MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) UNK INSPIRA SOFT-TOUCH GEL; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number UNK INSPIRA SOFT-TOUCH GEL

Device Problems Folded (2630); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seroma (2069); Swollen Lymph Nodes (2093); Breast Mass (2439); Anaplastic Large Cell Lymphoma (3264)

Event Date 07/07/2016

Event Type  Injury  

Manufacturer Narrative

Article citation: mintsje de boer, md; wouter b.Van der sluis, md, phd; jan p.De boer, md, phd; lucy i.H.Overbeek, phd; flora e.Van leeuwen, phd; hinne a.Rakhorst, md, phd; rené r.W.J.Van der hulst, md, phd; nathalie j.Hijmering, msc; mark-bram bouman, md, phd; and daphne de jong, md, phd.¿breast implant-associated anaplastic large-cell lymphoma in a transgender woman." aesthetic surgery journal 2017, vol 37(8) np83¿np87.The events of alcl, seroma, and lump/nodule are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling: do not treat capsular contracture by closed capsulotomy or forceful external compression, which will likely result in implant damage, rupture, folds, and/or hematoma.The following things may cause implants to rupture: damage by surgical instruments, stressing the implant during implantation and weakening it, folding or wrinkling of the implant shell, excessive force to the chest (e.G., during closed capsulotomy, which is contraindicated), trauma, compression during mammographic imaging, and severe capsular contracture.Breast implants may also simply wear out over time.Laboratory studies have identified some of the causes of rupture for allergan¿s product.It is not conclusively known whether these tests have identified all causes of rupture.Laboratory studies to identify any additional causes of rupture are ongoing.Potential adverse events that may occur with silicone gel-filled breast implant surgery include: implant rupture, capsular contracture, reoperation, implant removal, pain, changes in nipple and breast sensation, infection, scarring, asymmetry, wrinkling, implant displacement/migration, implant palpability/visibility, breastfeeding complications, hematoma/seroma, implant extrusion, necrosis, delayed wound healing, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy.After breast implant surgery the following may occur and/or persist, with varying intensity and/or for a varying length of time: hematoma/seroma, implant extrusion, necrosis, delayed wound healing, and breast tissue atrophy/chest wall deformity.Based on information reported to fda and found in medical literature, a possible association has been identified between breast implants and the rare development of anaplastic large cell lymphoma (alcl), a type of non- hodgkin¿s lymphoma.Women with breast implants may have a very small but increased risk of developing alcl in the fluid or scar capsule adjacent to the implant.Alcl has been reported globally in patients with an implant history that includes allergan¿s and other manufacturers¿ breast implants.You should consider the possibility of alcl when you have a patient with late onset, persistent peri-implant seroma.In some cases, patients presented with capsular contracture or masses adjacent to the breast implant.When testing for alcl, collect fresh seroma fluid and representative portions of the capsule, and send for pathology tests to rule out alcl.If your patient is diagnosed with peri-implant alcl, develop an individualized treatment plan in coordination with a multi-disciplinary care team.Because of the small number of cases worldwide, there is no defined consensus treatment regimen for peri-implant alcl.

Event Description

Article ¿breast implant-associated anaplastic large-cell lymphoma in a transgender woman¿ reported ¿progressive late-onset periprosthetic seroma of the left breast.¿ and diagnosis of alcl.Pathological markers alk- and cd30+ confirmed.Device was removed and not replaced.Article additionally reports "implant is distinguishable by its folded surface" and "no infiltrating component of the tumor was observed, despite lymphohistiocytic inflammatory infiltrate in the capsule tissue.".

Event Description

Imaging report additionally reported foreign-body giant cell reaction.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.The event of lymphoma - alcl is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.

Event Description

Article ¿breast implant-associated anaplastic large-cell lymphoma in a transgender woman¿ reported ¿progressive late-onset periprosthetic seroma of the left breast.¿ and diagnosis of alcl.Pathological markers alk- and cd30+ confirmed.Device was removed and not replaced.Article additionally reports "implant is distinguishable by its folded surface" and "no infiltrating component of the tumor was observed, despite lymphohistiocytic inflammatory infiltrate in the capsule tissue.".

• Brand Name: UNK INSPIRA SOFT-TOUCH GEL
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 6882279
• MDR Text Key: 87160375
• Report Number: 9617229-2017-02128
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P020056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK INSPIRA SOFT-TOUCH GEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2011068-7/2/19-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 56 YR
• Patient Sex: Male