MAUDE Adverse Event Report:; EXPANDER, SKIN, INFLATABLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Reaction (1733); Fatigue (1849); Unspecified Infection (1930); Pain (1994); Arthralgia (2355)

Event Type  Injury  

Event Description

On (b)(6) 2017- bilateral mastectomy due to breast cancer; developed lymphedema requiring continued weekly therapy; late (b)(6)-(b)(6) lost overall vitality and suffered life threatening condition (unsubstantiated as infection, i suspect it was an adverse autoimmune response to silicone implants); (b)(6) left expander was replaced; was given 7 1/2 weeks of massive doses of iv antibiotics even though blood tests did not actually show evidence of infection; no culture was ever performed to identify cause of "infection"; (b)(6)-(b)(6) continued to suffer debilitation and pain, felt like i was constantly fighting a virus or infection; lymphedema did not improve; my doctor kept telling me there was no real problem with the implants; (b)(6) both expanders were replaced with permanent gel-filled silicone implants; (b)(6)-(b)(6) i continued to experience pain (not surgical pain - it was different), debilitation, and other adverse effects; had both implants removed on (b)(6) 2017.By (b)(6) i began to regain normal energy levels and an improved sense of well-being.Twelve days after surgery i still have some post-surgical pain but not anything like what i suffered with from (b)(6) to (b)(6).I believe my body reacted to the silicone material used in the initial expander implants as well as in the permanent implants.Wide-spread joint pain, unresolved lymphedema, localized sensation of ants crawling between the implants and pectoral muscles, loss of energy, constant feeling that my body was fighting something bad.I do not have identification data on the temporary expander implants.Beginning (b)(6) 2018 i began using cbd/thc edibles for pain management and sleep assist (legal in (b)(6) and i have obtained a medical marijuana card); i chose this option because nothing else was helping with the ongoing implant pain.There are distinctive differences between fibromyalgia pain, surgical pain, and the pain and illness caused by the silicone implants.I could tell the difference.

• Type of Device: EXPANDER, SKIN, INFLATABLE
• MDR Report Key: 8222227
• MDR Text Key: 132547065
• Report Number: MW5082870
• Device Sequence Number: 5
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/02/2019
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Weight: 75