MAUDE Adverse Event Report: UNKNOWN MANUFACTURER UNK TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number UNK TISSUE EXPANDER

Device Problem No Apparent Adverse Event (3189)

Patient Problems Cellulitis (1768); Unspecified Infection (1930)

Event Date 06/15/2016

Event Type  Injury  

Manufacturer Narrative

Medwatch submitted to the fda on 09/06/2016.Article citation: ¿refinements in the techniques of 2-stage breast reconstruction,¿ matthew d.Freeman, bs, rahul vemula, md, rahul rao, ma, tim s.Matatov, md, amy l.Strong, phd, mph, ravi tandon, md, abigail e.Chaffin, md, and david a.Jansen, md, facs, annals of plastic surgery, vol.76, supplement 4, june 2016, pp.S304-s311.Further information from the senior author, dr.David a.Jansen, regarding the number of allergan devices used in the study, the causality of the reported adverse events, product information, date of explant surgery, name of explant surgeon, and if the explanted devices will be returned was requested.No additional information will be provided as further follow up is not possible as the doctor is unavailable for additional questioning.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.Active infection anywhere in the body may increase risk of periprosthetic infection.Do not expose the tissue expander or injection needles to contaminants, which increase the risk of infection.Patients who present wound dehiscence, tissue erosion, ischemia or necrosis run an increased risk of periprosthetic infection.Measures to protect such areas from infection should be taken.Signs of acute infection reported in association with tissue expanders include, tenderness, fluid accumulation, pain and fever.Infection may compromise the expansion process.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 tissue expander removal.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 5 cases of ¿surgical site infection¿ for patients implanted with tissue expanders and acellular dermal matrix (adm) were found within the journal article ¿refinements in the techniques of 2-stage breast reconstruction¿, annals of plastic surgery, vol.76, supplement 4, 2016, pp.S304-s311.Additionally, the article states a defining point of infection is the involvement of ¿cellulitis with an intact wound.¿ the authors indicated that the patient¿s tissue expanders were ¿allergan and mentor.¿ the author did not explicitly state how many patients were implanted with either an allergan or a mentor device.¿antimicrobial therapy¿ was provided to treat cellulitis and infection.As most patients within the article had devices explanted, the devices are assumed explanted.The manufacturer is unknown.The affected side was not provided.

• Brand Name: UNK TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• 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: 5928595
• MDR Text Key: 53926068
• Report Number: 9617229-2016-00117
• 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: Physician
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• 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
• Treatment: SURGICAL SCAFFOLD - NON-ALLERGAN
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR