MAUDE Adverse Event Report: ETHICON GYNECARE PROLIFT BLADDER SLING

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Cyst(s) (1800); Purulent Discharge (1812); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Pain (1994); Complaint, Ill-Defined (2331); Inadequate Pain Relief (2388)

Event Date 03/23/2015

Event Type  Injury  

Event Description

On (b)(6) 2007, i had a transvaginal rectocele repair and pph stapled hemorrhoidectomy.Diagnosis:rectal prolapse, rectocele, and a internal hemorrhoid.Dr (b)(6) in (b)(6), at the medical center of (b)(6) did these surgeries.I was supposed to be in the hosp 1-2 days.I was hospitalized from (b)(6).They almost killed me with that stapler.Even though i was supposed to be asleep, i could feel it firing inside my rectum.I could hear the doctors and nurses talking about the malfunction after the surgery.I was in severe pain for 3 days, stayed in some degree of pain for months afterwards.I required 2 pints of blood, i knew that my surgery was a complete flop from day one.I never had a normal bm after that horrific surgery, pus ran from my rectum constantly for 2 years.I could not sit down easily for at least a year.I got huge cysts inside my body, when they burst the pus was bright orange, smelled like a dead animal so it had to be rotting flesh somewhere.I called dr (b)(6) so many times, i went to see him several times, he treats me so bad.He denies everything.Half of my medical records are missing from the medical center of (b)(6) where i had my surgeries.After finally going to other doctors, i am diagnosed with having all the same problems that i had before only my problems are much worse and i am 8 years older.In (b)(6), i will fly to (b)(6) to have total reconstruction of my entire pelvic floor, repairing my rectocele, prolapse, and to remove numerous pieces of mesh out of my rectum and vagina.I also have several devices that have migrated that have to be removed.I have some sort of device inside my bowel, i am one very sick woman who can not afford to be sick.It's a shame that this has been so hard for me to uncover, all i wanted was a regular surgery, the kind of surgery that has worked so well for decades.I went to the hosp thinking that this was going to fix me, what it did was destroy my life basically.I am going to have total reconstruction surgery again, remove all of these plastic sutures and devices, miss months of work, not sure if i will ever be able to work or sit down again.I have a (b)(6) non verbal son with severe autism who needs me to live to be an old woman and help take care of him (i'm scared to death to tell you the truth).It's really sad that i had to take my health in my own hands, go to another state to try to save my own life.Gynecare prolift bladder sling, also has to come out because it is embedded inside my colon.

• Brand Name: GYNECARE PROLIFT BLADDER SLING
• Type of Device: BLADDER SLING
• Manufacturer (Section D): ETHICON
• MDR Report Key: 4664729
• MDR Text Key: 5609318
• Report Number: MW5041890
• Device Sequence Number: 4
• Product Code: OTP
• 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: 03/30/2015
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2015
• Patient Sequence Number: 1
• Treatment: SENEKOT LAXATIVES AT NIGHT; HERBAL LAXATIVES
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 47 YR
• Patient Weight: 64