MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALIGN® TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM - HALO

Catalog Number BRD500HL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Erosion (1750); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Headache (1880); Inflammation (1932); Pain (1994); Abnormal Vaginal Discharge (2123); Vomiting (2144); Burning Sensation (2146); Rupture (2208); Anxiety (2328); Discomfort (2330); Fungal Infection (2419); Choking (2464); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Cognitive Changes (2551); Confusion/ Disorientation (2553); Abdominal Distention (2601); Unspecified Immune System Problem (4435); Cramp(s) /Muscle Spasm(s) (4521); Localized Skin Lesion (4542); Skin Inflammation/ Irritation (4545)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

It was reported that patient during surgery prolapsed bladder sling.Patient was completely unaware that they had any type of sling other than the first one they had ever had, which was from the thigh of the cadaver using the muscle of a cadaver this surgery was in 2013 in surgery center.Patient did not know they had a mesh sling inside of them until they saw the urologist in 2019.In 2013, patient saw doctor as they were experienced stomach issues, horrific pains, and unexplained pain in their right lower back.Patient had not hurt themselves, anything.Patient had terrible unexplained gagging at times, vomiting if they even took a drink of water, choking, and would have to run to the sink when they laid down.After a few tests, doctor informed patient that their gallbladder had ruptured.Doctor asked patient if they had any signs, and patient explained the choking, vomiting, and other things.The start of many illnesses, hospital visits, and their body slowly deteriorating over these past years.Finding the mesh on 2019 was the last puzzle piece.Patient never felt the same after recovering from the second sling for their prolapsed bladder.Approximately six months later, patient started smelling the worst foul odor in their vagina.They could smell it just sitting or standing, it was not a urine smell, just the worst smell.Patient often went to the doctor and received the same diagnosis every time (bacterial vaginosis) they would call in an antibiotic and a cream.For the first few years, patient would go on the medication.It did nothing except give them a yeast infection.Patient have been sicked every day since doctor implanted a mesh knowing what it would do to them.Worst of all, they were not asking them or giving them a choice.Doctor and cr bard knew that the fda issued its first severe warnings in 2008 and 2011 just to confirm this was about the medical device.Doctor would have done that to their wife, mother.Sister, in 2012 six months before this patient surgery, doctor implanted with one of their mesh products.Cr bard (bard) withdrew its avaulta plus and align vaginal mesh from the market in (b)(6) 2012, weeks before losing a verdict to a woman who experienced complications from the device.The same thing happened with the horrific pain, being unable to sit, entertain anymore, and slowly but surely being able to go out.Patient body started giving them fatigue.Patient experienced lower back, groin area, would be in such pain.Patient started experienced extreme pain in their lower back, bringing them to their knees.Patient had a very high pain tolerance that has landed them in the emergency room and numerous hospitals stays with serious infections/surgeries throughout their life.It was at least a 15-18+ and always got them into trouble.Patient began experienced excruciating pain.Patient had slept funny and tweaked their back.Patient started experienced severe pain in their hip, groin, and leg.The pain became neverending.Patient had spent weeks, sometimes months, in such pain and fogginess.The mesh started destroying their life within six months of being implanted in 2013.Patient started gagging for months, choking, and throwing up, etc.And saw a surgeon to have some horrific hemorrhoids removed, and two days later, patient gallbladder burst.Patient gallbladder flaring six months after their mesh was the first of many things/illnesses that happened to them after the new mesh sling that they still were unaware was a mesh sling.Patient started having a horrific odor that doctors would prescribe, an antibiotic cream, and an antibiotic, which never disappeared by the end of 2013.Every doctor patient saw told them they had a vaginal discharge or a bacterial infection.Patient stomach started getting distended, the cramping would drop them to their knees and bring them to often tears many days when this happened.Patient tried holistic medications, and at night and during the day, they would like meloxicam, tramadol, oxycodone, etc.Patient finally got their medical cannabis card.They got relief from national products, which helped them get through the day and sleep through the night from the debilitating pain and inflammation with the emotional toll, physical toll, and robbed of their life since 2013.Patient would get such terrible bouts of pain, diarrhea, fatigue, and headaches, and they could not sit up and sleep and had it.Patient had their entire abdomen eroded, but their immune system has been compromised, not being able to fight off any infections, anything since doctor implanted the mesh sling, genuinely from the inside out.In 2014, patient started breaking out in sores all over their neck, head, face, back, arms, legs, basically everywhere.Patient had tests done, biopsies, and more meds, and it just worsened year after year.Patient remember going to a new doctor in 2018 as they had gotten a horrific case of shingles on their face and neck and had no idea as their body by this time was so plagued by sores everywhere, and they were so used to being in pain from the inside out and feeling like they were on fire.Doctor looked at patient, told them they had shingles and prescribed medication.

Event Description

It was reported that patient during surgery prolapsed bladder sling.Patient was completely unaware that they had any type of sling other than the first one they had ever had, which was from the thigh of the cadaver using the muscle of a cadaver this surgery was in 2013 in surgery center.Patient did not know they had a mesh sling inside of them until they saw the urologist in 2019.In 2013, patient saw doctor as they were experienced stomach issues, horrific pains, and unexplained pain in their right lower back.Patient had not hurt themselves, anything.Patient had terrible unexplained gagging at times, vomiting if they even took a drink of water, choking, and would have to run to the sink when they laid down.After a few tests, doctor informed patient that their gallbladder had ruptured.Doctor asked patient if they had any signs, and patient explained the choking, vomiting, and other things.The start of many illnesses, hospital visits, and their body slowly deteriorating over these past years.Finding the mesh on 2019 was the last puzzle piece.Patient never felt the same after recovering from the second sling for their prolapsed bladder.Approximately six months later, patient started smelling the worst foul odor in their vagina.They could smell it just sitting or standing, it was not a urine smell, just the worst smell.Patient often went to the doctor and received the same diagnosis every time (bacterial vaginosis) they would call in an antibiotic and a cream.For the first few years, patient would go on the medication.It did nothing except give them a yeast infection.Patient have been sicked every day since doctor implanted a mesh knowing what it would do to them.Worst of all, they were not asking them or giving them a choice.Doctor and cr bard knew that the fda issued its first severe warnings in 2008 and 2011 just to confirm this was about the medical device.Doctor would have done that to their wife, mother.Sister, in 2012 six months before this patient surgery, doctor implanted with one of their mesh products.Cr bard (bard) withdrew its avaulta plus and align vaginal mesh from the market in (b)(6) 2012, weeks before losing a verdict to a woman who experienced complications from the device.The same thing happened with the horrific pain, being unable to sit, entertain anymore, and slowly but surely being able to go out.Patient body started giving them fatigue.Patient experienced lower back, groin area, would be in such pain.Patient started experienced extreme pain in their lower back, bringing them to their knees.Patient had a very high pain tolerance that has landed them in the emergency room and numerous hospitals stays with serious infections/surgeries throughout their life.It was at least a 15-18+ and always got them into trouble.Patient began experienced excruciating pain.Patient had slept funny and tweaked their back.Patient started experienced severe pain in their hip, groin, and leg.The pain became neverending.Patient had spent weeks, sometimes months, in such pain and fogginess.The mesh started destroying their life within six months of being implanted in 2013.Patient started gagging for months, choking, and throwing up, etc.And saw a surgeon to have some horrific hemorrhoids removed, and two days later, patient gallbladder burst.Patient gallbladder flaring six months after their mesh was the first of many things/illnesses that happened to them after the new mesh sling that they still were unaware was a mesh sling.Patient started having a horrific odor that doctors would prescribe, an antibiotic cream, and an antibiotic, which never disappeared by the end of 2013.Every doctor patient saw told them they had a vaginal discharge or a bacterial infection.Patient stomach started getting distended, the cramping would drop them to their knees and bring them to often tears many days when this happened.Patient tried holistic medications, and at night and during the day, they would like meloxicam, tramadol, oxycodone, etc.Patient finally got their medical cannabis card.They got relief from national products, which helped them get through the day and sleep through the night from the debilitating pain and inflammation with the emotional toll, physical toll, and robbed of their life since 2013.Patient would get such terrible bouts of pain, diarrhea, fatigue, and headaches, and they could not sit up and sleep and had it.Patient had their entire abdomen eroded, but their immune system has been compromised, not being able to fight off any infections, anything since doctor implanted the mesh sling, genuinely from the inside out.In 2014, patient started breaking out in sores all over their neck, head, face, back, arms, legs, basically everywhere.Patient had tests done, biopsies, and more meds, and it just worsened year after year.Patient remember going to a new doctor in 2018 as they had gotten a horrific case of shingles on their face and neck and had no idea as their body by this time was so plagued by sores everywhere, and they were so used to being in pain from the inside out and feeling like they were on fire.Doctor looked at patient, told them they had shingles and prescribed medication.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be, "incorrect base mesh knit design - centerline is not properly located".The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: "precautions the usual precautions associated with urological procedures should be followed: - based on physician experience and training, a thorough assessment of each patient should be made to determine their suitability for the implant procedure.Additional consideration should be given to use of the implant in patients with a compromised immune system, any condition that would compromise healing, or any patient with a history of prior abdominal or pelvic surgeries.Consideration should also be given to the ability of the patient to tolerate the surgical procedure.- accepted surgical practice and precautions must be followed for the management of contaminated or infected wound sites, when the align® to urethral support system is used.- postoperative bleeding may occur in some patients and must be controlled prior to patient release.- the implant procedure requires diligent attention to anatomical structures and care to avoid puncture of large vessels, nerves, bladder, bowel, urethra and any viscera, during introducer passage.- due to anatomical distortion that can be caused by pelvic organ prolapse, if the patient requires cystocele repair, it should be performed prior to the implantation of the sub-urethral sling.- proper placement of the sling implant at the mid-urethra requires that it lie flat with minimal or no tension under the urethra.- the align® to urethral support system is intended as a single-use device.Do not re-sterilize any portion of the align® to urethral support system.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.- patients should be advised that pregnancy following a sling implant procedure may negatively affect the success of the previous implant procedure and incontinence may recur.- the safety and effectiveness of the align® to urethral support system implant procedure has not been established for the treatment of stress urinary incontinence in males and children under the age of 18.- cystoscopy can be considered at the physician¿s discretion.- check the integrity of the packaging before use.Do not use the align® to urethral support system if the packaging is opened or damaged.- as for any implantable material, it is recommended to open the package at the time of implantation.- post-operatively the patient should be advised to refrain from heavy lifting, exercise (e.G.Cycling, jogging) and/or intercourse until the physician determines it is suitable for the patient to return to normal activities.Adverse events complications associated with the proper implantation of the align® to urethral support system may include, but are not limited to: - postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.- urinary retention, bladder outlet obstruction and other voiding dysfunctions.These conditions may be associated with over-correction/too much tension placed on the implant.- perforations or lacerations of vessels, nerves, bladder, bowel, urethra, or any viscera, which may occur during the implantation procedure.- irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.- extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.- inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of incontinence." h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: ALIGN® TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM - HALO
• Type of Device: URETHRAL SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17631893
• MDR Text Key: 322061151
• Report Number: 1018233-2023-06383
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: BRD500HL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention