MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS INC. AMS - BLADDER - PELVIC MESH; MESH,SURGICAL,SYNTHETIC,UROGYNECOLOGIC,FOR STRESS URINARY INCONTINENCE,RETROPUBIC OR TRANSOBTURATOR

Device Problem Defective Component (2292)

Patient Problem Death (1802)

Event Date 03/06/2019

Event Type  Death  

Event Description

Maybe you are aware of the (b)(6) dollar ams/endo mesh settlement? click link for info: (b)(4)/ it should be of no surprise to you that endo / ams would like to deny that the defective products implanted into my mother is not the cause of her death.I believe differently.See if they deny the medical bills - they are not required to pay for a wrongful death settlement nor my mom's (b)(6) medical bill.So who pays the medical bills for the reckless behavior of endo / ams - for the women in (b)(6) on (b)(6)? you guessed it - (b)(6).Please see the letter / email i sent in yesterday to the ams / endo settlement appeals master.It is my hope that (b)(6) would partner with me to have an autopsy completed on my mother.If a dr that specializes in bladder / pelvic mesh surgery could accompany the medical examiners to make a proper conclusion on my mother's death, this would be most useful.Why should tax payers pay for pharmaceutical companies errors of putting defective products in the commerce stream and then allow drs who are implanting these defective devices into women all across our nation? why should they get off with a mere slap on the wrist.What's (b)(6)dollars really to a company that makes (b)(6) a year? i pray for all the women and their families, but there is one casualty that i will not allow ams / endo to easily forget, that is my mother - (b)(6).Please fight with me to ensure that american medical systems / endo pay for the medical bills, so the great state of (b)(6) does not have to.Let's hold them accountable for my mom and her death.Hello, my name is (b)(6), i am one of 8 children born to the late (b)(6).My mother passed away on (b)(6) 2019.I have been advised against pursuing a wrongful death suit against american medical systems / endo.I am told it is too expensive and the case could take years before it could settle.Several attorneys have stated they have spent 10 years and over (b)(6) dollars on these mesh cases for their own clients.To that end, i do wish to appeal to the settlement master and request a re-review of the amount offered to my mother ((b)(6)).The amount ams / endo offered for her settlement was a meager (b)(6).This amount is unequivocally unacceptable and to be candid very insulting and condescending.I suspect the lawyers benefited more than the women, so no skin off their backs if ams / endo agree to pay these poor women as little as they possibly can.What poor (b)(6) can afford to take on a (b)(6) dollar.

• Brand Name: AMS - BLADDER - PELVIC MESH
• Type of Device: MESH,SURGICAL,SYNTHETIC,UROGYNECOLOGIC,FOR STRESS URINARY INCONTINENCE,RETROPUBIC OR TRANSOBTURATOR
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS INC.
• MDR Report Key: 8473584
• MDR Text Key: 140728939
• Report Number: MW5085482
• Device Sequence Number: 0
• Product Code: OTN
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/06/2019
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 76 YR
• Patient Weight: 45