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

Catalog Number	SRX-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Seroma (2069); Tingling (2171); Lymphoma (3263)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information contained in this report was previously submitted through psr on 24/jul/2017, 23/oct/2017, and 22/jan/2018.In response to fda report number mw5074273.(b)(4).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 physician regarding the event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformances noted.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 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.Infection: 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.Seroma: 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.Rupture: breast implants are not lifetime devices.Breast implants rupture when the shell develops a tear or hole.Ruptures can occur at any time after implantation, but they are more likely to occur the longer the implant is implanted.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.Silicone gel-filled implant ruptures are most often silent.This means that most of the time neither you nor your patient will know if the implant has a tear or hole in the shell.Mri examination is currently the best method to screen for rupture.Sometimes there are symptoms associated with gel implant rupture.These symptoms include hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning, and hardening of the breast.When mri signs of rupture are found (such as subcapsular lines, characteristic folded wavy lines, teardrop sign, keyhole sign, noose sign), or if there are signs or symptoms of rupture, you should remove the implant and any gel you determine your patient has, with or without replacement of the implant.It also may be necessary to remove the tissue capsule.There are also consequences of rupture.If rupture occurs, silicone gel may either remain within the scar tissue capsule surrounding the implant (intracapsular rupture), move outside the capsule (extracapsular rupture), or move outside the breast (gel migration).There is also a possibility that rupture may progress from intracapsular to extracapsular and beyond.".
Event or Problem Description
Patient reported 8 ambulance episodes following implant surgery and 6 weeks of being gravely ill.Patient reported contamination.Patient also reported metallic taste in mouth, swollen stomach, fluid swelling, massive pain in both breasts, seroma fluid buildup, joint pan in ligaments of legs, toxic shock, blurry vision, extreme exhaustion, fatigue, shooting pain in legs, numbness in arms, shoulder pain, difficulty swallowing, fever/chills, difficulty concentrating, and confusion.Patient also stated that [patient] was informed that [patient] had a breast abscess, contamination, and bacteria staph and sepsis blood poisoning.Patient also reported getting mrsa and another emergency a month later for drainage of infection.Patient stated that [patient] laid in bed for 5 months going back and forth to wound burn unit.Patient additionally reported being treated for alcl.Pathological markers confirming alcl have not been received.Physician has not confirmed.This record is for the left side.See mfr # 9617229-2018-00892 for the right side.
Additional Manufacturer Narrative
This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Patient additionally reported right side wound dehiscence.

• Brand Name: INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 7276678
• Report Number: 9617229-2018-00891
• Device Sequence Number: 2379121
• Product Code: FTR
• UDI-Device Identifier: 10888628007437
• UDI-Public: 10888628007437
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2020
• Device Catalogue Number: SRX-200
• Device Lot Number: 2806243
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention