MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) UNK TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number UNK TISSUE EXPANDER

Device Problem No Apparent Adverse Event (3189)

Patient Problem Unspecified Infection (1930)

Event Date 06/10/2016

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to the fda on 09/06/2016.Article citation: ¿salvaging the infected breast tissue expander: a standardized multidisciplinary approach,¿ george m.Viola, md, mph, jesse c.Selber, md, melissa crosby, md, issam i.Raad, md, charles e.Butler, md, mark t.Villa, md, steven j.Kronowitz, md, mark w.Clemens, md, patrick garvey, md, wei yang, md, and donald p.Baumann, md, prs global open, 2016 pp.1-11.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 has been requested from the reporter regarding if the event of infection was caused by or contributed to an allergan device, which side infection occurred on, product information, explant date and surgeon for devices that were removed, and if those explanted devices would be returned.No additional information is available at this time.Device labeling: the following is a list of potential adverse events that may occur with breast implant surgery.The risks include: implant deflation/leakage, additional surgery, capsular contracture, infection, toxic shock syndrome, necrosis, hematoma, seroma, extrusion, breast pain, changes in nipple sensation, changes in breast sensation, dissatisfaction with cosmetic results (wrinkling, folding, displacement, asymmetry, palpability, visibility, ptosis, sloshing), calcific deposits, irritation/inflammation, delayed wound healing, hypertrophic scarring, breast tissue atrophy/chest wall deformity, difficulty/inability in breast feeding, and inability to adequately visualize breast lesions with mammography.In addition to these potential adverse events, there have been concerns with certain systemic diseases.Pre-existing infections not resolved before tissue expander placement may increase the risk of periprosthetic infection.Infection is an inherent risk following any type of invasive surgery, and may occur during the tissue expansion process.Patients who present with wound dehiscence, tissue erosion, ischemia or necrosis, and patients undergoing immediate breast reconstruction run an increased risk of periprosthetic infection.Signs of acute infection reported in association with tissue expanders include erythema, tenderness, fluid accumulation, pain and fever.Erythema may also occur as a normal response to expansion.Aspiration to differentiate between this type of erythema and erythema as a sign of early infection is a recognized precaution.Research identifies staphylococcus and pseudomonas organisms in association with infection around tissue expanders.Escherichia and streptococcus organisms have also been noted in association with tissue expanders in the lower extremities.Infection may occur at any time after surgery, and may compromise the expansion process.Capsular contracture may be related to infection in the area surrounding the implant.Postoperative infections should be treated aggressively according to standard medical practices to avoid more serious complications.Infection that is unresponsive to treatment or necrotizing infection may require premature breast tissue expander removal.In rare instances, acute infection may occur in a breast with implants.The signs of acute infection include erythema, tenderness, fluid accumulation, pain, and fever.Very rarely, toxic shock syndrome, a potentially life-threatening condition, has been reported in women after breast implant surgery.It is characterized by symptoms that occur suddenly and include high fever (102°f, 38.8°c or higher), vomiting, diarrhea, a sunburn-like rash, red eyes, dizziness, lightheadedness, muscle aches, and drops in blood pressure, which may cause fainting.Patients should be advised to contact a physician immediately for diagnosis and treatment for any of these symptoms.

Event Description

Reported events of 8 patients with ¿infection¿ for an unknown allergan tissue expander were found within the journal article ¿salvaging the infected breast tissue expander: a standardized multidisciplinary approach,¿ prs global open, 2016 pp.1-11.Patients were either treated with ¿oral antimicrobial regimen¿, further described as ¿minocycline, ciprofloxacin, and rifampin,¿ or ¿were stated on an intravenous regimen.¿ the most common ¿combined intravenous and oral regimen was daptomycin, cefepime, and rifampin¿, or ¿daptomycin, ciprofloxacin, and rifampin.¿ the method of treatment was determined by the severity of the patient¿s infection.It is not specified which treatment was provided to the patients implanted with an allergan device, but as treatment was provided for all patients enrolled within the review, the methods of treatment are captured here.The 8 patients mentioned did not have their devices explanted as part of treatment.The affected side was not specified; this medwatch represents the left side.See mfr # 9617229-2016-00126 for the right side.

• Brand Name: UNK TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 5929019
• MDR Text Key: 53946083
• Report Number: 9617229-2016-00125
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK TISSUE EXPANDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR