MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

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Model Number M0068507010

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

Patient Problems Wound Dehiscence (1154); Erosion (1750); Micturition Urgency (1871); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Depression (2361); Prolapse (2475); Sleep Dysfunction (2517); Dyspareunia (4505); Sexual Dysfunction (4510); Unspecified Musculoskeletal problem (4535); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 06/12/2020

Event Type Injury

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2020, implant date, as no event date was reported.This event was reported by the patient's legal representation.The reported healthcare facility was: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Manufacturer Narrative

Block b3 date of event: date of event was approximated to june 12, 2020, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The attending physician is: (b)(6).The surgeon is: (b)(6).Block h6: patient code e2326, e1405, e2006, e2330, e0123, e020201 and e2340 captures the reportable event of inflammation, dyspareunia, erosion, pain, nerve damage, anxiety and wound dehiscence.Impact code f1903 captures the reportable event of mesh removal.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 failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Manufacturer Narrative

Block h2: blocks b5 and h6 have been updated based on additional information received on february 2, 2022.Block b3 date of event: date of event was approximated to (b)(6) 2020, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The physician's are: (b)(6).Dr.(b)(6).Dr.(b)(6) block h6: patient code e2326, e1405, e2006, e2330, e0123, e020201, e2340 and e020202 captures the reportable events of inflammation, dyspareunia, erosion, pain, nerve damage, anxiety, wound dehiscence and depression.Impact code f1903 captures the reportable event of mesh removal.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 failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Manufacturer Narrative

Correction to block b5 block b3 date of event: date of event was approximated to june 12, 2020, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The physician's are: (b)(6) block h6: patient code e2326, e1405, e2006, e2330, e0123, e020201, e2340 and e020202 captures the reportable events of inflammation, dyspareunia, erosion, pain, nerve damage, anxiety, wound dehiscence and depression.Impact code f1903 captures the reportable event of mesh removal.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 failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Block h2: block b5 and h6 have been updated based on additional information received on march 23, 2022.Block b3 date of event: date of event was approximated to june 12, 2020, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The physician's are: dr.(b)(6).Block h6: patient code e2326, e1405, e2006, e2330, e0123, e020201, e2340, e020202 and e1715 captures the reportable events of inflammation, dyspareunia, erosion, pain, nerve damage, anxiety, wound dehiscence, depression and scar tissue.Impact code f1903 captures the reportable event of mesh removal.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 failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Boston scientific corporation received additional information on january 14, 2022 as follows: medical and surgical history included mixed urinary incontinence, dyspareunia and perineal pain (noted to have a ridge along the hymenal ring which was painful to the touch; perineal pain unresponsive to massage with lidocaine), obesity, herpes encephalitis, low grade squamous intraepithelial dysplasia, multiple colposcopies, cervical biopsy with loop excision, migraines, panic disorder, episodic mood disorder, generalized anxiety disorder, depression, meningitis, smoking, and cholecystectomy.On (b)(6) 2020, the patient underwent a pubovaginal sling procedure for the treatment of stress incontinence.Cystourethroscopy performed after sling placement revealed submucosal blue mesh without evidence of any injury to the bladder.The foley catheter was reinserted and then the right side of the mesh and anchor was loosened and repositioned.Repeat cystoscopy showed that the mesh was no longer in the bladder submucosa.Post-procedure, the patient was taken to the recovery room in a stable condition.On (b)(6) 2020, the patient went for a follow-up visit.The patient reported 70-80 percent reduction in stress urinary incontinence after the sling implantation.The patient is on vesicare with improved frequency and urgency.The patient reports leaks occasionally with laugh, sneeze and picking up of children.Exam revealed no exposed or palpable mesh and no bleeding from the incision.Slight leakage was noted with coughing and bearing down.On (b)(6) 2020, the patient reportedly underwent an excision of scar along the hymenal ring that was thought to be due to scarring from perineal laceration after her vaginal delivery.On (b)(6) 2020, at her postoperative appointment, the patient was doing well and had no pain.In addition, the patient reported that she would be seen by the urology service on (b)(6) 2020 for urinary incontinence and erosion of mesh.She was wearing pads continuously.During pelvic examination, the patient is noted to have a leakage of urine.The perineum and posterior vagina was noted to have a mild separation of wound.The exposed suture was clipped and the wound remained intact.The mesh was not visible but the edges were palpable.The physician was concerned about the constant pad use and how it was impacting her wound healing.She was advised to keep the area clean and as dry as possible.The patient was advised to resume all regular activities as tolerated.Patient to continue pelvic rest with limited activities, no heavy lifting or strenuous exercise.On (b)(6) 2020, went for a follow-up visit.The patient reports exposed mesh.She had a vaginoplasty surgery 2 weeks ago that removed some exposed mesh but then saw more exposure on a post-op check on (b)(6) 2020.The patient still leaks occasionally with laugh, sneeze and picking up of children.Exam revealed the mesh was difficult to see but was palpable.There was no discharge or bleeding.The patient was advised to follow up in 3 weeks.On (b)(6) 2020, the patient underwent an excision of vaginal mesh and cystourethroscopy.The operative report notes the surgeon attempted to release the mesh from its anchors in the pelvic sidewall but was unsuccessful because of the well incorporated portions of mesh in the deeper layers.The mesh was traced back as far laterally on the right side as possible and then excised with sharp scissors.The same was done on the left side.The mesh was removed.The patient tolerated the procedure well and was taken to the recovery room in a stable condition.On (b)(6) 2020, the patient went for a postoperative follow-up visit.During the examination, the vaginal anterior wall was intact.No discoloration or bleeding noted.Cystocele is not present.On (b)(6) 2020, the patient presents for follow-up.The patient reports that she is doing well and the incision site feels much better.Her incontinence is still persistent.The patient is frustrated regarding her recovery and outcome from her urologic procedure.Exam showed a well healed incision site, no palpable tenderness along the scar, and sutures intact anteriorly from mesh removal.The patient was interested in alternative options for management of her incontinence, and she was referred to urogynecology.On (b)(6) 2021, the patient presented with chronic pelvic pain syndrome, vaginismus, and pelvic floor hypertonia with pudendal nerve involvement (noted on (b)(6) 2020).The patient reported pain at the vagina, bilateral perineum that feels like a "golf ball sensation" and bilateral thighs since 3 weeks post sling procedure; urinary urgency and frequency and sometimes "doesn't make it to the bathroom in time; pain with vaginal penetration; pain that is worse with sitting.Predisposing factors were noted as anxiety/depression; a history of heavy, painful and irregular menses; and status post sling removal on (b)(6) 2020 after vaginal wall mesh erosion.The patient states she saw her obgyn who was reportedly concerned about nerve damage.Currently, the patient rates her symptoms 9 of 10 and describes them as stabbing.The plan was pelvic floor physical therapy (pfpt) 1-2x / week or 8-12 weeks for pelvic floor hypertonia.Boston scientific corporation received additional information on february 2, 2022 as follows: on (b)(6) 2020, the patient underwent a psychotherapy.The patient presents a slight worsening of amotivation anxiety and continues to feel stressed with bladder sling ang mesh surgery related complications.The patient will also be seeing a neurologist to help her with pelvic nerve damage relate.On (b)(6) 2021, during her psychotherapy visits, it was mentioned that the patient presents a slight improvement on her cognitive behavior.Boston scientific corporation received additional information on march 23, 2022 as follows: on (b)(6) 2020, the patient reportedly underwent a lysis of hymenal scar and release of eroded vaginal mesh for the treatment of dyspareunia.During the surgery, the hymenal scar and posterior vaginal wall was injected with a 1% lidocaine with epinephrine.A vertical incision was made.Using metzenbaum scissors the posterior hymenal ring and posterior vaginal mucosa was dissected off from the underlying perineal fascia.The underlying band of retracted scar tissue was released.The incision was extending laterally to allow at the introitus, to mobilize the overlying vaginal mucosa.The perineal body was reinforced with 3 figure of eight stitches.Gelfoam was placed between the perineal fascia and the overlying mucosa for hemostasis.The vaginal mucosa was reapproximated in a horizontal fashion using a running locking stitch 3-0 vicryl.The perineum was closed using 3-0 vicryl in a subcuticular fashion.Attention was then placed on the area of mesh erosion near the bladder neck the mesh was gently grasped and an approximate 3mm segment excised.The exposed mesh edges retracted, and no visible mesh was noted.Vaginal packing with premarin cream was inserted.Premarin cream was placed along the suture line.Lastly, the patient was awakened and was taken to the recovery room in stable condition.

Event Description

Boston scientific corporation received additional information on january 14, 2022 as follows: medical and surgical history included mixed urinary incontinence, dyspareunia and perineal pain (noted to have a ridge along the hymenal ring which was painful to the touch; perineal pain unresponsive to massage with lidocaine), obesity, herpes encephalitis, low grade squamous intraepithelial dysplasia, multiple colposcopies, cervical biopsy with loop excision, migraines, panic disorder, episodic mood disorder, generalized anxiety disorder, depression, meningitis, smoking, and cholecystectomy.On (b)(6) 2020, the patient underwent a pubovaginal sling procedure for the treatment of stress incontinence.Cystourethroscopy performed after sling placement revealed submucosal blue mesh without evidence of any injury to the bladder.The foley catheter was reinserted and then the right side of the mesh and anchor was loosened and repositioned.Repeat cystoscopy showed that the mesh was no longer in the bladder submucosa.Post-procedure, the patient was taken to the recovery room in a stable condition.On (b)(6) 2020, the patient went for a follow-up visit.The patient reported 70-80 percent reduction in stress urinary incontinence after the sling implantation.The patient is on vesicare with improved frequency and urgency.The patient reports leaks occasionally with laugh, sneeze and picking up of children.Exam revealed no exposed or palpable mesh and no bleeding from the incision.Slight leakage was noted with coughing and bearing down.On (b)(6), 2020, the patient reportedly underwent an excision of scar along the hymenal ring that was thought to be due to scarring from perineal laceration after her vaginal delivery.On (b)(6) 2020, at her postoperative appointment, the patient was doing well and had no pain.In addition, the patient reported that she would be seen by the urology service on (b)(6) 2020 for urinary incontinence and erosion of mesh.She was wearing pads continuously.During pelvic examination, the patient is noted to have a leakage of urine.The perineum and posterior vagina was noted to have a mild separation of wound.The exposed suture was clipped and the wound remained intact.The mesh was not visible but the edges were palpable.The physician was concerned about the constant pad use and how it was impacting her wound healing.She was advised to keep the area clean and as dry as possible.The patient was advised to resume all regular activities as tolerated.Patient to continue pelvic rest with limited activities, no heavy lifting or strenuous exercise.On (b)(6) 2020, went for a follow-up visit.The patient reports exposed mesh.She had a vaginoplasty surgery 2 weeks ago that removed some exposed mesh but then saw more exposure on a post-op check on (b)(6)2020.The patient still leaks occasionally with laugh, sneeze and picking up of children.Exam revealed the mesh was difficult to see but was palpable.There was no discharge or bleeding.The patient was advised to follow up in 3 weeks.On (b)(6) 2020, the patient underwent an excision of vaginal mesh and cystourethroscopy.The operative report notes the surgeon attempted to release the mesh from its anchors in the pelvic sidewall but was unsuccessful because of the well incorporated portions of mesh in the deeper layers.The mesh was traced back as far laterally on the right side as possible and then excised with sharp scissors.The same was done on the left side.The mesh was removed.The patient tolerated the procedure well and was taken to the recovery room in a stable condition.On (b)(6) 2020, the patient went for a postoperative follow-up visit.During the examination, the vaginal anterior wall was intact.No discoloration or bleeding noted.Cystocele is not present.On (b)(6)2020, the patient presents for follow-up.The patient reports that she is doing well and the incision site feels much better.Her incontinence is still persistent.The patient is frustrated regarding her recovery and outcome from her urologic procedure.Exam showed a well healed incision site, no palpable tenderness along the scar, and sutures intact anteriorly from mesh removal.The patient was interested in alternative options for management of her incontinence, and she was referred to urogynecology.On (b)(6)2021, the patient presented with chronic pelvic pain syndrome, vaginismus, and pelvic floor hypertonia with pudendal nerve involvement (noted in (b)(6) 2020).The patient reported pain at the vagina, bilateral perineum that feels like a "golf ball sensation" and bilateral thighs since 3 weeks post sling procedure; urinary urgency and frequency and sometimes "doesn't make it to the bathroom in time; pain with vaginal penetration; pain that is worse with sitting.Predisposing factors were noted as anxiety/depression; a history of heavy, painful and irregular menses; and status post sling removal (b)(6) 2020 after vaginal wall mesh erosion.The patient states she saw her obgyn who was reportedly concerned about nerve damage.Currently, the patient rates her symptoms 9 of 10 and describes them as stabbing.The plan was pelvic floor physical therapy (pfpt) 1-2x/week or 8-12 weeks for pelvic floor hypertonia.Boston scientific corporation received additional information on february 2, 2022 as follows: on (b)(6) 2020, the patient underwent a psychotherapy.The patient presents a slight worsening of amotivation anxiety and continues to feel stressed with bladder sling ang mesh surgery related complications.The patient will also be seeing a neurologist to help her with pelvic nerve damage relate.On (b)(6) 2021 and (b)(6)2021, during her psychotherapy visits, it was mentioned that the patient presents a slight improvement on her cognitive behavior.Boston scientific corporation received additional information on march 23, 2022 as follows: on (b)(6) 2020, the patient reportedly underwent a lysis of hymenal scar and release of eroded vaginal mesh for the treatment of dyspareunia.During the surgery, the hymenal scar and posterior vaginal wall was injected with a 1% lidocaine with epinephrine.A vertical incision was made.Using metzenbaum scissors the posterior hymenal ring and posterior vaginal mucosa was dissected off from the underlying perineal fascia.The underlying band of retracted scar tissue was released.The incision was extending laterally to allow at the introitus, to mobilize the overlying vaginal mucosa.The perineal body was reinforced with 3 figure of eight stitches.Gelfoam was placed between the perineal fascia and the overlying mucosa for hemostasis.The vaginal mucosa was reapproximated in a horizontal fashion using a running locking stitch 3-0 vicryl.The perineum was closed using 3-0 vicryl in a subcuticular fashion.Attention was then placed on the area of mesh erosion near the bladder neck the mesh was gently grasped and an approximate 3mm segment excised.The exposed mesh edges retracted, and no visible mesh was noted.Vaginal packing with premarin cream was inserted.Premarin cream was placed along the suture line.Lastly, the patient was awakened and was taken to the recovery room in stable condition.Boston scientific corporation received additional information on november 3, 2022 as follows: the patient called the doctor on (b)(6)2020, to inquire whether she had spoken to the urology department since she could see her bladder mesh.The patient and the doctor also talked about the patient's intraoperative results.The patient is reportedly doing well and not complaining, per the report.She has been applying premarin cream every night, and her pain is well managed.A follow-up consultation with the patient was scheduled for (b)(6) 2020.Additionally, the patient came in for a gynecologic exam on (b)(6) 2020, at the clinic.According to reports, the patient receives depo-provera for contraception and cycle control and is considering tubal sterilization (history of menorrhagia).The patient would like to talk about her alternatives.Notably, the patient is currently receiving treatment from urogynecology for her persistent pelvic pain and incontinence.She had a mid-urethral sling, which has already been removed.Her issues were thought to be due to her mid-urethral sling.

Manufacturer Narrative

Block h2: additional information.Blocks b5 (narrative) and b7 (other relevant history) has been updated based on the additional information received on november 3, 2022.Block b3 date of event: date of event was approximated to (b)(6)2020, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The physicians are: dr.(b)(6).(b)(6).(b)(6).Dr.(b)(6).(b)(6) urology.(b)(6).Dr.(b)(6).(b)(6) group.(b)(6).Block h6: patient code e2326, e1405, e2006, e2330, e0123, e020201, e2340, e020202, e1715 captures the reportable events of inflammation, dyspareunia, erosion, pain, nerve damage, anxiety, wound dehiscence, depression and scar tissue.Impact code f18, f1903, f2303 captures the reported events of rehabilitation, mesh removal, medication required.

Manufacturer Narrative

Lock h2: additional information block b5 and h6 (patient and impact codes) has been updated based on the additional information received on july 19, 2023.Block b3 date of event: date of event was approximated to (b)(6) 2020, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The physicians are: dr.(b)(6) block h6: the following imdrf patient codes capture the reportable events of: e2006 - has been used to capture the reported event of erosion.E2330 - has been used to capture the reported event of pain.E2006 - has been used to capture the reported event of.E1405 - has been used to capture the reported event of dyspareunia.E020201 - has been used to capture the reported event of anxiety.E1715 - has been used to capture the reported event of scar tissue.E0123 - has been used to capture the reported event of nerve damage.E2340 - has been used to capture the reported event of dehiscence.E020202 - has been used to capture the reported event of depression.E1413 - has been used to capture the reported event of patient can not enjoy clitoral stimulation secondary to pain.The following imdrf impact codes capture the reportable events of: f1905 - has been used to capture the reported event of required medication.F18 - has been used to capture the reported event of device revision.F1903 - has been used to capture the reported event of rehabilitation.F2303 - has been used to capture the reported event of device removal.

Event Description

It was reported to boston scientific corporation that a solyx sis 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 corporation received additional information on january 14, 2022, as follows: medical and surgical history included mixed urinary incontinence, dyspareunia and perineal pain (noted to have a ridge along the hymenal ring which was painful to the touch; perineal pain unresponsive to massage with lidocaine), obesity, herpes encephalitis, low-grade squamous intraepithelial dysplasia, multiple colposcopies, cervical biopsy with loop excision, migraines, panic disorder, episodic mood disorder, generalized anxiety disorder, depression, meningitis, smoking, and cholecystectomy.On (b)(6) 2020, the patient underwent a pubovaginal sling procedure for the treatment of stress incontinence.Cystourethroscopy performed after sling placement revealed submucosal blue mesh without evidence of any injury to the bladder.The foley catheter was reinserted, and then the right side of the mesh and anchor was loosened and repositioned.Repeat cystoscopy showed that the mesh was no longer in the bladder submucosa.Post-procedure, the patient was taken to the recovery room in stable condition.On (b)(6) 2020, the patient went for a follow-up visit.The patient reported a 70-80 percent reduction in stress urinary incontinence after the sling implantation.The patient is on vesicare with improved frequency and urgency.The patient reports leaks occasionally with laughing, sneezing, and picking up of children.Exam revealed no exposed or palpable mesh and no bleeding from the incision.Slight leakage was noted with coughing and bearing down.On (b)(6) 2020, the patient reportedly underwent an excision of scar along the hymenal ring that was thought to be due to scarring from perineal laceration after her vaginal delivery.On september 1, 2020, at her postoperative appointment, the patient was doing well and had no pain.In addition, the patient reported that she would be seen by the urology service on september 8, 2020 for urinary incontinence and erosion of mesh.She was wearing pads continuously.During pelvic examination, the patient is noted to have a leakage of urine.The perineum and posterior vagina was noted to have a mild separation of wound.The exposed suture was clipped and the wound remained intact.The mesh was not visible but the edges were palpable.The physician was concerned about the constant pad use and how it was impacting her wound healing.She was advised to keep the area clean and as dry as possible.The patient was advised to resume all regular activities as tolerated.Patient to continue pelvic rest with limited activities, no heavy lifting or strenuous exercise.On (b)(6) 2020, went for a follow-up visit.The patient reports exposed mesh.She had a vaginoplasty surgery 2 weeks ago that removed some exposed mesh but then saw more exposure on a post-op check on september 1, 2020.The patient still leaks occasionally with laugh, sneeze and picking up of children.Exam revealed the mesh was difficult to see but was palpable.There was no discharge or bleeding.The patient was advised to follow up in 3 weeks.On (b)(6) 2020, the patient underwent an excision of vaginal mesh and cystourethroscopy.The operative report notes the surgeon attempted to release the mesh from its anchors in the pelvic sidewall but was unsuccessful because of the well incorporated portions of mesh in the deeper layers.The mesh was traced back as far laterally on the right side as possible and then excised with sharp scissors.The same was done on the left side.The mesh was removed.The patient tolerated the procedure well and was taken to the recovery room in a stable condition.On (b)(6) 2020, the patient went for a postoperative follow-up visit.During the examination, the vaginal anterior wall was intact.No discoloration or bleeding noted.Cystocele is not present.On (b)(6) 2020, the patient presents for follow-up.The patient reports that she is doing well and the incision site feels much better.Her incontinence is still persistent.The patient is frustrated regarding her recovery and outcome from her urologic procedure.Exam showed a well healed incision site, no palpable tenderness along the scar, and sutures intact anteriorly from mesh removal.The patient was interested in alternative options for management of her incontinence, and she was referred to urogynecology.On (b)(6) 2021, the patient presented with chronic pelvic pain syndrome, vaginismus, and pelvic floor hypertonia with pudendal nerve involvement (noted in july 2020).The patient reported pain at the vagina, bilateral perineum that feels like a "golf ball sensation" and bilateral thighs since 3 weeks post sling procedure; urinary urgency and frequency and sometimes "doesn't make it to the bathroom in time; pain with vaginal penetration; pain that is worse with sitting.Predisposing factors were noted as anxiety/depression; a history of heavy, painful and irregular menses; and status post sling removal september 2020 after vaginal wall mesh erosion.The patient states she saw her obgyn who was reportedly concerned about nerve damage.Currently, the patient rates her symptoms 9 of 10 and describes them as stabbing.The plan was pelvic floor physical therapy (pfpt) 1-2x/week or 8-12 weeks for pelvic floor hypertonia.Boston scientific corporation received additional information on february 2, 2022 as follows: on (b)(6) 2020, the patient underwent a psychotherapy.The patient presents a slight worsening of amotivation anxiety and continues to feel stressed with bladder sling ang mesh surgery related complications.The patient will also be seeing a neurologist to help her with pelvic nerve damage relate.On (b)(6) 2021, during her psychotherapy visits, it was mentioned that the patient presents a slight improvement on her cognitive behavior.Boston scientific corporation received additional information on march 23, 2022 as follows: on (b)(6) 2020, the patient reportedly underwent lysis of hymenal scar and release of eroded vaginal mesh for the treatment of dyspareunia.During the surgery, the hymenal scar and posterior vaginal wall was injected with a 1% lidocaine with epinephrine.A vertical incision was made.Using metzenbaum scissors the posterior hymenal ring and posterior vaginal mucosa was dissected off from the underlying perineal fascia.The underlying band of retracted scar tissue was released.The incision was extending laterally to allow at the introitus, to mobilize the overlying vaginal mucosa.The perineal body was reinforced with 3 figure of eight stitches.Gelfoam was placed between the perineal fascia and the overlying mucosa for hemostasis.The vaginal mucosa was reapproximated in a horizontal fashion using a running locking stitch 3-0 vicryl.The perineum was closed using 3-0 vicryl in a subcuticular fashion.Attention was then placed on the area of mesh erosion near the bladder neck the mesh was gently grasped and an approximate 3mm segment excised.The exposed mesh edges retracted, and no visible mesh was noted.Vaginal packing with premarin cream was inserted.Premarin cream was placed along the suture line.Lastly, the patient was awakened and was taken to the recovery room in stable condition.Boston scientific corporation received additional information on november 3, 2022, as follows: the patient called the doctor on (b)(6) 2020, to inquire whether she had spoken to the urology department since she could see her bladder mesh.The patient and the doctor also talked about the patient's intraoperative results.The patient is reportedly doing well and not complaining, per the report.She has been applying premarin cream every night, and her pain is well managed.A follow-up consultation with the patient was scheduled for (b)(6) 2020.Additionally, the patient came to the clinic for a gynecologic exam on (b)(6) 2020.According to reports, the patient receives depo-provera for contraception and cycle control and is considering tubal sterilization (history of menorrhagia).The patient would like to talk about her alternatives.Notably, the patient is currently receiving treatment from urogynecology for her persistent pelvic pain and incontinence.She had a mid-urethral sling, which had already been removed.Her issues were thought to be due to her mid-urethral sling.Boston scientific corporation received additional information on july 19, 2023: due to pain or possible pudendal neuralgia, the patient had a virtual telehealth visit on (b)(6) 2022.The patient complained of pain in her clitoris and labial area.She also notes pain in the groin and medial thigh bilaterally.Pain is increased with prolonged standing and walking.She also gets pain with the adduction of her legs.The pain sometimes has a burning quality versus an electrical shock quality.She also notes vaginal and perineal pain with sitting or any contact with the area.The patient cannot wear tight clothing.She denies any rectal pain.Bowel movement is normal.The patient cannot have sex secondary to deep dyspareunia.The patient can not enjoy clitoral stimulation secondary to pain.She cannot achieve an orgasm.The patient notes that arousal itself is painful.The patient has had two mesh revisions since.In (b)(6) 2020, she had a very small portion of the central part of the sling removed with a perineal revision.In (b)(6) 2020, she had 1.2 cm of the vaginal component removed.The anchors are still in place.The patient has not noted any significant pain relief since those procedures.According to the physician, they have reviewed the pathophysiology of the pain and its association with these devices.The patient's pain is most likely mediated by the remainder of the mesh and the anchors.Part of this depends on how far through the obturator membrane the device was inserted.The physician also briefly reviewed the possible utility of removing the remainder of the device.They also discussed the need for a physical examination to confirm that the retained mesh with anchors is the cause of her pain.The patient could then decide on possible surgery for removal.On (b)(6) 2022, the patient presented for a physical examination to discuss treatment options for her pelvic pain complaints.According to the physician, the patient has been playing with pain consistent with both obturator and pudendal neuralgia since.The patient had a mesh erosion.In (b)(6) 2020, she had a very small segment of the mesh removed (5mm) with a perineal revision.In september 2020, she had a 1.2 cm segment removed.The entire amount of mesh removed appears to be just below 2 cm.The patient's pain complaints are unchanged.Her urinary incontinence is worse.According to the physician, they have reviewed treatment options.One option would be to proceed with vaginal exploration to look for any residual mesh in that compartment coupled with bilateral groin dissection to remove the anchors.Also, the patient will probably under increased risk for symptoms when the anchors are advanced too far through the obturator membrane.This also would make it very difficult, if not impossible, to remove transvaginally.They also have reviewed that removing the anchors is technically challenging, and there is certainly the possibility of being unable to remove them.They also reviewed surgical risks such as bleeding, and wound infection.Moreover, an alternative treatment that could be considered is a stimulator.This has the advantage of being much less invasive.It also has the possibility of treating both pudendal and obturator neuralgia.The following report details the results of the patient's physical examination, as documented by the physician: general: overweight middle-aged female appears quite uncomfortable.External genitalia: diffuse allodynia involving the clitoris labia and introitus, positive skin rolling sensitivity, positive point tenderness along the inferior pubic rami.Bimanual: the uterus is normal size and non-tender, no masses palpated; the levator plate is quite tender to palpation, including the obturator internus muscle; mesh could not be readily palpated.

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Brand Name

SOLYX SIS SYSTEM

Type of Device

MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

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

12158918

MDR Text Key

261263824

Report Number

3005099803-2021-03363

Device Sequence Number

Product Code

PAH

UDI-Device Identifier

08714729961901

UDI-Public

08714729961901

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K081275

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer,Company Representative

Reporter Occupation

Non-Healthcare Professional

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

06/19/2022

Device Model Number

M0068507010

Device Lot Number

0023985789

Was Device Available for Evaluation?

Initial Date Manufacturer Received

06/16/2021

Initial Date FDA Received

07/13/2021

Supplement Dates Manufacturer Received

01/14/2022
02/02/2022
02/25/2022
03/23/2022
11/03/2022
07/19/2023

Supplement Dates FDA Received

02/11/2022
03/01/2022
03/25/2022
04/20/2022
11/22/2022
08/14/2023

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

06/20/2019

Is the Device Single Use?

Yes

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Other; Required Intervention;

Patient Age

62 YR

Patient Sex

Female

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

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