MAUDE Adverse Event Report: MENTOR, JOHNSON AND JOHNSON MENTOR MEMORY SILICONE; BREAST IMPLANTS

Device Problems Crack (1135); Material Rupture (1546); Split (2537)

Patient Problems Bacterial Infection (1735); Bruise/Contusion (1754); Capsular Contracture (1761); Diarrhea (1811); Edema (1820); Fatigue (1849); Fever (1858); Headache (1880); Hematoma (1884); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Memory Loss/Impairment (1958); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Swelling (2091); Tingling (2171); Chills (2191); Malaise (2359); Depression (2361); Numbness (2415); Sweating (2444); Weight Changes (2607)

Event Date 07/14/2017

Event Type  Injury  

Event Description

Breast cancer in 2000, so i chose reconstruction with saline implants.Within several months i developed capsular contracture in r breast.Due to length of initial surgery as well as length of hospitalization, i chose to wait.In 2006, contacted my plastic surgeon and was told fda had approved a silicone implant for breast cancer patients, so i met with a mentor representative that explained the study i would be required to participate in if i chose these specific implants.I actually held the implant and was assured the silicone would not leak out and if implant were punctured, the silicone would remain inside implant.I had these mentor silicone implants placed in 2007.In 2012 while leaning over the side of tub, i heard a pop, experienced a sharp shooting pain that went straight thru my left breast.I experienced horrific pain, consulted with pcp who ordered x-rays that showed no rupture.Pain persisted for months but eased in time.Within a year, i began to experience headaches, fatigue, chronic joint pain in left side of neck, shoulder, hip, knee, brain fog.Weight began to plummet, as did blood pressure and just all over general malaise.In 2017, i chose to have implants removed.Once left breast was opened, implant was ruptured and silicone had settled into the fascia going completely underneath my arm pit and almost to my back.Surgery lasted longer than expected due to the difficulty of removing the silicone.I was sent home and within 2 days i began hemorrhaging from left breast.Was rushed to surgery, large hematoma was removed and hospitalised for several days.Released and left breast began to swell, i ran a fever, chills, severe headache behind my eyes, nausea, fever.Rushed to surgery for third time.Left breast had infection both under muscle and within the breast cavity, so implant was removed.Cultures were done, idc was called in and i had pseudomonas aeruginosa and serratia marcescens.I was given iv cipro for several days.I suffered from chills, hallucinations, elevated blood pressure, fatigue and diarrhea.Released from hospital after 5 days.As of today, (b)(6) 2017, i'm taking cipro 500 mg twice daily, drain is still intact, takes me over 2 hours to bathe, dry my hair and dress, because i'm fatigued.Urine test show protein, my legs, ankles and feet are swelling, still experiencing pain in left wound, hard round know has formed in the center, some swelling remains, as does pain.Wound is not healing properly.Plastic surgeon does not know if or when surgical correction can take place.Chronic pain, chronic fatigue, cognitive dysfunction (brain fog, difficulty concentrating, word retrieval, memory loss, difficulty processing information), muscle aches, pains, and general weakness, joint pain, dry itchy eyes, easy bruising, loss of sex drive, inability to sexually perform, shortness of breath, night sweats, hormonal imbalances, tingling and numbness in arms, hands and fingers, cold hands and feet, metallic taste in mouth, nail cracking, splitting, no growth, skin freckling, increase in papules, edema, decline in vision, digestive and gastric issues, throat clearing, difficulty swallowing and choking feeling, anxiety, depression, panic attacks.

• Brand Name: MENTOR MEMORY SILICONE
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR, JOHNSON AND JOHNSON
• MDR Report Key: 6794136
• MDR Text Key: 82814951
• Report Number: MW5071574
• Device Sequence Number: 1
• Product Code: FTR
• 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: 08/11/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 56 YR
• Patient Weight: 114