MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS ELEVATE POSTERIOR APICAL REPAIR WITH PLASTIC TRANSVAGINAL MESH; MESH SURGICAL

Device Problems Material Fragmentation (1261); Patient-Device Incompatibility (2682)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Muscle Spasm(s) (1966); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Urinary Tract Infection (2120); Loss of Vision (2139); Depression (2361); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 04/28/2016

Event Type  Injury  

Event Description

I used to be a positive woman with energy.But when i was (b)(6) years old in (b)(6) 2016, i had an ams elevate transvaginal mesh implant surgery hoping to relieve the discomfort of a rectal prolapse.Since the mesh implant, have had intense severe pelvic pain and sciatica in my left side, a rectal organ perforation, rectum bleeding, rectal pain dyspareunia and anal spasms.The pain i've endured has caused so much stress that i had an eye stroke diagnosed in (b)(6) 2018.I lost my vision permanently in my left eye.I don't have a normal life anymore.I am limited, my capacity of movement and energy are gone.I am unable to be a good mother and grandmother; and i also cannot work because of the intense pain i feel all the time.I had been taking prescribed pain killers, like oxycodone and percocet since the mesh implant, making me feel drugged and dizzy.Nevertheless, the pain was still there.I have been ignored by numerous doctors, which has been frustrating and exhausting.I don't like having to visit so many doctors and i have risked and am risking my life in each surgery.Nevertheless, i struggle to find a doctor that will take this intense pain away.In the last two years, i have had five surgeries after the ams transvaginal mesh implant, which was performed at (b)(6) in (b)(6) on (b)(6) 2016: (b)(6) 2017 - surgery, rectal intussusception rectocele starr - dr.(b)(6) - (b)(6), (b)(6), (b)(6) 2017 - surgery, granuloma dissection removal over the tip of the propylene auto-fixation to sacrospinous - dr.(b)(6) - (b)(6) - (b)(6), (b)(6) 2017 - surgery, drainage removal correction of orientation of the small arm mesh in the left vaginal depth section - dr.(b)(6), (b)(6) - (b)(6), (b)(6) 2018 - surgery, vaginal mesh kit removal, nerve repair with allograft - dr.(b)(6) md-urogynecologist - (b)(6), (b)(6).On (b)(6) 2018 - surgery- anorectal; dr (b)(6) removed foreign body.Finally i found a dr who was compassionate enough to hear what i have been going through, giving me hope to take this pain away.Dr (b)(6) md urogynecologist in (b)(6).He even offered to operate me without any charge, he really takes "the hippocratic oath" very seriously.Dr (b)(6) performed this last surgery, mesh removal, in (b)(6) 2018 at (b)(6) in (b)(6).I had an appt on (b)(6) 2018, with dr (b)(6), where he told me that i may have some small pieces of mesh leftovers in my pelvic and rectal area, that is why he referred me to gi.Sent me to a gi to do an auscultation via endoscopy.Dr (b)(6) said i have a permanent pain nerve damage.I will probably need to have a second-stage surgery, since i still have these pains: pelvic and perineal pain; chronic sciatica nerve damage, freezing pain travels from my lower back to my left side, leg and foot, dyspareunia pain during sexual intercourse dyschezia difficult and painful evacuation of feces from the rectum.Rectal bleeding, psychological distress and depression, anal spasms, eroding mesh into my rectum, urinary track infections.I am trying to find a way to take this psychological and physical pain away from me.But i can't because i will have to deal with medical issues the rest of my life and the risk of dying from this implant.I deserve a good quality of life.My body has been used as a guinea pig, as an experiment, without my consent by ams who sells a defective product.The ams graft elevate darts polypropylene mesh is a dangerous product made of petroleum-based plastic.The mesh erodes, breaking into small pieces that can cut and perforate the vagina, bladder, and bowels.It has also been reported to shrink, causing pain, damage, and infection to surrounding health tissue.It is not safe to be inserted a plastic mesh into the human body as a permanent implant.(b)(6).

• Brand Name: AMS ELEVATE POSTERIOR APICAL REPAIR WITH PLASTIC TRANSVAGINAL MESH
• Type of Device: MESH SURGICAL
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.
• MDR Report Key: 7717936
• MDR Text Key: 115187521
• Report Number: MW5078585
• Device Sequence Number: 1
• Product Code: FTM
• 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: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 57 YR
• Patient Weight: 59