MAUDE Adverse Event Report: ALLERGAN STYLE 110 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number 27-110361

Device Problems Folded (2630); No Apparent Adverse Event (3189)

Patient Problems Seroma (2069); Breast Mass (2439); Anaplastic Large Cell Lymphoma (3264)

Event Date 12/15/2008

Event Type  Injury  

Event Description

Additional info received from a literature article, "anaplastic large cell lymphoma and breast implants: five australian cases published in the plastic and reconstructive surgery on (b)(6) 2012 pg 610e-617e.Within the article the author describes a (b)(6) who underwent bilateral augmentation with 110-360 inamed textured round devices via inframammary, into a sub glandular pocket.In (b)(6) 2008, the pt presented with spontaneous left breast swelling, although she was with on fever and mild discomfort.The left breast was diffusely swollen.The pt had a normal mammo in 2008 and in 2009 ultrasound revealed a seroma.A ct scan showed an "infolding of the implant between 7 and 9 o'clock, with an apparent mass with slightly increased density".In (b)(6) 2009, surgery was planned to remove the presumed ruptured implant.At the time of surgery, a straw colored seroma of 200cc was found.The implant was intact.Within the capsule there were two areas of granulomatous tissue and thick mass inferomedially.The capsule and mass were sent to microbiology, culture, and histopathology."the lymphoid cells were highly atypical, showing enlarged and irregularly configured nuclei.Immunohistochemical analysis showed cd30 +, alk-, b-cell marker negative, and t-cell marker partial and patchily-positive (cd3, cd43, cd45ro, and cd5) tissue.The findings were consistent with localized form of systemic alcl, large t-cell lymphoma." the breast healed, but a recurrent mass appeared weeks later."staging ct of chest, abd, pelvis and pet scan showed no evidence of disease outside the breast.She underwent chemo with cyclophosphamide, doxorubicin, vincristine and prednisone in (b)(6) 2009, the mass failed to respond and progressed to a wound.The lymphoma metastasized to the thoracolumbar region and the right lung as seen in the (b)(6) 2009 pet scan.She was treated with radiation and a second round of chemo using gemcitabine, ifosfamide, and, vinorelbine.She responded well and underwent a bone marrow transplant in 12/2009.Two years after diagnosis, she remains in remission.This event was originally submitted via (b)(4) on (b)(4) 2011.

Manufacturer Narrative

(b)(4).Device labeling addresses the reported event of seroma as follows: the core study: 7 year adverse event rates: for primary augmentation pts, seroma rate= 1.6%.Primary reconstruction pts =1.0% (other complications).Swelling = 7.1%."after breast implant surgery the following may occur and/or persist, with varying intensity and/or for a varying length of time: hematoma/seroma" (allergan silicone labeling).Device labeling reviewed: there were no reported events of lymphoma/alcl, for pts in the core study, in the labeling for silicone implants.Silicone pt brochure: breast self-examinations.Following breast augmentation, you should continue to perform breast self-examination monthly.This may be more difficult with a breast implant in place.To continue to perform a monthly breast self examination efficiently, you should ask your surgeon to help you identify the difference between the implant and your breast tissue.Being able to identify the implant from breast tissue will decrease the necessity of excessive squeezing of the implant during examination.Any new lumps should be psy, as appropriate.If a biopsy is performed, be sure to inform the medical professional performing the biopsy that you have breast implants so that care will be taken to avoid injuring the implant.

Manufacturer Narrative

The event of anaplastic large cell lymphoma was initially reported via epsr on (b)(8) 2011, with the adverse event term code of cancer ar update to our safety database for this reported event notes that the term code has been changed from cancer to lymphoma-alcl due to increased specificity.Patient identifier "(b)(6)" relates to patient's record previously existing in easy track database.Current database.Patient identifier is pr "(b)(6)".Device labeling: 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.Calcium deposits can form in the tissue capsule surrounding the implant with symptoms that may include pain and firmness.Lymphadenopathy has also been reported in some women with implants.Use care in subsequent procedures such as open capsulotomy, breast pocket revision, hematoma/seroma aspiration, and biopsy/lumpectomy to avoid damage to the implant.Postoperative hematoma and seroma may be minimized by meticulous attention to hemostasis during surgery, and possibly also by postoperative use of a closed drainage system.Persistent, excessive bleeding must be controlled before implantation.Any postoperative evacuation of hematoma or seroma must be conducted with care to avoid breast implant contamination or damage from sharp instruments.A recent report indicates that larger sized implants (>350cc) may increase the risk of developing complications such as implant extrusion, hematoma, infection, palpable implant folds, and visible skin wrinkling requiring surgical intervention to correct these complications.

Event Description

Company representative received information from a healthcare professional that one of his patients presented with anaplastic t cell lymphoma.Additional information from a "anaplastic large cell lymphoma and breast implants.Five australian cases" by kim 0 taylor d s and howard webster published in the plastic and reconstructive surgery april 2012 pg 610e-617e journal states, "the patient presented with spontaneous left breast swelling.The left breast was diffusely swollen.An ultrasound showed that the margins of the left implant were irregular with adjacent fluid.A computed tomography chest can scan showed an infolding of the implant between 7 and 9 o'clock, with an apparent mass with slightly increased density.At the time of surgery, a straw colored seroma of 200cc was found.The implant was intact within the capsule there were two areas of granulomatous tissue and thick mass inferomedially.The capsule and mass were sent to microbiology, culture, and histopathology.The lymphoid cells were highly atypical, showing enlarged and irregularly configured nuclei immunohistochemical analysis showed cd30 +, alk-, b-cell marker negative, and t-cell marker partial and patchily-positive (cd3, cd43, cd45ro, and cd5) tissue.The findings were consistent with localized form of systemic alcl, large t-cell lymphoma.".

Event Description

Company representative received information from a healthcare professional that one of his patients presented with anaplastic t cell lymphoma.Additional information from a "anaplastic large cell lymphoma and breast implants: five australian cases¿ by kim o taylor and howard webster.Published in the plastic and reconstructive surgery april 2012 pg 610e-617e.Journal states, "the patient presented with spontaneous left breast swelling.The left breast was diffusely swollen.An ultrasound showed that the margins of the left implant were irregular with adjacent fluid.A computed tomography chest can scan showed an infolding of the implant between 7 and 9 o¿clock, with an apparent mass with slightly increased density.At the time of surgery, a straw colored seroma of 200cc was found.The implant was intact.Within the capsule there were two areas of granulomatous tissue and thick mass inferomedially.The capsule and mass were sent to microbiology, culture, and histopathology.The lymphoid cells were highly atypical, showing enlarged and irregularly configured nuclei.Immunohistochemical analysis showed cd30 +, alk-, b-cell marker negative, and t-cell marker partial and patchily-positive (cd3, cd43, cd45ro, and cd5) tissue.The findings were consistent with localized form of systemic alcl, large t-cell lymphoma.".

Manufacturer Narrative

(b)(4).

Event Description

Allergan is submitting this follow-up mdr in accordance with 21 cfr 803 following the recall of biocell textured breast implants and tissue expanders in relation to the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (bia-alcl).

• Brand Name: STYLE 110 SILICONE GEL FILLED BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN; arklow, county, wicklow ; EI
• Manufacturer (Section G): ARKLOW; kilbride industrial estate; arklow, county wicklow ; EI
• Manufacturer Contact: michelle burgess ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 3883642
• MDR Text Key: 4565748
• Report Number: 2024601-2012-00364
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P020056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2010
• Device Catalogue Number: 27-110361
• Device Lot Number: 1148082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2005
• 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
• Treatment: NO INFO ; NO INFO
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female