MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068502110

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Anemia (1706); Purulent Discharge (1812); Fatigue (1849); Fever (1858); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Chills (2191); Hernia (2240); Anxiety (2328); Discomfort (2330); Malaise (2359); Obstruction/Occlusion (2422); Prolapse (2475); Dysuria (2684); Constipation (3274); Suicidal Ideation (4429); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 07/06/2020

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2020.As reported by the patient's attorney, the patient has experienced an unspecified injury.

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6) 2020, was chosen as a best estimate based on the date of the mesh was implanted.This event was reported by the patient's legal representation.The surgeons are dr.(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.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of july 6, 2020, 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 implanting surgeons are: (b)(6).Explanting surgeon: (b)(6).Block h6: patient code e1405, e0126, e2312, e1301, e2330, e0123 and e0205 capture the reportable events of dyspareunia, neuropathy, fatigue, dysuria, pain, nerve damage and suicidal ideation.Impact code f1903 and f2303 capture the reportable events of medication required, partial removal of mesh.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a device 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 advantage fit system device was implanted into the patient during a procedure performed on (b)(6), 2020.As reported by the patient's attorney, the patient has experienced an unspecified injury.Boston scientific received an additional information on (b)(6), 2022, as follows: on (b)(6), 2020, the patient was implanted with non-bsc sacrocolpopexy mesh during a robotic assisted laprascopic abdominal sacrocolplexy, rectoplexy, and supercervical hysterectomy with vaginal repair procedure.Prior to the procedure, the patient had been diagnosed with uterovaginal prolapse, rectocele, cystocele and introsusception of the colon.After mesh implantation, she began to experience urinary leakage.On (b)(6), 2020, the patient was admitted to the hospital due to extreme pain.A lump was found at the incision site which was subsequently drained.On (b)(6), 2020, the patient was found to be septic with a kidney infection.While hospitalized, she developed constipation and severe pain with bowel movements and had surgery to clean out her impacted bowels.On (b)(6) 2020, an advantage fit system device was implanted into the patient during a robotic assisted rectopexy, endo adult esophagogastroduodenoscopy/flexible sigmoidoscopy, transvaginal urethral sling with cystoscopy and graft, mesh or fascia procedure for the treatment of internal complete rectal prolapse with intussusception of rectosigmoid and stress urinary incontinence.Reportedly, the patient tolerated the procedure well and was taken to the recovery room in a stable condition.Immediately after the implantation, the patient woke up with a shooting pain in her vagina and the rectum, as if someone was poking it with the knife.On the right, this was a little more severe.This pain was shooting down her back.She also experienced significant constipation.She saw a physical therapist for the pelvic floor, who noted that her pelvic floor is quite tight.On (b)(6) 2021, the patient woke up unable to feel her legs or walk.Two days prior, the patient underwent a computerized tomography (ct) scan, which revealed a lump in the anastomosis region.The physician reported no evidence of leak from the colorectal anastomosis.Reportedly, the lump pressing on her spinal cord was found to be an infection in her spinal cord.After an extensive workup, she was diagnosed with osteomyelitis at the level of l5s1.The patient received an intravenous vancomycin for a spinal cord infection during her two weeks in the hospital.Methicillin-resistant staphylococcus aureus was grown in the cultures.After taking antibiotics, she was eventually able to walk once more.The patient was informed that mesh needed to be removed since it was infected.On (b)(6), 2021, the patient underwent a laparoscopic removal of the sacrocolpopexy mesh, laparoscopic pelvic exploration, and proctoscopy, but there was no evidence that any of the advantage fit mesh was removed.The surgeon began the surgery and carried out an examination while sedated (laparoscopy).He then went on to remove the sacrocolpopexy mesh that had been in situ from the cervix to the sacrum.Additionally, he checked the bladder and did a cystoscopy.To ensure there was no damage to the colon, the surgeon scrubbed in and assisted with the pelvic mobilization laparoscopically.To make sure there was no leak from the anastomosis on the air-leak test, the surgeon performed proctoscopy while the anastomosis was submerged in saline in addition to laparoscopic inspection.On (b)(6), 2022, the patient had a consult with a pain clinic due to persistent pain despite having her sacrocolpopexy mesh removed.The patient claims that her current pain is more severe than the discomfort from the prolapse.During conversation with the physician, the patient reported that she experiences pain during sex to the extent that she refrains from sexual activity and worries about her marriage.She is hesitant and constipated.Due to her sensitivities, she is unable to wear tight pants, and the pain is so severe that she has occasionally thought she does not want to live.She also experienced significant hesitancy and had difficulty urinating.The report states that there is bilateral lower back tenderness, significant lower abdomen tenderness, a positive carnett's sign, intense pelvic floor muscle tenderness, and extremely painful mid-urethral tenderness at the location where the sling was applied.In addition, the following was the doctor's evaluation at the patient's consultation: causalgia of bilateral lower limbs.Pudendal neuralgia; spastic pelvic floor syndrome.Subsequently, they have opted to take out the superior fit mesh after much deliberation.A burch technique is not advised by the surgeon due to the possibility of gore-tex sutures becoming contaminated.The patient would also undergo a bilateral pudendal nerve block and a pelvic floor muscle botox injection.Reportedly, the patient will be a candidate for an injection of amniofix into both pudendal nerves if there is no improvement, and she may also need a continuous on-q pain pump to lower her central nervous system activity.The patient might also be a candidate for a bilateral trans-gluteal pudendal neurolysis if those treatments don't work.The surgeon and patient and had a thorough discussion about everything.The patient understands and wishes to proceed with mesh removal.On (b)(6) 2022, the patient underwent the following procedure for the treatment of implanted vaginal mesh complication, spastic pelvic floor syndrome and pudendal neuralgia: *vaginal removal of vaginal sling *robotic assisted laparoscopic removal of sling arms *robotic assisted laparoscopic removal of sacrocolpopexy mesh *bilateral pudendal nerve block *botox injection to pelvic floor muscles *cystoscopy using 20 ml of 0.5% bupivacaine and adrenaline, the initial bilateral pudendal nerve block was performed during the procedure.10 ml were injected into each ischial spine using a pudendal nerve block needle.20 ml of regular sterile saline were used to dilute 200 units of botulinum toxin a.It was administered bilaterally into the pelvic floor muscles 20 times with a volume of 1 ml each using a pudendal nerve block needle.It was injected into eight muscles.A weighted speculum was also inserted into the vagina, and the lonestar retractor was utilized to reveal the surgical site.Ten milliliters of 0.5% marcaine with epinephrine were injected into the anterior vaginal wall.After making a small vertical incision in the anterior vaginal wall, a white polypropylene sling was noticed.It was detached from the surrounding vaginal tissues and underlying urethra.This sling was divided down the middle, and two kocher clamps were attached to each end when it was discovered to be free all the way behind the pubic ramus.The robotic component of the process then caught their attention.As usual, robotic ports were placed.The results of the evaluation of the abdomen and pelvis are mentioned above.The sigmoid colon was strongly adhered to the presacral region.The cervix was present and had two areas of white mesh that were clearly visible--one in the front and one in the back.The bladder and rectum were detached from the cervix using sharp and blunt dissection, and the two pieces of the previous sacral cervicopexy mesh were taken out and transferred.There was some bleeding there, but arista and floseal were able to stop it.Their attention then turned to the exploration of the retropubic area.The sigmoid colon reportedly had strong adhesions to the presacral region.The sigmoid colon was moved away from the presacral region using meticulous sharp and blunt dissection.The anterior longitudinal ligament was observed, and the aortic bifurcation could be seen.No mesh or sutures were visible in this region.Their attention then turned to the removal of retropubic mesh.Moreover, a 400ml of regular sterile saline was placed in the bladder.The retropubic space was then accessed entered through an incision in the peritoneum anterior to the bladder.Bipolar cautery was used to control bleeding from tiny vessels.It was possible to see the left side of the retropubic mesh against the pubic bone's backside.It was discovered to be in its proper place.The mesh was dissected toward the anterior abdominal wall with meticulous and time-consuming dissection, and the entire piece, including the portion in the rectus abdominis muscle, was removed.It was then dissected towards the pelvic floor until the entry of the mesh through the anterior attachment of the levator muscle.The kocher clamp attached to the vaginal portion of the mesh on the left side was then pushed into the pelvis and the entire piece of mesh was dissected out.Excellent hemostasis was noted.The mesh on the right side was then identified.It was also found to be in the correct position.The entire mesh on the right side was removed in an identical manner to the removal of the left mesh.The entire area was irrigated, and arista was used to obtain excellent hemostasis.Furthermore, the on-q pain pump catheter was then placed in the retropubic space and connected to the pump filled with 0.2% ropivacaine.It was set to run at 6 ml/h.The fascia of the umbilical port was closed with 0 vicryl and the skin of all ports was closed with 4-0 monocryl.Small openings in the pelvic floor muscles were closed with 3-0 vicryl bilaterally and the vaginal epithelium was closed with a running suture of 3-0 vicryl.Cystoscopy was performed and no injuries to the bladder or urethra were noted.This concluded the procedure.The patient tolerated the procedure well.She was taken to the recovery room in stable condition.

Manufacturer Narrative

Block h2: correction block b5 narrative updated block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2020, 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 implanting surgeons are: (b)(6).Explanting surgeon: (b)(6).Block h6: patient code e1405, e0126, e2312, e1301, e2330, e0123 and e0205 capture the reportable events of dyspareunia, neuropathy, fatigue, dysuria, pain, nerve damage and suicidal ideation.Impact code f1903 and f2303 capture the reportable events of medication required, partial removal of mesh.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a device 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 advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2020.As reported by the patient's attorney, the patient has experienced an unspecified injury.Boston scientific received an additional information on (b)(6) 2022, as follows: it was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a robotic assisted rectopexy, endo adult esophagogastroduodenoscopy/flexible sigmoidoscopy, transvaginal urethral sling with cystoscopy and graft, mesh or fascia procedure performed on (b)(6), 2020, for the treatment of internal complete rectal prolapse with intussusception of rectosigmoid and stress urinary incontinence.Reportedly, the patient tolerated the procedure well and was taken to the recovery room in a stable condition.Immediately after the implantation, the patient woke up with a shooting pain in her vagina and the rectum, as if someone was poking it with the knife.On the right, this was a little more severe.She also experienced severe constipation.This pain was shooting down her back.The patient noticed that she could not wear any clothing that touched her skin in the perineal region.She also saw a physical therapist for the pelvic floor, who noted that her pelvic floor is quite tight.After that, the patient underwent a computerized tomography (ct) scan, which revealed a lump in the anastomosis region.She was unable to walk when she awoke the next morning, two days later.Reportedly, the lump pressing on her spinal cord was found to be an infection in her spinal cord.The patient received an intravenous vancomycin for a spinal cord infection during her two weeks in the hospital.Methicillin-resistant staphylococcus aureus was grown in the cultures.After taking antibiotics, she was eventually able to walk once more.The patient was informed that all of her meshes needed to be removed since they were infected.On (b)(6) 2021, the patient underwent a laparoscopic removal of the sacrocolpopexy mesh, laparoscopic pelvic exploration, and proctoscopy, but there was no evidence that any of the advantage fit mesh was removed.The surgeon began the surgery and carried out an examination while sedated (laparoscopy).He then went on to remove the sacrocolpopexy mesh that had been in situ from the cervix to the sacrum.Additionally, he checked the bladder and did a cystoscopy.To ensure there was no damage to the colon, the surgeon scrubbed in and assisted with the pelvic mobilization laparoscopically.To make sure there was no leak from the anastomosis on the air-leak test, the surgeon performed proctoscopy while the anastomosis was submerged in saline in addition to laparoscopic inspection.The patient's pain persisted despite having her mesh removed.Because it was so severe, she was unable to engage in any sexual activity.She also experienced significant hesitancy and had difficulty urinating.Her doctor claimed that all the mesh had been taken out, but it looks like she still has a retropubic sling.The patient claims that the discomfort from the prolapse was nowhere near the severe pain she has been feeling lately.The patient complained of pelvic pain on (b)(6), 2022.The report states that there is bilateral lower back tenderness, significant lower abdomen tenderness, a positive carnett's sign, intense pelvic floor muscle tenderness, and extremely painful mid-urethral tenderness at the location where the sling was applied.In addition, the following was the doctor's evaluation at the patient's consultation: causalgia of bilateral lower limbs pudendal neuralgia spastic pelvic floor syndrome the patient and the surgeon had a long discussion.According to reports, the patient was pain-free before the advantage fit suburethral retropubic sling was applied.The patient woke up in the recovery room with sever neuropathic pain in her perineal area just after the sling was put on.Her anastomotic leak following bowel surgery, which most likely infected her sacralcervicopexy mesh, came after she was told it would get better with time.The patient was given a lengthy course of vancomycin treatment before being eventually transported back to the operating room, when the sacralcervicopexy mesh was reportedly removed.Unfortunately, she was still in pain after doing this.Reportedly, when sitting, the patient's pain is severe.She experiences pain during sex to the extent that she refrains from sexual activity and worries about her marriage.She is hesitant and constipated.Due to her sensitivities, she is unable to wear tight pants, and the pain is so severe that she has occasionally thought she does not want to live.Subsequently, they have opted to take out the superior fit mesh after much deliberation.A burch technique is not advised by the surgeon due to the possibility of gore-tex sutures becoming contaminated.The patient would also undergo a bilateral pudendal nerve block and a pelvic floor muscle botox injection.Reportedly, the patient will be a candidate for an injection of amniofix into both pudendal nerves if there is no improvement, and she may also need a continuous on-q pain pump to lower her central nervous system activity.The patient might also be a candidate for a bilateral trans-gluteal pudendal neurolysis if those treatments don't work.The surgeon and patient and had a thorough discussion about everything.The patient understands and wishes to proceed with mesh removal.On (b)(6), 2022, the patient underwent the following procedure for the treatment of implanted vaginal mesh complication, spastic pelvic floor syndrome and pudendal neuralgia.Vaginal removal of vaginal sling.Robotic assisted laparoscopic removal of sling arms.Robotic assisted laparoscopic removal of sacrocolpopexy mesh.Bilateral pudendal nerve block\ botox injection to pelvic floor muscles\ cystoscopy.Using 20 ml of 0.5% bupivacaine and adrenaline, the initial bilateral pudendal nerve block was performed during the procedure.10 ml were injected into each ischial spine using a pudendal nerve block needle.20 ml of regular sterile saline were used to dilute 200 units of botulinum toxin a.It was administered bilaterally into the pelvic floor muscles 20 times with a volume of 1 ml each using a pudendal nerve block needle.It was injected into eight muscles.A weighted speculum was also inserted into the vagina, and the lonestar retractor was utilized to reveal the surgical site.Ten milliliters of 0.5% marcaine with epinephrine were injected into the anterior vaginal wall.After making a small vertical incision in the anterior vaginal wall, a white polypropylene sling was noticed.It was detached from the surrounding vaginal tissues and underlying urethra.This sling was divided down the middle, and two kocher clamps were attached to each end when it was discovered to be free all the way behind the pubic ramus.The robotic component of the process then caught their attention.As usual, robotic ports were placed.The results of the evaluation of the abdomen and pelvis are mentioned above.The sigmoid colon was strongly adhered to the presacral region.The cervix was present and had two areas of white mesh that were clearly visible--one in the front and one in the back.The bladder and rectum were detached from the cervix using sharp and blunt dissection, and the two pieces of the previous sacral cervicopexy mesh were taken out and transferred.There was some bleeding there, but arista and floseal were able to stop it.Their attention then turned to the exploration of the retropubic area.The sigmoid colon reportedly had strong adhesions to the presacral region.The sigmoid colon was moved away from the presacral region using meticulous sharp and blunt dissection.The anterior longitudinal ligament was observed, and the aortic bifurcation could be seen.No mesh or sutures were visible in this region.Their attention then turned to the removal of retropubic mesh.Moreover, a 400ml of regular sterile saline was placed in the bladder.The retropubic space was then accessed entered through an incision in the peritoneum anterior to the bladder.Bipolar cautery was used to control bleeding from tiny vessels.It was possible to see the left side of the retropubic mesh against the pubic bone's backside.It was discovered to be in its proper place.The mesh was dissected toward the anterior abdominal wall with meticulous and time-consuming dissection, and the entire piece, including the portion in the rectus abdominis muscle, was removed.It was then dissected towards the pelvic floor until the entry of the mesh through the anterior attachment of the levator muscle.The kocher clamp attached to the vaginal portion of the mesh on the left side was then pushed into the pelvis and the entire piece of mesh was dissected out.Excellent hemostasis was noted.The mesh on the right side was then identified.It was also found to be in the correct position.The entire mesh on the right side was removed in an identical manner to the removal of the left mesh.The entire area was irrigated, and arista was used to obtain excellent hemostasis.Furthermore, the on-q pain pump catheter was then placed in the retropubic space and connected to the pump filled with 0.2% ropivacaine.It was set to run at 6 ml/h.The fascia of the umbilical port was closed with 0 vicryl and the skin of all ports was closed with 4-0 monocryl.Small openings in the pelvic floor muscles were closed with 3-0 vicryl bilaterally and the vaginal epithelium was closed with a running suture of 3-0 vicryl.Cystoscopy was performed and no injuries to the bladder or urethra were noted.This concluded the procedure.The patient tolerated the procedure well.She was taken to the recovery room in stable condition.Boston scientific received an additional information on (b)(6), 2022, as follows: prior to her procedure on (b)(6) 2021, the patient stated that she had developed increasing fatigue and back pain of unknown etiology over the previous several weeks.An extensive workup revealed that the patient had osteomyelitis at the l5s1 level (lumbosacral joint).

Manufacturer Narrative

Blocks b5 and h6 has been updated based on the additional information received on september 27, 2022.Correction: blocks e2 health professional and h6 evaluation conclusion codes has been corrected.Block b3 date of event: the exact event onset date is unknown.The provided event date of july 6, 2020, 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 implanting surgeons are: dr.(b)(6).Block h6: patient code e0205, e020201, e1715, e1301, e1906, e0123, e2326, e2326, e020204, e2401, e2328, e2330, e1002, e1405 capture the reportable events of suicidal ideation, anxiety, scar tissue, dysuria, infection, nerve damage, inflammation, neuropathy, malaise, unspecified injury, bowel obstruction, pain, abdominal pain, dyspareunia.Impact code f1903 and f2303 capture the reportable events of medication required, partial removal of mesh.

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a robotic assisted rectopexy, endo adult esophagogastroduodenoscopy/flexible sigmoidoscopy, transvaginal urethral sling with cystoscopy and graft, mesh or fascia procedure performed on (b)(6), 2020, for the treatment of internal complete rectal prolapse with intussusception of rectosigmoid and stress urinary incontinence.Reportedly, the patient tolerated the procedure well and was taken to the recovery room in a stable condition.Immediately after the implantation, the patient woke up with a shooting pain in her vagina and the rectum, as if someone was poking it with the knife.On the right, this was a little more severe.She also experienced severe constipation.This pain was shooting down her back.The patient noticed that she could not wear any clothing that touched her skin in the perineal region.She also saw a physical therapist for the pelvic floor, who noted that her pelvic floor is quite tight.After that, the patient underwent a computerized tomography (ct) scan, which revealed a lump in the anastomosis region.She was unable to walk when she awoke the next morning, two days later.Reportedly, the lump pressing on her spinal cord was found to be an infection in her spinal cord.The patient received an intravenous vancomycin for a spinal cord infection during her two weeks in the hospital.Methicillin-resistant staphylococcus aureus was grown in the cultures.After taking antibiotics, she was eventually able to walk once more.The patient was informed that all of her meshes needed to be removed since they were infected.On march 31, 2021, the patient underwent a computed tomography (ct scan).During the procedure, it was revealed that there is a soft tissue thickening versus phlegmon at the level of the rectosigmoid anastomosis extending towards the right adnexa and sacrum along the rectocolpopexy.This may represent infection versus inflammation, less likely postsurgical scarring.Colonoscopy is recommended to rule out underlying mass lesion within the rectum.There was no contrast leak or drainable fluid collections noted.On april 2, 2021, the patient claims that despite taking antibiotics, she is still experiencing severe pelvic pain, back pain, and rectal pressure.She expresses her inability to elevate her legs due to pelvic and back pain.During bowel movements, she manually disintegrates stools.Her stools are hard and pellet-like, according to her.She then experiences 1-2 loose bowel motions after passing pellet-like feces.She says that her feces are occasionally red, but she denies any obvious bleeding.She denies having any urinary changes.She also denies having incontinence.She is given baclofen, which aids with stool evacuation.Additionally, the patient had rectosigmoid thickening of unknown cause on the computed tomography scan.They began the patient on antibiotics even though she did not have an abscess or an anastomotic leak, and the antibiotics did not seem to help.The doctor has advised her to obtain an urgent endoscopy to rule out an anastomosis problem, although considering that she is a year out, this would be exceptional in terms of developing a leak or abscess.She does not have significant proximal colon dilation, which would suggest stenosis, but the physician wants to rule that out with an endoscopy.According to the physician, the patient has significant pelvic floor dyssynergia and is still having significant difficulties evacuating stool.The patient will begin using a suppository containing lidocaine, flexeril, and diazepam to determine if it aids in the evacuation.She had previously taken baclofen orally, and it seemed to have helped.Finally, the physician has requested the patient to contact her primary care physician since she also complains of significant back pain at the level of the pelvis as well as sometimes difficulty moving her leg.The doctor thinks it is important for her to seek the advice of experts in other fields to rule out any possible causes of her pelvic pain.She seems to be on agreement with the plan.Moreover, a review of the systems is as follows during her consultation: gastrointestinal: positive for abdominal pain.Negative for blood in stool, constipation, diarrhea, heartburn, melena, nausea and vomiting.Genitourinary: negative for dysuria, flank pain, frequency, hematuria and urgency.Musculoskeletal: positive for back pain.Negative for falls, joint pain, myalgias and neck pain.On april 4, 2021, the patient sought for a medical attention fir a potential sigmoid anastomosis leak and phlegmon.According to reports, the patient presented to occupational safety and health with bilateral lower extremity weakness caused by back pain and underwent magnetic resonance imaging (mri) to rule out l5-s1 discitis-osteomyelitis.Additionally, the computed tomography result revealed potential phlegmon at the rectosigmoid anastomosis, and she was started on flagyl.Furthermore, the general surgery department reviewed the results and found that no surgical treatments were necessary.According to infectious disease recommendations, the patient has been expanded to vancomycin and is awaiting a ct-guided bone marrow biopsy to help guide antibiotic therapy.The patient's gastrointestinal tract has been examined for the possibility of anastomotic phlegmon and infectious source sampling.Additionally, a computed tomography result date april 5, 2021, revealed an overall similar appearance of rectosigmoid inflammatory changes which extend towards the bilateral adnexa.These inflammatory changes are contiguous with presacral/prevertebral soft tissue thickening at the level of l5-s1.Prior to her procedure on (b)(6) 2021.The patient stated that she had developed increasing fatigue and back pain of unknown etiology over the previous several weeks.An extensive workup revealed that the patient had osteomyelitis at the l5s1 level (lumbosacral joint).On may 3, 2021, the patient underwent a laparoscopic removal of the sacrocolpopexy mesh, laparoscopic pelvic exploration, and proctoscopy, but there was no evidence that any of the advantage fit mesh was removed.The surgeon began the surgery and carried out an examination while sedated (laparoscopy).He then went on to remove the sacrocolpopexy mesh that had been in situ from the cervix to the sacrum.Additionally, he checked the bladder and did a cystoscopy.To ensure there was no damage to the colon, the surgeon scrubbed in and assisted with the pelvic mobilization laparoscopically.To make sure there was no leak from the anastomosis on the air-leak test, the surgeon performed proctoscopy while the anastomosis was submerged in saline in addition to laparoscopic inspection.The patient's pain persisted despite having her mesh removed.Because it was so severe, she was unable to engage in any sexual activity.She also experienced significant hesitancy and had difficulty urinating.Her doctor claimed that all the mesh had been taken out, but it looks like she still has a retropubic sling.The patient claims that the discomfort from the prolapse was nowhere near the severe pain she has been feeling lately.On may 19, 2021, the patient reported feeling well and experiencing only minor pain.She only needs gabapentin or naproxen when she has spent the entire day walking around the mall.The patient denies experiencing urinary issues, constipation, incontinence, or symptoms of recurrent prolapse.The patient also stated having a phone appointment with the doctor about her uncontrolled anxiety.She says, however, that her anxiety has lessened by 95% since she was able to see her children and refuses to take anxiety medication.According to reports, the patient was sent to the operating room on (b)(6) for mesh removal, and all mesh at the sacrum level was removed.The anastomosis was examined laparoscopically and found to be leak-free.Some mesh material, however, was retained and was embedded within the connective tissue.In addition, the patient states that she is doing significantly better after her discharge.She admits to having some pain, but it has greatly improved and is being managed with baclofen, celebrex, and gabapentin.The patient claims to be in pain, mild pain in the lower back, minimal pain in the upper back that feels like a muscle strain.Although the patient's wound looked to be healing nicely, she was still experiencing chills but no fevers or rigors.On june 2, 2021, the patient reports that she is doing well, although she notes that her back pain has gotten a little bit worse.She has been driving more and her car has bucket seats, which she thinks is responsible for her worsening pain.The pain is not nearly as bad as it was previously.Her upper back pain has resolved, although she sometimes experiences a pulling sensation when she wears a purse.She denies any weakness in her legs or any numbness or tingling.No bladder or bowel incontinence and no fevers or chills.Per discussion with urogyn, there is a residual mesh in between the bladder and vagina.All the mesh found near the spine was removed, though it is possible that some residual sutures and mesh remained that could not be found.The plan is to complete three months of therapy, including rifamycin, then will consider stopping versus a period of chronic suppression.The patient will eventually require lumbar interbody fusion.On october 21, 2021, the patient reports feeling very unwell.She is still experiencing from significant lower and midback pain.She is still experiencing diffuse abdominal discomfort and pain, as well as a pulling sensation in her abdomen.She recalls that her symptoms began to increase in july, before she stopped taking her oral antibiotics.In addition, she has experienced recurring abnormal stools that are fluffy or white and mucous-like, float and then sink, and at times are very stringy small caliber stools.She believes that something is obstructing her feces and that she must take an enema to make a bowel movement.This was also an issue before to her rectoplexy/sigmoidectomy in 2020, but it improved following surgery.She also claims that her acid reflux has worsened and that she has been vomiting every night.She is generally unwell, suffering from fatigue, malaise, and brain fog.There are no fevers, although there are occasional chills.On november 2, 2021, the patient experiences lower abdominal pain, mostly on the right side, and bloating that began around five to seven years ago.Her abdominal pain is dull and cramping, with the occasional sharp pain.She has abdominal pain a few times a week that lasts for varied amounts of time.She reports that bowel movements relieve her abdominal pain.She seems to have no recall of any events preceding the onset of abdominal pain and denies having undergone surgery, infection, or trauma.There were no particular food triggers found.She notices an increase in bloating after meals.A colonoscopy five to seven years ago revealed rectocele and vaginal prolapse.She had previously tried antacid medications without improvement.With regards to her bowel movements, she has one to three hard, ball-like stools in a day, though this can be variable in consistency.She also experiences the urge to have a bowel movement but then only sees mucous output.She reports straining and the sensation of incomplete evacuation.She takes miralax daily.She does not take fiber supplements due to abdominal cramping previously but tries to eat oatmeal daily.She uses a tap water or saline enema daily.She reports completing anorectal manometry testing in 2019 and biofeedback sessions in 2020 and most recently in march 2021 with mild improvement in constipation.Moreover, the physician suspects her symptoms are likely multifactorial related to irritable bowel syndrome (given improvement with bowel movements), chronic constipation, and visceral hypersensitivity.Lower suspicion for iso, appendicitis, chronic pancreatitis (normal pancreas on imaging), peptic ulcer disease (no ulcers on recent ego), or malignancy.Although cholelithiasis was seen on computed tomography, her history does not sound consistent with biliary colic.We recommend a colonoscopy for further evaluation to see if the active colitis has resolved, and she is also due for colon cancer screening.With regards to her acid reflux and regurgitation symptoms, she has a history of nissen fundoplication.They recommend a trial of maximal acid suppression for treatment of gastroesophageal reflux disease (gerd) with increasing proton pump inhibitor dosing to twice daily dosing.Given her symptoms of dysphagia to solids, they advise her to have esophageal biopsies and gastric biopsies repeated to rule out esophageal eosinophilic esophagitis (eoe).If esophageal biopsies are unremarkable and she experiences no improvement on proton pump inhibitor, they can consider further work up with manometry to evaluate for motility disorders and ph testing to determine severity of reflux and whether her symptoms acid reflux.On december 9, 2021, the patient presented to the clinic for evaluation of severe defecatory dysfunction symptoms.As a result, the patient seeks a second opinion.The patient also claims to have a mesh infection and thus to digitally remove her bowel movements.According to reports, the patient is frustrated by her symptoms.She was presented with the choice of undergoing back surgery for rod placement due to l5-s1 discitis osteomyelitis.She is also frustrated by bowel movements that need digitation and enemas, and she wonders if this should be addressed prior to any spine surgery.The patient complained of pelvic pain on march 9, 2022.The report states that there is bilateral lower back tenderness, significant lower abdomen tenderness, a positive carnett's sign, intense pelvic floor muscle tenderness, and extremely painful mid-urethral tenderness at the location where the sling was applied.In addition, the following was the doctor's evaluation at the patient's consultation: causalgia of bilateral lower limbs pudendal neuralgia spastic pelvic floor syndrome.The patient and the surgeon had a long discussion.According to reports, the patient was pain-free before the advantage fit suburethral retropubic sling was applied.The patient woke up in the recovery room with sever neuropathic pain in her perineal area just after the sling was put on.Her anastomotic leak following bowel surgery, which most likely infected her sacralcervicopexy mesh, came after she was told it would get better with time.The patient was given a lengthy course of vancomycin treatment before being eventually transported back to the operating room, when the sacralcervicopexy mesh was reportedly removed.Unfortunately, she was still in pain after doing this.Reportedly, when sitting, the patient's pain is severe.She experiences pain during sex to the extent that she refrains from sexual activity and worries about her marriage.She is hesitant and constipated.Due to her sensitivities, she is unable to wear tight pants, and the pain is so severe that she has occasionally thought she does not want to live.Subsequently, they have opted to take out the superior fit mesh after much deliberation.A burch technique is not advised by the surgeon due to the possibility of gore-tex sutures becoming contaminated.The patient would also undergo a bilateral pudendal nerve block and a pelvic floor muscle botox injection.Reportedly, the patient will be a candidate for an injection of amniofix into both pudendal nerves if there is no improvement, and she may also need a continuous on-q pain pump to lower her central nervous system activity.The patient might also be a candidate for a bilateral trans-gluteal pudendal neurolysis if those treatments don't work.The surgeon and patient and had a thorough discussion about everything.The patient understands and wishes to proceed with mesh removal.On (b)(6) 2022, the patient underwent the following procedure for the treatment of implanted vaginal mesh complication, spastic pelvic floor syndrome and pudendal neuralgia.Vaginal removal of vaginal sling robotic assisted laparoscopic removal of sling arms robotic assisted laparoscopic removal of sacrocolpopexy mesh bilateral pudendal nerve block botox injection to pelvic floor muscles cystoscopy.Using 20 ml of 0.5% bupivacaine and adrenaline, the initial bilateral pudendal nerve block was performed during the procedure.10 ml were injected into each ischial spine using a pudendal nerve block needle.20 ml of regular sterile saline were used to dilute 200 units of botulinum toxin a.It was administered bilaterally into the pelvic floor muscles 20 times with a volume of 1 ml each using a pudendal nerve block needle.It was injected into eight muscles.A weighted speculum was also inserted into the vagina, and the lonestar retractor was utilized to reveal the surgical site.Ten milliliters of 0.5% marcaine with epinephrine were injected into the anterior vaginal wall.After making a small vertical incision in the anterior vaginal wall, a white polypropylene sling was noticed.It was detached from the surrounding vaginal tissues and underlying urethra.This sling was divided down the middle, and two kocher clamps were attached to each end when it was discovered to be free all the way behind the pubic ramus.The robotic component of the process then caught their attention.As usual, robotic ports were placed.The results of the evaluation of the abdomen and pelvis are mentioned above.The sigmoid colon was strongly adhered to the presacral region.The cervix was present and had two areas of white mesh that were clearly visible--one in the front and one in the back.The bladder and rectum were detached from the cervix using sharp and blunt dissection, and the two pieces of the previous sacral cervicopexy mesh were taken out and transferred.There was some bleeding there, but arista and floseal were able to stop it.Their attention then turned to the exploration of the retropubic area.The sigmoid colon reportedly had strong adhesions to the presacral region.The sigmoid colon was moved away from the presacral region using meticulous sharp and blunt dissection.The anterior longitudinal ligament was observed, and the aortic bifurcation could be seen.No mesh or sutures were visible in this region.Their attention then turned to the removal of retropubic mesh.Moreover, a 400ml of regular sterile saline was placed in the bladder.The retropubic space was then accessed entered through an incision in the peritoneum anterior to the bladder.Bipolar cautery was used to control bleeding from tiny vessels.It was possible to see the left side of the retropubic mesh against the pubic bone's backside.It was discovered to be in its proper place.The mesh was dissected toward the anterior abdominal wall with meticulous and time-consuming dissection, and the entire piece, including the portion in the rectus abdominis muscle, was removed.It was then dissected towards the pelvic floor until the entry of the mesh through the anterior attachment of the levator muscle.The kocher clamp attached to the vaginal portion of the mesh on the left side was then pushed into the pelvis and the entire piece of mesh was dissected out.Excellent hemostasis was noted.The mesh on the right side was then identified.It was also found to be in the correct position.The entire mesh on the right side was removed in an identical manner to the removal of the left mesh.The entire area was irrigated, and arista was used to obtain excellent hemostasis.Furthermore, the on-q pain pump catheter was then placed in the retropubic space and connected to the pump filled with 0.2% ropivacaine.It was set to run at 6 ml/h.The fascia of the umbilical port was closed with 0 vicryl and the skin of all ports was closed with 4-0 monocryl.Small openings in the pelvic floor muscles were closed with 3-0 vicryl bilaterally and the vaginal epithelium was closed with a running suture of 3-0 vicryl.Cystoscopy was performed and no injuries to the bladder or urethra were noted.This concluded the procedure.The patient tolerated the procedure well.She was taken to the recovery room in stable condition.

Manufacturer Narrative

Block h2: additional information block b5 (narrative) has been updated has been updated based on the additional information received on november 4, 2022.Block e1: initial reporter contact information updated block h6 - patient codes e2333 has been added.Block b3 date of event: the exact event onset date is unknown.The provided event date of july 6, 2020, 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 implanting surgeons are: (b)(6).Block h6: patient code e0205, e020201, e1715, e1301, e1906, e0123, e2326, e2326, e020204, e2401, e2328, e2330, e1002, e1405 capture the reportable events of suicidal ideation, anxiety, scar tissue, dysuria, infection, nerve damage, inflammation, neuropathy, malaise, unspecified injury, bowel obstruction, pain, abdominal pain, dyspareunia.Impact code f1903 and f2303 capture the reportable events of medication required, partial removal of mesh.

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a robotic assisted rectopexy, endo adult esophagogastroduodenoscopy/flexible sigmoidoscopy, transvaginal urethral sling with cystoscopy and graft, mesh or fascia procedure performed on july 6, 2020, for the treatment of internal complete rectal prolapse with intussusception of rectosigmoid and stress urinary incontinence.Reportedly, the patient tolerated the procedure well and was taken to the recovery room in a stable condition.Immediately after the implantation, the patient woke up with a shooting pain in her vagina and the rectum, as if someone was poking it with the knife.On the right, this was a little more severe.She also experienced severe constipation.This pain was shooting down her back.The patient noticed that she could not wear any clothing that touched her skin in the perineal region.She also saw a physical therapist for the pelvic floor, who noted that her pelvic floor is quite tight.After that, the patient underwent a computerized tomography (ct) scan, which revealed a lump in the anastomosis region.She was unable to walk when she awoke the next morning, two days later.Reportedly, the lump pressing on her spinal cord was found to be an infection in her spinal cord.The patient received an intravenous vancomycin for a spinal cord infection during her two weeks in the hospital.Methicillin-resistant staphylococcus aureus was grown in the cultures.After taking antibiotics, she was eventually able to walk once more.The patient was informed that all of her meshes needed to be removed since they were infected.On (b)(6) 2021, the patient underwent a computed tomography (ct scan).During the procedure, it was revealed that there is a soft tissue thickening versus phlegmon at the level of the rectosigmoid anastomosis extending towards the right adnexa and sacrum along the rectocolpopexy.This may represent infection versus inflammation, less likely postsurgical scarring.Colonoscopy is recommended to rule out underlying mass lesion within the rectum.There was no contrast leak or drainable fluid collections noted.On (b)(6) 2021, the patient claims that despite taking antibiotics, she is still experiencing severe pelvic pain, back pain, and rectal pressure.She expresses her inability to elevate her legs due to pelvic and back pain.During bowel movements, she manually disintegrates stools.Her stools are hard and pellet-like, according to her.She then experiences 1-2 loose bowel motions after passing pellet-like feces.She says that her feces are occasionally red, but she denies any obvious bleeding.She denies having any urinary changes.She also denies having incontinence.She is given baclofen, which aids with stool evacuation.Additionally, the patient had rectosigmoid thickening of unknown cause on the computed tomography scan.They began the patient on antibiotics even though she did not have an abscess or an anastomotic leak, and the antibiotics did not seem to help.The doctor has advised her to obtain an urgent endoscopy to rule out an anastomosis problem, although considering that she is a year out, this would be exceptional in terms of developing a leak or abscess.She does not have significant proximal colon dilation, which would suggest stenosis, but the physician wants to rule that out with an endoscopy.According to the physician, the patient has significant pelvic floor dyssynergia and is still having significant difficulties evacuating stool.The patient will begin using a suppository containing lidocaine, flexeril, and diazepam to determine if it aids in the evacuation.She had previously taken baclofen orally, and it seemed to have helped.Finally, the physician has requested the patient to contact her primary care physician since she also complains of significant back pain at the level of the pelvis as well as sometimes difficulty moving her leg.The doctor thinks it is important for her to seek the advice of experts in other fields to rule out any possible causes of her pelvic pain.She seems to be on agreement with the plan.Moreover, a review of the systems is as follows during her consultation: gastrointestinal: positive for abdominal pain.Negative for blood in stool, constipation, diarrhea, heartburn, melena, nausea and vomiting.Genitourinary: negative for dysuria, flank pain, frequency, hematuria and urgency.Musculoskeletal: positive for back pain.Negative for falls, joint pain, myalgias and neck pain.On (b)(6) 2021, the patient sought for a medical attention for a potential sigmoid anastomosis leak and phlegmon.According to reports, the patient presented to occupational safety and health with bilateral lower extremity weakness caused by back pain and underwent magnetic resonance imaging (mri) to rule out l5-s1 discitis-osteomyelitis.Additionally, the computed tomography result revealed potential phlegmon at the rectosigmoid anastomosis, and she was started on flagyl.Furthermore, the general surgery department reviewed the results and found that no surgical treatments were necessary.According to infectious disease recommendations, the patient has been expanded to vancomycin and is awaiting a ct-guided bone marrow biopsy to help guide antibiotic therapy.The patient's gastrointestinal tract has been examined for the possibility of anastomotic phlegmon and infectious source sampling.Additionally, a computed tomography result date (b)(6) 2021, revealed an overall similar appearance of rectosigmoid inflammatory changes which extend towards the bilateral adnexa.These inflammatory changes are contiguous with presacral/prevertebral soft tissue thickening at the level of l5-s1.Prior to her procedure on (b)(6) 2021, the patient stated that she had developed increasing fatigue and back pain of unknown etiology over the previous several weeks.An extensive workup revealed that the patient had osteomyelitis at the l5s1 level (lumbosacral joint).On (b)(6) 2021, the patient underwent a laparoscopic removal of the sacrocolpopexy mesh, laparoscopic pelvic exploration, and proctoscopy, but there was no evidence that any of the advantage fit mesh was removed.The surgeon began the surgery and carried out an examination while sedated (laparoscopy).He then went on to remove the sacrocolpopexy mesh that had been in situ from the cervix to the sacrum.Additionally, he checked the bladder and did a cystoscopy.To ensure there was no damage to the colon, the surgeon scrubbed in and assisted with the pelvic mobilization laparoscopically.To make sure there was no leak from the anastomosis on the air-leak test, the surgeon performed proctoscopy while the anastomosis was submerged in saline in addition to laparoscopic inspection.The patient's pain persisted despite having her mesh removed.Because it was so severe, she was unable to engage in any sexual activity.She also experienced significant hesitancy and had difficulty urinating.Her doctor claimed that all the mesh had been taken out, but it looks like she still has a retropubic sling.The patient claims that the discomfort from the prolapse was nowhere near the severe pain she has been feeling lately.On (b)(6) 2021, the patient reported feeling well and experiencing only minor pain.She only needs gabapentin or naproxen when she has spent the entire day walking around the mall.The patient denies experiencing urinary issues, constipation, incontinence, or symptoms of recurrent prolapse.The patient also stated having a phone appointment with the doctor about her uncontrolled anxiety.She says, however, that her anxiety has lessened by 95% since she was able to see her children and refuses to take anxiety medication.According to reports, the patient was sent to the operating room on (b)(6) for mesh removal, and all mesh at the sacrum level was removed.The anastomosis was examined laparoscopically and found to be leak-free.Some mesh material, however, was retained and was embedded within the connective tissue.In addition, the patient states that she is doing significantly better after her discharge.She admits to having some pain, but it has greatly improved and is being managed with baclofen, celebrex, and gabapentin.The patient claims to be in pain, mild pain in the lower back, minimal pain in the upper back that feels like a muscle strain.Although the patient's wound looked to be healing nicely, she was still experiencing chills but no fevers or rigors.On (b)(6) 2021, the patient reports that she is doing well, although she notes that her back pain has gotten a little bit worse.She has been driving more and her car has bucket seats, which she thinks is responsible for her worsening pain.The pain is not nearly as bad as it was previously.Her upper back pain has resolved, although she sometimes experiences a pulling sensation when she wears a purse.She denies any weakness in her legs or any numbness or tingling.No bladder or bowel incontinence and no fevers or chills.Per discussion with urogyn, there is a residual mesh in between the bladder and vagina.All the mesh found near the spine was removed, though it is possible that some residual sutures and mesh remained that could not be found.The plan is to complete three months of therapy, including rifamycin, then will consider stopping versus a period of chronic suppression.The patient will eventually require lumbar interbody fusion.On (b)(6) 2021, the patient reports feeling very unwell.She is still experiencing from significant lower and midback pain.She is still experiencing diffuse abdominal discomfort and pain, as well as a pulling sensation in her abdomen.She recalls that her symptoms began to increase in july, before she stopped taking her oral antibiotics.In addition, she has experienced recurring abnormal stools that are fluffy or white and mucous-like, float and then sink, and at times are very stringy small caliber stools.She believes that something is obstructing her feces and that she must take an enema to make a bowel movement.This was also an issue before to her rectoplexy/sigmoidectomy in 2020, but it improved following surgery.She also claims that her acid reflux has worsened and that she has been vomiting every night.She is generally unwell, suffering from fatigue, malaise, and brain fog.There are no fevers, although there are occasional chills.On (b)(6) 2021, the patient experiences lower abdominal pain, mostly on the right side, and bloating that began around five to seven years ago.Her abdominal pain is dull and cramping, with the occasional sharp pain.She has abdominal pain a few times a week that lasts for varied amounts of time.She reports that bowel movements relieve her abdominal pain.She seems to have no recall of any events preceding the onset of abdominal pain and denies having undergone surgery, infection, or trauma.There were no particular food triggers found.She notices an increase in bloating after meals.A colonoscopy five to seven years ago revealed rectocele and vaginal prolapse.She had previously tried antacid medications without improvement.With regards to her bowel movements, she has one to three hard, ball-like stools in a day, though this can be variable in consistency.She also experiences the urge to have a bowel movement but then only sees mucous output.She reports straining and the sensation of incomplete evacuation.She takes miralax daily.She does not take fiber supplements due to abdominal cramping previously but tries to eat oatmeal daily.She uses a tap water or saline enema daily.She reports completing anorectal manometry testing in 2019 and biofeedback sessions in 2020 and most recently in (b)(6) 2021 with mild improvement in constipation.Moreover, the physician suspects her symptoms are likely multifactorial related to irritable bowel syndrome (given improvement with bowel movements), chronic constipation, and visceral hypersensitivity.Lower suspicion for iso, appendicitis, chronic pancreatitis (normal pancreas on imaging), peptic ulcer disease (no ulcers on recent ego), or malignancy.Although cholelithiasis was seen on computed tomography, her history does not sound consistent with biliary colic.We recommend a colonoscopy for further evaluation to see if the active colitis has resolved, and she is also due for colon cancer screening.With regards to her acid reflux and regurgitation symptoms, she has a history of nissen fundoplication.They recommend a trial of maximal acid suppression for treatment of gastroesophageal reflux disease (gerd) with increasing proton pump inhibitor dosing to twice daily dosing.Given her symptoms of dysphagia to solids, they advise her to have esophageal biopsies and gastric biopsies repeated to rule out esophageal eosinophilic esophagitis (eoe).If esophageal biopsies are unremarkable and she experiences no improvement on proton pump inhibitor, they can consider further work up with manometry to evaluate for motility disorders and ph testing to determine severity of reflux and whether her symptoms acid reflux.On (b)(6) 2021, the patient presented to the clinic for evaluation of severe defecatory dysfunction symptoms.As a result, the patient seeks a second opinion.The patient also claims to have a mesh infection and thus to digitally remove her bowel movements.According to reports, the patient is frustrated by her symptoms.She was presented with the choice of undergoing back surgery for rod placement due to l5-s1 discitis osteomyelitis.She is also frustrated by bowel movements that need digitation and enemas, and she wonders if this should be addressed prior to any spine surgery.The patient complained of pelvic pain on (b)(6) 2022.The report states that there is bilateral lower back tenderness, significant lower abdomen tenderness, a positive carnett's sign, intense pelvic floor muscle tenderness, and extremely painful mid-urethral tenderness at the location where the sling was applied.In addition, the following was the doctor's evaluation at the patient's consultation: causalgia of bilateral lower limbs pudendal neuralgia spastic pelvic floor syndrome.The patient and the surgeon had a long discussion.According to reports, the patient was pain-free before the advantage fit suburethral retropubic sling was applied.The patient woke up in the recovery room with sever neuropathic pain in her perineal area just after the sling was put on.Her anastomotic leak following bowel surgery, which most likely infected her sacralcervicopexy mesh, came after she was told it would get better with time.The patient was given a lengthy course of vancomycin treatment before being eventually transported back to the operating room, when the sacralcervicopexy mesh was reportedly removed.Unfortunately, she was still in pain after doing this.Reportedly, when sitting, the patient's pain is severe.She experiences pain during sex to the extent that she refrains from sexual activity and worries about her marriage.She is hesitant and constipated.Due to her sensitivities, she is unable to wear tight pants, and the pain is so severe that she has occasionally thought she does not want to live.Subsequently, they have opted to take out the superior fit mesh after much deliberation.A burch technique is not advised by the surgeon due to the possibility of gore-tex sutures becoming contaminated.The patient would also undergo a bilateral pudendal nerve block and a pelvic floor muscle botox injection.Reportedly, the patient will be a candidate for an injection of amniofix into both pudendal nerves if there is no improvement, and she may also need a continuous on-q pain pump to lower her central nervous system activity.The patient might also be a candidate for a bilateral trans-gluteal pudendal neurolysis if those treatments don't work.The surgeon and patient and had a thorough discussion about everything.The patient understands and wishes to proceed with mesh removal.On (b)(6) 2022, the patient underwent the following procedure for the treatment of implanted vaginal mesh complication, spastic pelvic floor syndrome and pudendal neuralgia.Vaginal removal of vaginal sling robotic assisted laparoscopic removal of sling arms robotic assisted laparoscopic removal of sacrocolpopexy mesh bilateral pudendal nerve block botox injection to pelvic floor muscles cystoscopy.Using 20 ml of 0.5% bupivacaine and adrenaline, the initial bilateral pudendal nerve block was performed during the procedure.10 ml were injected into each ischial spine using a pudendal nerve block needle.20 ml of regular sterile saline were used to dilute 200 units of botulinum toxin a.It was administered bilaterally into the pelvic floor muscles 20 times with a volume of 1 ml each using a pudendal nerve block needle.It was injected into eight muscles.A weighted speculum was also inserted into the vagina, and the lonestar retractor was utilized to reveal the surgical site.Ten milliliters of 0.5% marcaine with epinephrine were injected into the anterior vaginal wall.After making a small vertical incision in the anterior vaginal wall, a white polypropylene sling was noticed.It was detached from the surrounding vaginal tissues and underlying urethra.This sling was divided down the middle, and two kocher clamps were attached to each end when it was discovered to be free all the way behind the pubic ramus.The robotic component of the process then caught their attention.As usual, robotic ports were placed.The results of the evaluation of the abdomen and pelvis are mentioned above.The sigmoid colon was strongly adhered to the presacral region.The cervix was present and had two areas of white mesh that were clearly visible--one in the front and one in the back.The bladder and rectum were detached from the cervix using sharp and blunt dissection, and the two pieces of the previous sacral cervicopexy mesh were taken out and transferred.There was some bleeding there, but arista and floseal were able to stop it.Their attention then turned to the exploration of the retropubic area.The sigmoid colon reportedly had strong adhesions to the presacral region.The sigmoid colon was moved away from the presacral region using meticulous sharp and blunt dissection.The anterior longitudinal ligament was observed, and the aortic bifurcation could be seen.No mesh or sutures were visible in this region.Their attention then turned to the removal of retropubic mesh.Moreover, a 400ml of regular sterile saline was placed in the bladder.The retropubic space was then accessed entered through an incision in the peritoneum anterior to the bladder.Bipolar cautery was used to control bleeding from tiny vessels.It was possible to see the left side of the retropubic mesh against the pubic bone's backside.It was discovered to be in its proper place.The mesh was dissected toward the anterior abdominal wall with meticulous and time-consuming dissection, and the entire piece, including the portion in the rectus abdominis muscle, was removed.It was then dissected towards the pelvic floor until the entry of the mesh through the anterior attachment of the levator muscle.The kocher clamp attached to the vaginal portion of the mesh on the left side was then pushed into the pelvis and the entire piece of mesh was dissected out.Excellent hemostasis was noted.The mesh on the right side was then identified.It was also found to be in the correct position.The entire mesh on the right side was removed in an identical manner to the removal of the left mesh.The entire area was irrigated, and arista was used to obtain excellent hemostasis.Furthermore, the on-q pain pump catheter was then placed in the retropubic space and connected to the pump filled with 0.2% ropivacaine.It was set to run at 6 ml/h.The fascia of the umbilical port was closed with 0 vicryl and the skin of all ports was closed with 4-0 monocryl.Small openings in the pelvic floor muscles were closed with 3-0 vicryl bilaterally and the vaginal epithelium was closed with a running suture of 3-0 vicryl.Cystoscopy was performed and no injuries to the bladder or urethra were noted.This concluded the procedure.The patient tolerated the procedure well.She was taken to the recovery room in stable condition.Boston scientific received an additional information on november 4, 2020 as follows: the patient had a computed tomography (ct) of the pelvis with contrast on (b)(6) 2021.Contiguous 1.25-mm collimation axial images were taken through the abdomen and pelvis after 150 cc of omnipaque 350 was administered.Reformats of the corona and sagita were also obtained.The following are some of the procedure's findings: following sacral colpopexy and supracervical hysterectomy, a decrease in pelvic inflammatory changes is concerning because the infection has improved but is still persistent.A drainable abscess was observed.Postsurgical changes in the sigmoid colon are again seen with surrounding fat stranding and confluent edema extending to the bilateral pelvic sidewalls.There is no loculated collection to indicate an abscess.The right pelvic appendix is nondistended, with the tip terminating within the area of inflammatory change.A small to moderate hiatal hernia with prior fundoplication changes.Significant improvement in left iliac chain lengths greater than right iliac chain lengths, as well as presacral and perirectal enlarged lymph nodes.Status after supracervical hysterectomy and sacral colpopexy, as well as previously seen ill-defined hyperattenuating foci at the cervical cuff apex, to be resolved.L5-s1 discitis osteomyelitis-like sequelae with slight interval decreases in adjacent inflammatory change.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of july 6, 2020, 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 implanting surgeons are: (b)(6).Explanting surgeon: (b)(6).Block h6: patient code e0205, e020201, e1715, e1301, e1906, e0123, e2326, e2326, e020204, e2401, e2328, e2330, e1002, e1405 capture the reportable events of suicidal ideation, anxiety, scar tissue, dysuria, infection, nerve damage, inflammation, neuropathy, malaise, unspecified injury, bowel obstruction, pain, abdominal pain, dyspareunia.Impact code f1903 and f2303 capture the reportable events of medication required, partial removal of mesh.Block h11: blocks b5, e1, h6 and h10 have been updated based on the additional information received on february 7, 2023.Block h6: patient code e172001 was utilized to capture the reportable event of abscess.Patient code e2328 was utilized to capture the reportable event of obstruction.Patient code e2330 was utilized to capture the reportable event of pain.Patient code e1002 was utilized to capture the reportable event of abdominal pain.Patient code e1405 was utilized to capture the reportable event of dyspareunia.Patient code e020201 was utilized to capture the reportable event of anxiety.Patient code e1301 was utilized to capture the reportable event of dysuria.Patient code e1906 was utilized to capture the reportable event of infection.Patient code e2326 was utilized to capture the reportable event of inflammation.Patient code e020204 was utilized to capture the reportable event of malaise.Patient code e2401 was utilized to capture the reportable event of injury.Patient code e231501 was utilized to capture the reportable event of yellow discharge in rectum.Patient code e1621 was utilized to capture the reportable event of weakness.Patient code e0205 was utilized to capture the reportable event of suicidal ideation.Patient code e1715 was utilized to capture the reportable event of scar tissue.Patient code e1715 was utilized to capture the reportable event of nerve damage.Patient code e0126 was utilized to capture the reportable event of neuropathy.Patient code e0506 was utilized to capture the reportable event of hemorrhage.Impact code f1903 captures the reportable event of partial removal of mesh.Impact code f2303 captures the reportable event of medication required.Impact code f08 captures the reportable event of patient's hospital admission.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a robotic assisted rectopexy, endo adult esophagogastroduodenoscopy/flexible sigmoidoscopy, transvaginal urethral sling with cystoscopy and graft, mesh or fascia procedure performed on (b)(6) 2020, for the treatment of internal complete rectal prolapse with intussusception of rectosigmoid and stress urinary incontinence.Reportedly, the patient tolerated the procedure well and was taken to the recovery room in a stable condition.Immediately after the implantation, the patient woke up with a shooting pain in her vagina and the rectum, as if someone was poking it with the knife.On the right, this was a little more severe.She also experienced severe constipation.This pain was shooting down her back.The patient noticed that she could not wear any clothing that touched her skin in the perineal region.She also saw a physical therapist for the pelvic floor, who noted that her pelvic floor is quite tight.After that, the patient underwent a computerized tomography (ct) scan, which revealed a lump in the anastomosis region.She was unable to walk when she awoke the next morning, two days later.Reportedly, the lump pressing on her spinal cord was found to be an infection in her spinal cord.The patient received an intravenous vancomycin for a spinal cord infection during her two weeks in the hospital.Methicillin-resistant staphylococcus aureus was grown in the cultures.After taking antibiotics, she was eventually able to walk once more.The patient was informed that all of her meshes needed to be removed since they were infected.On (b)(6) 2021, the patient underwent a computed tomography (ct scan).During the procedure, it was revealed that there is a soft tissue thickening versus phlegmon at the level of the rectosigmoid anastomosis extending towards the right adnexa and sacrum along the rectocolpopexy.This may represent infection versus inflammation, less likely postsurgical scarring.Colonoscopy is recommended to rule out underlying mass lesion within the rectum.There was no contrast leak or drainable fluid collections noted.On (b)(6) 2021, the patient claims that despite taking antibiotics, she is still experiencing severe pelvic pain, back pain, and rectal pressure.She expresses her inability to elevate her legs due to pelvic and back pain.During bowel movements, she manually disintegrates stools.Her stools are hard and pellet-like, according to her.She then experiences 1-2 loose bowel motions after passing pellet-like feces.She says that her feces are occasionally red, but she denies any obvious bleeding.She denies having any urinary changes.She also denies having incontinence.She is given baclofen, which aids with stool evacuation.Additionally, the patient had rectosigmoid thickening of unknown cause on the computed tomography scan.They began the patient on antibiotics even though she did not have an abscess or an anastomotic leak, and the antibiotics did not seem to help.The doctor has advised her to obtain an urgent endoscopy to rule out an anastomosis problem, although considering that she is a year out, this would be exceptional in terms of developing a leak or abscess.She does not have significant proximal colon dilation, which would suggest stenosis, but the physician wants to rule that out with an endoscopy.According to the physician, the patient has significant pelvic floor dyssynergia and is still having significant difficulties evacuating stool.The patient will begin using a suppository containing lidocaine, flexeril, and diazepam to determine if it aids in the evacuation.She had previously taken baclofen orally, and it seemed to have helped.Finally, the physician has requested the patient to contact her primary care physician since she also complains of significant back pain at the level of the pelvis as well as sometimes difficulty moving her leg.The doctor thinks it is important for her to seek the advice of experts in other fields to rule out any possible causes of her pelvic pain.She seems to be on agreement with the plan.Moreover, a review of the systems is as follows during her consultation: **gastrointestinal: positive for abdominal pain.Negative for blood in stool, constipation, diarrhea, heartburn, melena, nausea and vomiting.**genitourinary: negative for dysuria, flank pain, frequency, hematuria and urgency.**musculoskeletal: positive for back pain.Negative for falls, joint pain, myalgias and neck pain.On (b)(6) 2021, the patient sought for a medical attention for a potential sigmoid anastomosis leak and phlegmon.According to reports, the patient presented to occupational safety and health with bilateral lower extremity weakness caused by back pain and underwent magnetic resonance imaging (mri) to rule out l5-s1 discitis-osteomyelitis.Additionally, the computed tomography result revealed potential phlegmon at the rectosigmoid anastomosis, and she was started on flagyl.Furthermore, the general surgery department reviewed the results and found that no surgical treatments were necessary.According to infectious disease recommendations, the patient has been expanded to vancomycin and is awaiting a ct-guided bone marrow biopsy to help guide antibiotic therapy.The patient's gastrointestinal tract has been examined for the possibility of anastomotic phlegmon and infectious source sampling.Additionally, a computed tomography result date (b)(6) 2021, revealed an overall similar appearance of rectosigmoid inflammatory changes which extend towards the bilateral adnexa.These inflammatory changes are contiguous with presacral/prevertebral soft tissue thickening at the level of l5-s1.Prior to her procedure on (b)(6) 2021, the patient stated that she had developed increasing fatigue and back pain of unknown etiology over the previous several weeks.An extensive workup revealed that the patient had osteomyelitis at the l5s1 level (lumbosacral joint).On (b)(6) 2021, the patient underwent a laparoscopic removal of the sacrocolpopexy mesh, laparoscopic pelvic exploration, and proctoscopy, but there was no evidence that any of the advantage fit mesh was removed.The surgeon began the surgery and carried out an examination while sedated (laparoscopy).He then went on to remove the sacrocolpopexy mesh that had been in situ from the cervix to the sacrum.Additionally, he checked the bladder and did a cystoscopy.To ensure there was no damage to the colon, the surgeon scrubbed in and assisted with the pelvic mobilization laparoscopically.To make sure there was no leak from the anastomosis on the air-leak test, the surgeon performed proctoscopy while the anastomosis was submerged in saline in addition to laparoscopic inspection.The patient's pain persisted despite having her mesh removed.Because it was so severe, she was unable to engage in any sexual activity.She also experienced significant hesitancy and had difficulty urinating.Her doctor claimed that all the mesh had been taken out, but it looks like she still has a retropubic sling.The patient claims that the discomfort from the prolapse was nowhere near the severe pain she has been feeling lately.On (b)(6) 2021, the patient reported feeling well and experiencing only minor pain.She only needs gabapentin or naproxen when she has spent the entire day walking around the mall.The patient denies experiencing urinary issues, constipation, incontinence, or symptoms of recurrent prolapse.The patient also stated having a phone appointment with the doctor about her uncontrolled anxiety.She says, however, that her anxiety has lessened by 95% since she was able to see her children and refuses to take anxiety medication.According to reports, the patient was sent to the operating room on may 3 for mesh removal, and all mesh at the sacrum level was removed.The anastomosis was examined laparoscopically and found to be leak-free.Some mesh material, however, was retained and was embedded within the connective tissue.In addition, the patient states that she is doing significantly better after her discharge.She admits to having some pain, but it has greatly improved and is being managed with baclofen, celebrex, and gabapentin.The patient claims to be in pain, mild pain in the lower back, minimal pain in the upper back that feels like a muscle strain.Although the patient's wound looked to be healing nicely, she was still experiencing chills but no fevers or rigors.On (b)(6) 2021, the patient reports that she is doing well, although she notes that her back pain has gotten a little bit worse.She has been driving more and her car has bucket seats, which she thinks is responsible for her worsening pain.The pain is not nearly as bad as it was previously.Her upper back pain has resolved, although she sometimes experiences a pulling sensation when she wears a purse.She denies any weakness in her legs or any numbness or tingling.No bladder or bowel incontinence and no fevers or chills.Per discussion with urogyn, there is a residual mesh in between the bladder and vagina.All the mesh found near the spine was removed, though it is possible that some residual sutures and mesh remained that could not be found.The plan is to complete three months of therapy, including rifamycin, then will consider stopping versus a period of chronic suppression.The patient will eventually require lumbar interbody fusion.On (b)(6) 2021, the patient reports feeling very unwell.She is still experiencing from significant lower and midback pain.She is still experiencing diffuse abdominal discomfort and pain, as well as a pulling sensation in her abdomen.She recalls that her symptoms began to increase in july, before she stopped taking her oral antibiotics.In addition, she has experienced recurring abnormal stools that are fluffy or white and mucous-like, float and then sink, and at times are very stringy small caliber stools.She believes that something is obstructing her feces and that she must take an enema to make a bowel movement.This was also an issue before to her rectoplexy/sigmoidectomy in 2020, but it improved following surgery.She also claims that her acid reflux has worsened and that she has been vomiting every night.She is generally unwell, suffering from fatigue, malaise, and brain fog.There are no fevers, although there are occasional chills.On (b)(6) 2021, the patient experiences lower abdominal pain, mostly on the right side, and bloating that began around five to seven years ago.Her abdominal pain is dull and cramping, with the occasional sharp pain.She has abdominal pain a few times a week that lasts for varied amounts of time.She reports that bowel movements relieve her abdominal pain.She seems to have no recall of any events preceding the onset of abdominal pain and denies having undergone surgery, infection, or trauma.There were no particular food triggers found.She notices an increase in bloating after meals.A colonoscopy five to seven years ago revealed rectocele and vaginal prolapse.She had previously tried antacid medications without improvement.With regards to her bowel movements, she has one to three hard, ball-like stools in a day, though this can be variable in consistency.She also experiences the urge to have a bowel movement but then only sees mucous output.She reports straining and the sensation of incomplete evacuation.She takes miralax daily.She does not take fiber supplements due to abdominal cramping previously but tries to eat oatmeal daily.She uses a tap water or saline enema daily.She reports completing anorectal manometry testing in 2019 and biofeedback sessions in 2020 and most recently in (b)(6) 2021 with mild improvement in constipation.Moreover, the physician suspects her symptoms are likely multifactorial related to irritable bowel syndrome (given improvement with bowel movements), chronic constipation, and visceral hypersensitivity.Lower suspicion for iso, appendicitis, chronic pancreatitis (normal pancreas on imaging), peptic ulcer disease (no ulcers on recent ego), or malignancy.Although cholelithiasis was seen on computed tomography, her history does not sound consistent with biliary colic.We recommend a colonoscopy for further evaluation to see if the active colitis has resolved, and she is also due for colon cancer screening.With regards to her acid reflux and regurgitation symptoms, she has a history of nissen fundoplication.They recommend a trial of maximal acid suppression for treatment of gastroesophageal reflux disease (gerd) with increasing proton pump inhibitor dosing to twice daily dosing.Given her symptoms of dysphagia to solids, they advise her to have esophageal biopsies and gastric biopsies repeated to rule out esophageal eosinophilic esophagitis (eoe).If esophageal biopsies are unremarkable and she experiences no improvement on proton pump inhibitor, they can consider further work up with manometry to evaluate for motility disorders and ph testing to determine severity of reflux and whether her symptoms acid reflux.On (b)(6) 2021, the patient presented to the clinic for evaluation of severe defecatory dysfunction symptoms.As a result, the patient seeks a second opinion.The patient also claims to have a mesh infection and thus to digitally remove her bowel movements.According to reports, the patient is frustrated by her symptoms.She was presented with the choice of undergoing back surgery for rod placement due to l5-s1 discitis osteomyelitis.She is also frustrated by bowel movements that need digitation and enemas, and she wonders if this should be addressed prior to any spine surgery.The patient complained of pelvic pain on (b)(6) 2022.The report states that there is bilateral lower back tenderness, significant lower abdomen tenderness, a positive carnett's sign, intense pelvic floor muscle tenderness, and extremely painful mid-urethral tenderness at the location where the sling was applied.In addition, the following was the doctor's evaluation at the patient's consultation: causalgia of bilateral lower limbs.Pudendal neuralgia.Spastic pelvic floor syndrome.The patient and the surgeon had a long discussion.According to reports, the patient was pain-free before the advantage fit suburethral retropubic sling was applied.The patient woke up in the recovery room with sever neuropathic pain in her perineal area just after the sling was put on.Her anastomotic leak following bowel surgery, which most likely infected her sacralcervicopexy mesh, came after she was told it would get better with time.The patient was given a lengthy course of vancomycin treatment before being eventually transported back to the operating room, when the sacralcervicopexy mesh was reportedly removed.Unfortunately, she was still in pain after doing this.Reportedly, when sitting, the patient's pain is severe.She experiences pain during sex to the extent that she refrains from sexual activity and worries about her marriage.She is hesitant and constipated.Due to her sensitivities, she is unable to wear tight pants, and the pain is so severe that she has occasionally thought she does not want to live.Subsequently, they have opted to take out the superior fit mesh after much deliberation.A burch technique is not advised by the surgeon due to the possibility of gore-tex sutures becoming contaminated.The patient would also undergo a bilateral pudendal nerve block and a pelvic floor muscle botox injection.Reportedly, the patient will be a candidate for an injection of amniofix into both pudendal nerves if there is no improvement, and she may also need a continuous on-q pain pump to lower her central nervous system activity.The patient might also be a candidate for a bilateral trans-gluteal pudendal neurolysis if those treatments don't work.The surgeon and patient and had a thorough discussion about everything.The patient understands and wishes to proceed with mesh removal.On (b)(6) 2022, the patient underwent the following procedure for the treatment of implanted vaginal mesh complication, spastic pelvic floor syndrome and pudendal neuralgia.Vaginal removal of vaginal sling.Robotic assisted laparoscopic removal of sling arms.Robotic assisted laparoscopic removal of sacrocolpopexy mesh.Bilateral pudendal nerve block.Botox injection to pelvic floor muscles.Cystoscopy.Using 20 ml of 0.5% bupivacaine and adrenaline, the initial bilateral pudendal nerve block was performed during the procedure.10 ml were injected into each ischial spine using a pudendal nerve block needle.20 ml of regular sterile saline were used to dilute 200 units of botulinum toxin a.It was administered bilaterally into the pelvic floor muscles 20 times with a volume of 1 ml each using a pudendal nerve block needle.It was injected into eight muscles.A weighted speculum was also inserted into the vagina, and the lonestar retractor was utilized to reveal the surgical site.Ten milliliters of 0.5% marcaine with epinephrine were injected into the anterior vaginal wall.After making a small vertical incision in the anterior vaginal wall, a white polypropylene sling was noticed.It was detached from the surrounding vaginal tissues and underlying urethra.This sling was divided down the middle, and two kocher clamps were attached to each end when it was discovered to be free all the way behind the pubic ramus.The robotic component of the process then caught their attention.As usual, robotic ports were placed.The results of the evaluation of the abdomen and pelvis are mentioned above.The sigmoid colon was strongly adhered to the presacral region.The cervix was present and had two areas of white mesh that were clearly visible--one in the front and one in the back.The bladder and rectum were detached from the cervix using sharp and blunt dissection, and the two pieces of the previous sacral cervicopexy mesh were taken out and transferred.There was some bleeding there, but arista and floseal were able to stop it.Their attention then turned to the exploration of the retropubic area.The sigmoid colon reportedly had strong adhesions to the presacral region.The sigmoid colon was moved away from the presacral region using meticulous sharp and blunt dissection.The anterior longitudinal ligament was observed, and the aortic bifurcation could be seen.No mesh or sutures were visible in this region.Their attention then turned to the removal of retropubic mesh.Moreover, a 400ml of regular sterile saline was placed in the bladder.The retropubic space was then accessed entered through an incision in the peritoneum anterior to the bladder.Bipolar cautery was used to control bleeding from tiny vessels.It was possible to see the left side of the retropubic mesh against the pubic bone's backside.It was discovered to be in its proper place.The mesh was dissected toward the anterior abdominal wall with meticulous and time-consuming dissection, and the entire piece, including the portion in the rectus abdominis muscle, was removed.It was then dissected towards the pelvic floor until the entry of the mesh through the anterior attachment of the levator muscle.The kocher clamp attached to the vaginal portion of the mesh on the left side was then pushed into the pelvis and the entire piece of mesh was dissected out.Excellent hemostasis was noted.The mesh on the right side was then identified.It was also found to be in the correct position.The entire mesh on the right side was removed in an identical manner to the removal of the left mesh.The entire area was irrigated, and arista was used to obtain excellent hemostasis.Furthermore, the on-q pain pump catheter was then placed in the retropubic space and connected to the pump filled with 0.2% ropivacaine.It was set to run at 6 ml/h.The fascia of the umbilical port was closed with 0 vicryl and the skin of all ports was closed with 4-0 monocryl.Small openings in the pelvic floor muscles were closed with 3-0 vicryl bilaterally and the vaginal epithelium was closed with a running suture of 3-0 vicryl.Cystoscopy was performed and no injuries to the bladder or urethra were noted.This concluded the procedure.The patient tolerated the procedure well.She was taken to the recovery room in stable condition.Boston scientific received an additional information on november 4, 2020 as follows: the patient had a computed tomography (ct) of the pelvis with contrast on (b)(6) 2021.Contiguous 1.25-mm collimation axial images were taken through the abdomen and pelvis after 150 cc of omnipaque 350 was administered.Reformats of the corona and sagita were also obtained.The following are some of the procedure's findings: following sacral colpopexy and supracervical hysterectomy, a decrease in pelvic inflammatory changes is concerning because the infection has improved but is still persistent.A drainable abscess was observed.Postsurgical changes in the sigmoid colon are again seen with surrounding fat stranding and confluent edema extending to the bilateral pelvic sidewalls.There is no loculated collection to indicate an abscess.The right pelvic appendix is nondistended, with the tip terminating within the area of inflammatory change.A small to moderate hiatal hernia with prior fundoplication changes.Significant improvement in left iliac chain lengths greater than right iliac chain lengths, as well as presacral and perirectal enlarged lymph nodes.Status after supracervical hysterectomy and sacral colpopexy, as well as previously seen ill-defined hyperattenuating foci at the cervical cuff apex, to be resolved.L5-s1 discitis osteomyelitis-like sequelae with slight interval decreases in adjacent inflammatory change.Additional information received on february 7, 2023: on (b)(6) 2021, the patient presented to the emergency department due to a history of chronic pelvic floor dysfunction, pelvic organ prolapse, and recurrent rectal prolapse status post sigmoid resection and robotic rectopexy performed in (b)(6) 2020 and a repeat robotic rectopexy and transverse urethral sling in (b)(6) 2020.The patient was recently admitted from (b)(6) 2021 for complaints of lower back pain and she was found to have rectosigmoid phlegmon and l5-s1 osteomyelitis.She was now readmitted for continued lower back pain, rle weakness, and a new onset of urinary incontinence with plans for removal of infected sacral-colopexy mesh.In the physician's assessment the mesh used for sacrocolpopexy was likely infected when the patient had leakage from her sigmoid anastomosis.The mesh needs to be removed to allow optimal conditions for the healing of the patient's osteomyelitis.A complete review of systems was performed and revealed that the patient was experiencing chills, urinary incontinence, and lower back and abdominal pain.The patients complete blood count revealed that the patient had a low hemoglobin count at 9.8, low hematocrit at 32,4, low albumin serum/plasma at 2,7 and low total calcium serum/plasma at 8.2.On (b)(6) 2021, the patient underwent a robotic assisted excision of mesh to treat the patients' osteomyelitis with concern for infected mesh.Pre-operative diagnosis includes infected prosthetic mesh of abdominal wall, sequela.There were no patient complications reported after the procedure and the patient was discharged on (b)(6) 2021.On (b)(6) 2022, the patent presented at the emergency department (ed) with complaints of rectal pain and obstructive defecation.The patient was unable to have a decent bowel movement in five days.The patient reported that she ran out of oxycodone and has not been able to have a bowel movement because of the severe pain.Upon review of systems, it was noted that the patient was experiencing abdominal pain, nausea and headache.It was also noted that the patient's abdomen was distended and tender.The patient also had external hemorrhoids which were soft, normal in color and no bleeding nor fissures were noted.The patient was prescribed with oxycodone and she felt improved in the ed after taking the medication.The patient felt comfortable with plan for discharge and precautions were discussed.On (b)(6) 2022, the patient presented at the emergency department (ed) tearful and complained of a 10/10 pain.The patient reported abscesses in here rectum and reported to have yellow discharge.The patient also reported to have fevers at home.They were able to limitedly assess the patient due to the patient's cooperation level.Upon review of systems, the patient was positive for fever.Gastrointestinal review revealed that the patient had abdominal pain, anal bleeding, blood in stool, constipation, nausea and rectal pain.The patient also had abdominal tenderness with guarding.In the physician's assessment, the patient's metabolic work-up was overall reassuring.The patient declined rectal examination due to severe pain but did have what appeared to be external hemorrhoids on exam.The patient's symptoms did not appear to abate with 10mg of home oxycodone.The patient underwent a ct scan which showed no acute findings.The patient required multiple doses of iv dilaudid pain medication for rectal pain.A rectal enema was offered but the patient declined due to severe rectal pain.

• Brand Name: ADVANTAGE FIT SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14628284
• MDR Text Key: 294136729
• Report Number: 3005099803-2022-03186
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 0025306457
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• 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): Required Intervention; Other
• Patient Age: 44 YR
• Patient Sex: Female