable, a dedication recently demonstrated in our lead counsel role in the $10,000,000 Bermudez v. Pi Kappa Phi litigation. We understand the unique challenges faced by the American Samoa patient population, and we are here to provide the sophisticated legal and medical command necessary to take on multi-billion-dollar device manufacturers.

Because American Samoa is a part of the American legal landscape, you are protected by the same federal safety standards and product liability theories that govern the mainland. However, your access to information can sometimes be gated by distance. This guide is designed to bridge that gap, providing a definitive resource on the science of breast mesh failure, the breakdown of FDA regulatory oversights, and the procedural path to securing compensation for the women of American Samoa.

Understanding the Devices: Mesh, ADM, and Scaffolds in American Samoa

To advocate for yourself, you must first understand the materials that may be present in your body. When surgeons in the American Samoa area—or those serving our residents in Hawaii and the West Coast—perform breast procedures, they often use “reinforcement” materials. These fall into three primary categories, all of which are currently under intense legal and regulatory scrutiny.

1. Acellular Dermal Matrix (ADM)

Acellular Dermal Matrix is a biologic material derived from donated human or animal skin. The “acellular” part of the name means that the donor’s cells have been stripped away, leaving only a collagen framework. This framework is intended to allow your own cells to grow into it, reinforcing the tissue. Common brands seen in American Samoa patient records include AlloDerm (Allergan/AbbVie), Strattice, FlexHD (MTF Biologics), and AlloMax (Becton Dickinson).

2. Bioabsorbable and Resorbable Scaffolds

Unlike the “permanent” feel of traditional mesh, bioabsorbable scaffolds are synthetic materials designed to be absorbed by your body over time (usually 18 to 24 months). The most prominent of these is GalaFLEX, manufactured by Galatea Surgical (now Becton Dickinson), which is made of a polymer called poly-4-hydroxybutyrate (P4HB). Other resorbable products include Phasix mesh and DuraSorb. These are often used in “internal bra” procedures for mastopexy (breast lifts) or to support a new implant.

3. Synthetic Surgical Mesh

While less common in modern breast surgery than ADM or scaffolds, some surgeons have used traditional polypropylene or composite meshes. These materials were never designed for the delicate environment of the breast envelope, and their off-label use has led to significant tissue erosion and chronic pain for patients in American Samoa and beyond.

The core issue facing women in American Samoa is that many of these products were never explicitly cleared by the FDA for use in breast surgery. Instead, they reached the market through a regulatory shortcut known as the 510(k) pathway, which we will examine in detail.

The FDA Regulatory Failure: What American Samoa Patients Need to Know

For years, manufacturers marketed these products to surgeons serving the American Samoa community as the “new standard” for breast reconstruction. However, on November 9, 2023, a significant shift occurred. The FDA issued a formal letter to health care providers stating a fact that every woman in American Samoa should hear: “The safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.”

This letter named the Becton Dickinson (BD) product lines—including GalaFLEX Scaffold, GalaFLEX Lite, and Phasix Mesh—noting that no surgical mesh products have been cleared or approved by the FDA for use in breast surgery. For a patient in American Samoa, this means the “internal bra” or the “ADM reinforcement” you were told was safe was technically being used and promoted “off-label” without a confirmed foundation of safety data.

The 510(k) Loophole

How did these products end up in operating rooms if they weren’t approved? They used the 510(k) clearance pathway (21 USC §360c). Unlike the rigorous Premarket Approval (PMA) process required for higher-risk devices, the 510(k) pathway allows a device to reach the market if the manufacturer shows it is “substantially equivalent” to a “predicate” device already on the market.

As Ralph Manginello often explains to our clients, this creates a “predicate creep.” In the case of GalaFLEX, for example, the manufacturer cited a surgical suture as one of its predicates. A suture (a single thread) is fundamentally different from a mesh scaffold, yet the FDA permitted the comparison. This regulatory framework has allowed materials that have never been clinically tested in human breast tissue to be implanted in thousands of women, including many in American Samoa.

The Spectrum of Complications for American Samoa Residents

The complications resulting from defective breast mesh and scaffolds range from aesthetic failures to life-threatening malignancies. If you reside in American Samoa, it is vital to monitor for these symptoms, particularly if you have undergone surgery within the last decade.

BIA-ALCL: The Implant-Associated Lymphoma

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a distinct type of non-Hodgkin lymphoma that develops in the scar tissue (capsule) around the implant. It is highly associated with textured-surface implants, such as the now-recalled Allergan BIOCELL products.

• Pathology: BIA-ALCL is defined by CD30-positive and ALK-negative T-cells.
• Presentation: Patients in American Samoa often report late-onset seroma (fluid buildup), sudden swelling, or a mass appearing 7 to 10 years after the original surgery.
• The Recall: In July 2019, the FDA requested a voluntary recall of Allergan BIOCELL textured implants because patients with these devices were roughly six times more likely to develop this cancer.

BIA-SCC: Emerging Cancer Risks

In September 2022 and again in March 2023, the FDA issued safety communications regarding Breast Implant-Associated Squamous Cell Carcinoma (BIA-SCC). This epithelial tumor is distinct from BIA-ALCL and has been found in the capsules of both smooth and textured implants. For a woman in American Samoa, any new lump or persistent pain around an old implant—even a smooth one—must be evaluated by a specialist.

Red Breast Syndrome (RBS)

This is a sterile inflammatory response specific to acellular dermal matrix (ADM). Unlike an infection, there are no bacteria present; instead, the condition is believed to be caused by endotoxins (bacterial debris) left on the ADM during the manufacturing process. Patients in American Samoa suffering from RBS will see a bright red, well-defined patch on the skin of the breast that does not respond to antibiotics but often disappears if the ADM brand is exchanged or removed.

Mechanical and Healing Failures

Beyond the risk of cancer, bioabsorbable scaffolds like GalaFLEX and ADMs like FlexHD can lead to:

• Skin-flap necrosis: The death of the breast skin over the implant.
• Extrusion: The mesh or scaffold literally poking through your skin.
• Chronic Pain: Often caused by the body’s inflammatory reaction to a material it cannot properly absorb.
• Reconstruction Failure: When the reinforcement material fails to provide support, leading to “bottoming out” or a total loss of the surgical result.

If you are experiencing any of these issues, you are not just a “difficult case.” You may be the victim of a defective product. Ralph Manginello and our entire team at Attorney911 have the technical command to investigate whether a specific lot of mesh or a specific ADM brand is the culprit in your injury.

Legal Advocacy for the American Samoa Community: Why Attorney911?

Navigating a product liability claim from American Samoa requires a firm with more than just a local presence; it requires a firm with a national litigation footprint and a deep command of federal court procedures. Ralph Manginello has been licensed since 1998, bringing twenty-seven years of continuous practice experience to every case. We are admitted to the United States District Court for the Southern District of Texas, a venue centrally located for high-stakes device litigation.

The Bilingual Advantage: Lupe Peña

We understand that American Samoa is a multilingual community. Communication with your attorney should never require an interpreter. Associate attorney Lupe Peña conducts full client consultations in fluent Spanish. This direct attorney-client communication ensures that no nuance of your medical history or your pain is lost in translation. Lupe’s background in insurance defense provides our clients with an “insider” view of how the manufacturers’ lawyers will try to deny your claim.

Proven Litigation Power

Our firm is currently lead counsel in Bermudez v. Pi Kappa Phi, a high-profile $10,000,000 multi-defendant case that resulted in institutional shutdowns and national media coverage from ABC13, KPRC 2, and KHOU 11. This is the level of aggressive advocacy we bring to defective device cases. When we take on a manufacturer like Becton Dickinson or Allergan, we bring the same structural command of institutional liability that we use in our most public-facing cases.

When you call 1-888-ATTY-911, you reach a firm that has recovered over $50,000,000 for clients. We treat women in American Samoa with the dignity they deserve, providing a level of legal service that matches the sophistication of the medical issues at hand.

The Defense Playbook: How Manufacturers Will Argue Against You

If you file a claim in American Samoa, you should expect the manufacturers to fight back using a predictable set of legal defenses. Our role is to anticipate and neutralize these arguments.

1. Federal Preemption (The Riegel Defense)

Manufacturers often point to Riegel v. Medtronic (552 U.S. 312) to argue that because their device was “cleared” by the FDA, you can’t sue them in state court. However, because most breast mesh and ADM products reached the market via the 510(k) pathway (Medtronic v. Lohr), they do not enjoy the same preemption protection as Class III devices that went through full premarketing approval. We know how to argue the “parallel-claim” exception to ensure your voice is heard in court.

2. The Learned Intermediary Doctrine

They will argue that they “warned the surgeon,” and therefore, any failure to pass that warning to you is the doctor’s fault. At Attorney911, we counter this by looking for evidence of off-label promotion. If a sales rep was in the operating room in Honolulu or Los Angeles coaching your surgeon on how to use GalaFLEX in a way the FDA never approved, the manufacturer may have lost their “learned intermediary” shield.

3. The “Rare Complication” Myth

They will tell you that BIA-ALCL or red breast syndrome is “one in a million.” We use the latest clinical data—including the fact that Allergan BIOCELL risk can be as high as 1 in 2,207 in certain cohorts—to prove that these injuries are a foreseeable result of their design choices.

Frequently Asked Questions for American Samoa Patients

Is GalaFLEX actually cleared for breast surgery?
No. The FDA confirmed in November 2023 that no surgical mesh products, including the GalaFLEX line, have been cleared or approved for use in breast surgery. It is used off-label.

What if I had my surgery in Hawaii or California but live in American Samoa now?
Jurisdiction and venue can be complicated, but you generally have the right to seek counsel where you live or where the injury was discovered. Because we are admitted to federal court (Southern District of Texas), we can coordinate national claims for American Samoa residents no matter where the original surgery occurred.

How do I find out what was used in my body?
You have a legal right to your medical records. You should request your “Operative Report” and “Implant Logs” from the hospital. These records contain “UDI” (Unique Device Identifier) stickers that list the brand, lot number, and manufacturer. If you have trouble getting these, our firm can assist.

What is the statute of limitations in American Samoa?
The deadlines to file a claim vary. In many cases, the “discovery rule” applies, meaning the clock starts when you first learned—or should have learned—that your injury was linked to the device. For many, that discovery happened when the FDA issued its safety letters in 2021, 2022, or 2023. You should call 1-888-ATTY-911 immediately to protect your right to file.

Will I have to pay upfront?
Never. We operate on a contingency fee basis. This means we advance all the costs of the litigation, and you pay us nothing—zero—unless we recover compensation for you.

The Whistleblower: Dr. Hooman Noorchashm and GalaFLEX

A material part of the case against Becton Dickinson (BD) involves the whistleblower record of Dr. Hooman Noorchashm. A former Medical Director at BD, Dr. Noorchashm was terminated in 2022 after raising concerns about the safety of GalaFLEX in breast cancer patients. He has publicly alleged that BD withheld data regarding breast cancer recurrences in their clinical trials and engaged in unauthorized experimentation on women. For a patient in American Samoa who may be dealing with a cancer recurrence alongside a mesh failure, this testimony is a powerful piece of evidence that the manufacturer was on notice of the potential for harm.

Financial Payouts and Settlement Reality

While no attorney can guarantee a specific dollar amount, we can look at the historical context of mesh and device litigation. In 2024, Becton Dickinson agreed to a roughly $1 billion settlement to resolve hernia mesh claims. Pelvic mesh litigation has resulted in over $8 billion in payments to more than 100,000 women. Individual verdicts for severe breast surgery injuries involving infection and disfigurement have reached into the multi-millions.

For the women of American Samoa, damages can include:

• Economic Damages: Costs for revision surgery, explantation, future medical monitoring, and lost wages.
• Non-Economic Damages: Pain and suffering, emotional distress, and permanent disfigurement.
• Punitive Damages: In cases where we can show the manufacturer acted with gross negligence or concealed known risks.

Your Path Forward in American Samoa

If you are a breast cancer survivor in American Samoa who is watching her reconstruction fail, or an aesthetic patient who has developed a new lump, do not ignore your body. Your well-being is the priority. Contact your healthcare provider immediately to discuss your symptoms. Once your health is stabilized, your next call should be to The Manginello Law Firm, PLLC.

We are a firm rooted in high-stakes litigation, with an 8.2 “Excellent” Avvo rating and Martindale-Hubbell Preeminent status. Ralph Manginello and Lupe Peña are ready to listen to your story. We offer free, confidential consultations to residents of American Samoa, and we are committed to providing the same level of white-glove legal representation to the Pacific islands that we provide in the heart of Texas.

You are not alone. There are thousands of women across the country—and here in American Samoa—navigating these same failures. We have built our reputation on fighting for the people, not the powerful. When you are ready to take the next step, call us at 1-888-ATTY-911 (1-888-288-9911). Hablamos español.

Attorney911: Your voice in the face of corporate negligence. Serving American Samoa with twenty-seven years of litigation power.

Disclaimer: This content is for educational purposes only and does not constitute medical or legal advice. Past results do not guarantee future outcomes. The Manginello Law Firm, PLLC (Attorney911) is a Texas-based firm with federal court admissions and the capacity to coordinate national litigation. Contact us for a free consultation regarding your specific case in American Samoa.