MAUDE Adverse Event Report: Allergan (Costa Rica) Style 68 Saline Filled Breast Implant; prosthesis, breast, inflatable, internal, saline

Catalog Number	68HP-700
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swollen Lymph Nodes/Glands (4432)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "recalled certain biocell textured breast implant and health concerns".Later patient reported "swollen/enlarged underarm lymph nodes, neck pain, back pain, significant muscle aches, joint pain, generalized body aches, fatigue - no device related, brain fog, hair loss, skin changes, anxiety, depression, mood swings, difficulty sleeping - no device related, digestive problems/changes in digestion".This record is for the left side.Device remains implanted.
Additional Manufacturer Narrative
Clarification for b3: this is a partial date of event for report "2024".Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event of "lymphadenopathy" is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Reason for reoperation: lymphadenopathy.

• Brand Name: Style 68 Saline Filled Breast Implant
• Common Device Name: prosthesis, breast, inflatable, internal, saline
• Manufacturer (Section D): Allergan (Costa Rica); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): Allergan (Costa Rica); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; +1(847)936-6324
• MDR Report Key: 50510512
• Report Number: 9617229-2026-16456
• Device Sequence Number: 21510251
• Product Code: FWM
• UDI-Device Identifier: 10888628000483
• UDI-Public: (01)10888628000483(17)180811
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: 08/11/2018
• Device Catalogue Number: 68HP-700
• Device Lot Number: 2652159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/16/2026
• Initial Report FDA Received Date: 08/30/2026
• Date Device Manufactured: 09/11/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Sex: Female