MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068318170

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Erosion (1750); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Obstruction/Occlusion (2422); Prolapse (2475); Dyspareunia (4505); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2021, was chosen as a best estimate based on the date of the mesh removal surgery.This event was reported by the patient's legal representation.The surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an uphold lite device was implanted into the patient during a procedure performed on (b)(6) 2011 as reported by the patient's attorney, the patient has experienced an unspecified injury and underwent a mesh removal surgery on (b)(6) 2021.

Manufacturer Narrative

Block h2: correction block b3 date of event has been corrected from february 2, 2011 to october 31, 2017.Block b3 date of event: the exact event onset date is unknown.The provided event date of october 31, 2017 was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The surgeon is: dr.(b)(6), united states.Block h6: patient code e2401 captures the reportable event of unspecified injury.Impact code f1903 captures the reportable event of mesh removal.

Event Description

It was reported to boston scientific corporation that an uphold lite device was implanted into the patient during a procedure performed on (b)(6) 2017.As reported by the patient's attorney, the patient has experienced an unspecified injury and underwent a mesh removal surgery on (b)(6) 2021.

Manufacturer Narrative

Blocks a1, a2, a4, b3, b5, b7, d6b, e1 below and h6: patient codes and impact codes have been updated based on the information received on october 13, 17 and 18, 2022.Block b3 date of event: date of event was approximated to (b)(6) 2017 based on the date exposure of mesh in and prosthetic material in vagina was noted.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) health.(b)(6) united states.Mesh removal surgeons are: dr.(b)(6).Dr.(b)(6).Dr.(b)(6).(same healthcare facility).Block h6: patient codes e2006, e2101, e2328, e1309, e2330, e1405, e1310, e2333 capture the reportable events of mesh exposure in vagina, adhesions, vaginal bulge, urinary retention, pain, dyspareunia, utis and recurrent prolapse.Impact codes f1905, f1901 and f2301 capture the reportable events of portions of mesh removed, lysis of adhesions surgery, intravesical botox injection 100 units, robotic - assisted laparoscopic sacral colpopexy and new mesh implanted.

Event Description

It was reported to boston scientific corporation that an uphold lite device was implanted into the patient during an uphold lite mesh augmented sacrospinous ligament fixation + anterior repair + cystoscopy procedure performed on (b)(6) 2017 for the treatment of vaginal vault and anterior wall prolapse.Since the implant in (b)(6) 2017, she was still able to do physical activities like walking, strength training, house cleaning except to a lesser degree.Patient claimed to have suffered, adhesions, uphold detached and wrapped around bowel - this was discovered during removal surgery in (b)(6) 2021, dyspareunia, hypertension, recurrent vaginal pain, throbbing and cramping pain due to vaginal bulge, urinary incontinence, vaginal vault prolapse, mesh migration and contraction, pain and suffering, and underwent revision/removal surgery.During an office visit on (b)(6) 2019, it was reported that exposure of the implanted vaginal mesh and prosthetic material in vagina was noted on (b)(6) 2017.In this encounter, the patient came for a one year postop follow up with a visit diagnosis of history of gynecologic surgery and rectocele.She did not need the device/mesh removed as she was doing well at that time with no apparent complications.The patient was advised to continue ongoing medical care and return in one year for a follow up and examination.She had medication list which included alprazolam, cetirizine, estradiol, fluticasone propionate, lisinopril, oxybutynin, premarin, and synthroid.On (b)(6) 2020, telephone encounter with the patient concerning overactive bladder, urge incontinence and prolapse, unspecified type.Discussed option of increasing oxybutynin to 15mg daily for overactive bladder, previously 10mg and it really helped.Patient did not want to do so but would like to discuss about it in person to consider.For follow up regarding pelvic organ prolapse, the patient was referred to a physician familiar with uphold device and would return for prolapse evaluation when able to schedule regular visits in person.For the meantime, the patient was advised to use coconut oil and vaginal estrogen as needed if discomfort becomes an issue to help moisture and prevent irritation.In this encounter, the patient stated that she noticed bulge in vagina that had worsened but was not uncomfortable or in pain and not seen as an urgent issue for her.Eventually, she would like to be checked once in - person visits were possible.She denied splinting to void or defecate but was taking miralax to avoid constipation and did not have to strain.On (b)(6) 2021, the patient presented for a consult.She reported that her primary concern was recurrent vaginal bulge about the size of an egg and vaginal discharge.She voided eight times per day and admitted to leakage with cough and sneeze and had leakage with urge.This had been going on for 12 years.She had nocturia, getting up 2 - 3 times per night to void.She had utis.She denied urinary retention but felt not always emptying her bladder well.She was assessed as having stage ii vvp with enterocele and good support in the anterior compartment, mixed urinary incontinence, and dyspareunia.Surgical and non - surgical treatment options were discussed.On (b)(6) 2021, the patient had to undergo repeat robotic - assisted laparoscopic sacral colpopexy, lysis of intra - abdominal adhesions, removal of intra - abdominal mesh from prior failed sacrocolpopexy, intravesical botox injection 100 units plus cystoscopy due to stage ll recurrent vvp with enterocele, dyspareunia and severe oab syndrome.The patient stated that the mesh was removed as it failed to treat her vaginal prolapse.The prolapse recurred and was protruding from her body.During the same procedure, boston scientific upsylon y - mesh was also implanted into the patient.There was no recommendation for it to be removed in whole or in part.The device remained implanted, and no complications reported.Findings: stage ii apical and posterial vaginal vault prolapse, significant adhesions between the omentum and anterior abdominal wall with adhesions continuing between the large bowel and pelvic sidewalls bilaterally, thick adhesion at the middle of the posterior vaginal apex that contained significant burden of mesh that was avulsed from the vaginal wall anteriorly and posteriorly.Uphold mesh was found in the vesicovaginal space with bilateral arms extending to the sacrospinous ligaments but visible intra - abdominally with no erosion.Patient had a large gap defect at the vaginal apex between the anterior mesh and the avulsed prior sacrocolpopexy mesh.Cystoscopy showed low - capacity bladder with multiple diffuse cellules and significant trabeculation at capacity with normal bilateral ureteral efflux.Procedure: the omentum was dissected off the anterior abdominal wall and attention was directed to the right pelvic sidewall.The adhesiolysis was continued until the large bowel was mobilized off the right pelvic sidewall.Encountered a blue mesh arm that was traversing the left cul - de - sac and continued down to the area of the sacrospinous ligament.This appeared to be intact.The mesh arm on the right side did not appear to be intact.A large, thickened wad of tissue was seen attached to the vaginal apex.Further dissection and mobilization revealed this to be a large piece of avulsed mesh from a prior sacral colpopexy - it had completely separated from the vagina.It was mobilized in its entirety.The mesh on the medial surface of the retroperitoneum was dissected as proximal as possible to the sacrum to remove it in its entirety.A mesh segment that was 4 cm wide and about 8 cm long was removed.There was an area of intraperitoneal mesh seen on the right aspect of the bladder from the patient's previous uphold procedure.This was dissected as well and removed and sent with the previous mesh for pathology.A y - mesh was then inserted into the abdomen after trimming to appropriate size.Lastly, all 100 units of botox had been injected, hemostasis was excellent.The patient tolerated the procedure well.She was awakened from anesthesia and transferred to the recovery room in good condition.On (b)(6) 2021, patient called and stated everything was working well with her bladder; however, she was having vaginal pain.Discussed with the patient of the residual swelling occurring and advised the patient to use ice in the vaginal area, rotate between tylenol and ibuprofen.

Manufacturer Narrative

Block h2: additional information: block b5 has been updated based on the additional information on november 15, 2022.Correction: blocks d6b and e1 (initial reporter address) has been corrected.Block b3 date of event: date of event was approximated to december 12, 2017 based on the date exposure of mesh in and prosthetic material in vagina was noted.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) health.Mesh removal surgeons are: dr.(b)(6).Dr.(b)(6).Dr.(b)(6).(same healthcare facility).Block h6: the following imdrf patient codes capture the reportable events of: e2328 - obstruction/occlusion.E2101 - adhesions.E1309 - urinary retention.E2330 - pain.E2006 - erosion.E1310 - urinary tract infection.E1405 - dyspareunia.E1401 - abnormal vaginal discharge.The following imdrf impact codes capture the reportable events of: f1905 - portions of mesh removed.F1901 - lysis of adhesions surgery.F2301 - intravesical botox injections 100 units, robotic - assisted laparoscopic sacral.Colpopexy and new mesh implanted.

Event Description

It was reported to boston scientific corporation that an uphold lite device was implanted into the patient during an uphold lite mesh augmented sacrospinous ligament fixation + anterior repair + cystoscopy procedure performed on (b)(6) 2017 for the treatment of vaginal vault and anterior wall prolapse.Since the implant in (b)(6) 2017, she was still able to do physical activities like walking, strength training, house cleaning except to a lesser degree.Patient claimed to have suffered, adhesions, uphold detached and wrapped around bowel - this was discovered during removal surgery in (b)(6) 2021, dyspareunia, hypertension, recurrent vaginal pain, throbbing and cramping pain due to vaginal bulge, urinary incontinence, vaginal vault prolapse, mesh migration and contraction, pain and suffering, and underwent revision/removal surgery.During an office visit on (b)(6) 2019, it was reported that exposure of the implanted vaginal mesh and prosthetic material in vagina was noted on (b)(6) 2017.In this encounter, the patient came for a one year postop follow up with a visit diagnosis of history of gynecologic surgery and rectocele.She did not need the device/mesh removed as she was doing well at that time with no apparent complications.The patient was advised to continue ongoing medical care and return in one year for a follow up and examination.She had medication list which included alprazolam, cetirizine, estradiol, fluticasone propionate, lisinopril, oxybutynin, premarin, and synthroid.On (b)(6) 2020, telephone encounter with the patient concerning overactive bladder, urge incontinence and prolapse, unspecified type.Discussed option of increasing oxybutynin to 15mg daily for overactive bladder, previously 10mg and it really helped.Patient did not want to do so but would like to discuss about it in person to consider.For follow up regarding pelvic organ prolapse, the patient was referred to a physician familiar with uphold device and would return for prolapse evaluation when able to schedule regular visits in person.For the meantime, the patient was advised to use coconut oil and vaginal estrogen as needed if discomfort becomes an issue to help moisture and prevent irritation.In this encounter, the patient stated that she noticed bulge in vagina that had worsened but was not uncomfortable or in pain and not seen as an urgent issue for her.Eventually, she would like to be checked once in - person visits were possible.She denied splinting to void or defecate but was taking miralax to avoid constipation and did not have to strain.On (b)(6) 2021, the patient presented for a consult.She reported that her primary concern was recurrent vaginal bulge about the size of an egg and vaginal discharge.She voided eight times per day and admitted to leakage with cough and sneeze and had leakage with urge.This had been going on for 12 years.She had nocturia, getting up 2 - 3 times per night to void.She had utis.She denied urinary retention but felt not always emptying her bladder well.She was assessed as having stage ii vvp with enterocele and good support in the anterior compartment, mixed urinary incontinence, and dyspareunia.Surgical and non - surgical treatment options were discussed.On (b)(6) 2021, the patient had to undergo repeat robotic - assisted laparoscopic sacral colpopexy, lysis of intra - abdominal adhesions, removal of intra - abdominal mesh from prior failed sacrocolpopexy, intravesical botox injection 100 units plus cystoscopy due to stage ll recurrent vvp with enterocele, dyspareunia and severe oab syndrome.The patient stated that the mesh was removed as it failed to treat her vaginal prolapse.The prolapse recurred and was protruding from her body.During the same procedure, boston scientific upsylon y - mesh was also implanted into the patient.There was no recommendation for it to be removed in whole or in part.The device remained implanted, and no complications reported.Findings: stage ii apical and posterial vaginal vault prolapse, significant adhesions between the omentum and anterior abdominal wall with adhesions continuing between the large bowel and pelvic sidewalls bilaterally, thick adhesion at the middle of the posterior vaginal apex that contained significant burden of mesh that was avulsed from the vaginal wall anteriorly and posteriorly.Uphold mesh was found in the vesicovaginal space with bilateral arms extending to the sacrospinous ligaments but visible intra - abdominally with no erosion.Patient had a large gap defect at the vaginal apex between the anterior mesh and the avulsed prior sacrocolpopexy mesh.Cystoscopy showed low - capacity bladder with multiple diffuse cellules and significant trabeculation at capacity with normal bilateral ureteral efflux.Procedure: the omentum was dissected off the anterior abdominal wall and attention was directed to the right pelvic sidewall.The adhesiolysis was continued until the large bowel was mobilized off the right pelvic sidewall.Encountered a blue mesh arm that was traversing the left cul - de - sac and continued down to the area of the sacrospinous ligament.This appeared to be intact.The mesh arm on the right side did not appear to be intact.A large, thickened wad of tissue was seen attached to the vaginal apex.Further dissection and mobilization revealed this to be a large piece of avulsed mesh from a prior sacral colpopexy - it had completely separated from the vagina.It was mobilized in its entirety.The mesh on the medial surface of the retroperitoneum was dissected as proximal as possible to the sacrum to remove it in its entirety.A mesh segment that was 4 cm wide and about 8 cm long was removed.There was an area of intraperitoneal mesh seen on the right aspect of the bladder from the patient's previous uphold procedure.This was dissected as well and removed and sent with the previous mesh for pathology.A y - mesh was then inserted into the abdomen after trimming to appropriate size.Lastly, all 100 units of botox had been injected, hemostasis was excellent.The patient tolerated the procedure well.She was awakened from anesthesia and transferred to the recovery room in good condition.On (b)(6) 2021, patient called and stated everything was working well with her bladder; however, she was having vaginal pain.Discussed with the patient of the residual swelling occurring and advised the patient to use ice in the vaginal area, rotate between tylenol and ibuprofen.Boston scientific received an additional information on november 15, 2022 as follows: the patient had an abdominal sacrocolpopexy on (b)(6) 2000, to address central vaginal vault prolapse.There was a central vault prolapse near the introitus at the time of surgery.There were only a few filmy adhesions of the bowel to the previous vaginal closure and bladder dome at the time of the laparotomy.Furthermore, a prolene mesh around 2 cm wide was added throughout the process by inserting them through the mesh and then tying them down.The length of the mesh was adjusted before attaching it to the top of the vagina so that there would be no tension, and the mesh was placed in the posterior cul-de-sac, suspending the vaginal vault.It should be noted that 0-vicryl was used to place a purse-string cul-de-sac closure suture, and a second one was closed over the first to close the cul-de-sac.The mesh hammock then lies on upon this culdoplasty.The bowel was allowed to lay over the mesh with good vault suspension.Hemostasis was noted to be adequate at all points.After inspecting the vagina and finding good vault suspension, the patient was awakened from her general anesthesia, and taken to the recovery room in good condition, having tolerated the procedure well.

• Brand Name: UPHOLD LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14764624
• MDR Text Key: 294541991
• Report Number: 3005099803-2022-03393
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000054922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 55 KG