MAUDE Adverse Event Report: UNKNOWN MANUFACTURER UNK MAMMARY IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number UNK MAMMARY IMPLANT

Device Problems Biofilm coating in Device (1062); Patient-Device Incompatibility (2682)

Patient Problems Capsular Contracture (1761); Unspecified Infection (1930); Anaplastic Large Cell Lymphoma (3264)

Event Date 06/15/2016

Event Type  Injury  

Manufacturer Narrative

The events 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 addresses: "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.Potential adverse events that may occur with breast implant surgery include:.Reoperation, implant removal, infection.Patients should be advised that capsular contracture may be more common following infection, hematoma, and seroma, and the chance of it happening may increase over time.Capsular contracture occurs more commonly in revision patients than in primary augmentation or reconstruction patients.Capsular contracture is also a risk factor for implant deflation, and it is one of the most common reasons for reoperation.Patients should also be advised that additional surgery may be needed in cases where pain and/or firmness are severe.This surgery ranges from removal of the implant capsule tissue to removal and possible replacement of the implant itself.This surgery may result in loss of breast tissue.Capsular contracture may happen again after these additional surgeries.Capsular contracture may increase the risk of deflation." (b)(4).

Event Description

Literature article ¿bacterial biofilm infection detected in breast implant-associated anaplastic large-cell lymphoma¿ reports ¿twenty-six breast implant¿associated alcl samples were gathered from four centers for this international collaborative study from a total of 22 patients (table 1).¿ article goes on to state: ¿both the breast implant¿associated alcl and nontumor capsule samples yielded high mean numbers of bacteria (breast implant¿associated alcl, 4.7 × 106 cells/mg of tissue; capsule, 4.9 × 106 cells/mg of tissue).Analysis of the microbiome in breast implant¿associated alcl specimens showed significant differences with species identified in nontumor capsule specimens.There was a significantly greater proportion of ralstonia spp.Present in alcl specimens compared with nontumor capsule specimens (p < 0.05).In contrast, significantly more staphylococcus spp.Were found associated with nontumor capsule specimens compared with breast implant¿associated alcl specimens (p < 0.001).Bacterial biofilm was visualized both on scanning electron microscopy and fluorescent in situ hybridization.¿ cytological markers alk- and cd30+ have been reported.According to table 1 ¿clinical summary of breast implant¿associated alcl patients,¿ there was 1 case of alcl present in the ¿capsule.¿ article clarifies the ¿capsule¿ case as ¿one patient the diagnosis of breast implant¿associated alcl was an incidental finding while undergoing implant exchange for capsular contracture.¿ there is currently no way to determine which cases had tested negative for bacterial infection.This report will capture 1 case of alcl presented with ¿capsule,¿ represented by term code capsular contracture.

• Brand Name: UNK MAMMARY IMPLANT
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): UNKNOWN MANUFACTURER
• Manufacturer (Section G): UNKNOWN MANUFACTURER
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 6153118
• MDR Text Key: 61701316
• Report Number: 9617229-2016-00187
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P990074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK MAMMARY IMPLANT
• Date Manufacturer Received: 11/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention