MAUDE Adverse Event Report: SIENTRA SIENTRA BREAST IMPLANT; BRAST IMPLANT

Model Number 10512-550-MP

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Fatigue (1849); Fever (1858); Unspecified Infection (1930); Pain (1994); Chills (2191); Dizziness (2194); Discharge (2225)

Event Date 05/28/2015

Event Type  Injury  

Event Description

Had a breast implant surgery in (b)(6) 2015.It was to replace my older implants in which i had no problems.This was just a routine breast revision surgery.The implants were made by sientra.At 2 weeks after surgery got very ill, dizziness, fever, chills, extreme fatigues, loss of appetite, and pain on my left side.It went undiagnosed for another week, they thought i had contracted the flu.The plastic surgeon referred me to an infectious disease dr.Exactly one month after surgery, i started iv antibiotics under care of.Begun a 4 week round of vancomycin and azithromycin.Infection levels dropped some, still very ill and skin on breast was redder, more hard, and very painful.At week 8, noticed some discharge from nipple where the stitches had been.I went to plastic surgeon, he made a small hole, fluid came gushing out.He said the implant was on top and was visible, rather than under the muscle; it was pushing its' way out.Scheduled the surgery of explant of the left side in which i had the infection.My right brest appeared fine, no pain or redness, stitches normal on the right side.In doing a culture of the tissue, it was determined the infection was caused by mycobacterium fortuitum.When the infectious disease dr.Informed me of what this was, he said it was very rare in the us.He had only seen this infection once before, 10 yrs.Prior on a breast implant surgery on someone who had been in the marines.I then started the antibiotic clarithromycin for another 4 weeks.The dr.Has felt that a protocol somewhere was missed and believed was on the implant to start.In gathering second opinions, as i was concerned, going back to the original surgeon, numerous comments from plastic surgeons were they assumed i had gone out of the country to have my surgery.I have never been out of the country and had surgery in (b)(6).I contacted the county health dept., but they don't keep record or report this type of bacteria i was told.Currently have disfigured left side due to lots of tissue damage and lots of scar tissue.Sientra - left side (infected side) (b)(4), serial #(b)(4) smooth round, mp on (b)(6), was at a plastic surgeons office for a consultation.He mentioned he hoped that sientra implants would be back available in the spring of 2016 to his nurse.This made me curious as i had not heard they were off market.Saw an article from (b)(6) 2015, that there were some problems with plant in (b)(6).I thought it was important to report since the infection may have come from this plant; would not want people to go through the last few months of what i did and the reconstructive surgery yet to come.I have asked the original doctor a few times if he reports to sientra the lot number as i was curious if anyone else experienced these problems, he said no, as if it wasn't something to report to them.I went online to the sientra website in (b)(6) to see if they spoke of any problems and there wasn't a recall or further info.

• Brand Name: SIENTRA BREAST IMPLANT
• Type of Device: BRAST IMPLANT
• Manufacturer (Section D): SIENTRA
• MDR Report Key: 5277099
• MDR Text Key: 33181451
• Report Number: MW5058403
• Device Sequence Number: 1
• Product Code: FTR
• 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: 12/06/2015

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
• Device Operator: No Information
• Device Model Number: 10512-550-MP
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 47 YR
• Patient Weight: 59