• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR CORPORATION MENTOR'S BECKER SPECTRUM SALINE FILLED/SILICONE OUTER SHELL PROSTHESIS, BREAST, INFLATABLE, INTERNAL SALINE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MENTOR CORPORATION MENTOR'S BECKER SPECTRUM SALINE FILLED/SILICONE OUTER SHELL PROSTHESIS, BREAST, INFLATABLE, INTERNAL SALINE Back to Search Results
Event Date 06/01/2001
Event Type  Injury  
Event Description

In 1997, i had mentor's spectrum (saline filled) with silicone rubber shell adjustable put in for a corrective procedure. I was never explained that i was to be in clinical trials. I was told by my surgeon that since silicone was banned that i would need special approval to get these implants. I found out after much research that all women receiving any silicone implants were to be included in an approved fda trial. I was a part of the (b)(6). Mentor and their irb did not do any f/u with me although i worked on the same street as mentor and i did further charity work with the surgeon through my companies devices we donated. Never was i contacted for any f/u. My surgeon passed suddenly in 2003. In 2002 i began having health problems. Skin rashes, heart palpitations. I was diagnosed with supra ventricular tachycardia and placed on medication. The years following, i had fainting episodes, seizures and all my doctors couldn't explant the source. I was diagnosed in 2006 with sle (lupus). I had hyperthyroidism, hypothyroidism, hair loss raynaud's disease. Skin wound healing problems, bleeding disorder called von willebrand's and severe allergic reactions, which caused me to be on life support and no other cause. I have mental fog, inability to regulate my body heat, poor skin coloration from bad circulation. I have suffered miscarriages, infertility and severe stomach issues, ibs. I have seen many doctors during these last years and no one ever could find a source. They all said it was most likely lupus and left it at that. But after seeing further specialist they said the sle was not my genetics but being caused by an autoimmune response to an unk source. With joint pain, numbness in feet and hands. Blurred vision and overall exhaustion. I have felt as if i was dying. My left implant ruptured 2 weeks ago. I contacted mentor to ask about my warranty and was helped by a supervisor named (b)(4). He was able to locate me by my name and dob, locating my implants and told me to find a surgeon and they would send his replacement implants. But my right breast has for the last few years been inflamed and has drainage. It is hard and painful. The valves on the implants were left in and should have been removed after 6 months post-op. I also located documents for mentors pma of device p990075 and were they used the studies from (b)(6) to gain approval for their pma. The fda allowed their pma with the conditions to add the (b)(6) into the post-approval study which was a 10 year f/u mentor stated to the fda that they attempted to contact and mail enrollment packets to these women but couldn't locate the majority despite the data base they had and was part of the fda rules to save each device and the person receiving them. The fda under the rules of conditions for approval, made mentor do a more aggressive search using the 411 databases. (b)(6) address change datasheet with (b)(6). I was never contacted and i was more than easy to find. I hadn't changed my address in years. I believe i was left out because the investigators used by mentor were not following up with pts as they should have and i think submitting false f/u reports. Now i contacted mentor a few days ago to speak with mr. (b)(4), as i had previously asked who would help me cover the new surgeons expenses, only to find mr (b)(4) was unavailable and the new supervisor couldn't locate me like mr. (b)(4) had been able to. Mr. (b)(4) had requested me to write an email, stating my health issues, and the need for help to get the ruptured implant out and because i was "unique out of the box situation" he would be forwarding it to mentor legals department to see what they are willing to do. Now i see it because i was part of these studies and not f/u with. I believe these implants have made me gravely ill and mentor is blocking me in receiving proper treatment.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMENTOR'S BECKER SPECTRUM SALINE FILLED/SILICONE OUTER SHELL
Type of DevicePROSTHESIS, BREAST, INFLATABLE, INTERNAL SALINE
Manufacturer (Section D)
MENTOR CORPORATION
MDR Report Key7009617
Report NumberMW5073174
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 11/05/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received11/08/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/08/2017 Patient Sequence Number: 1
-
-