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BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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| Model Number M0068502110 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Adhesion(s) (1695); Erosion (1750); Fatigue (1849); Micturition Urgency (1871); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Itching Sensation (1943); Memory Loss/Impairment (1958); Muscle Weakness (1967); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Visual Disturbances (2140); Burning Sensation (2146); Urinary Frequency (2275); Anxiety (2328); Depression (2361); Prolapse (2475); Sleep Dysfunction (2517); Cognitive Changes (2551); Weight Changes (2607); Constipation (3274); Movement Disorder (4412); Urethral Stenosis/Stricture (4501); Dyspareunia (4505); Sexual Dysfunction (4510); Urinary Incontinence (4572); Insufficient Information (4580)
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| Event Date 07/31/2012 |
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Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that an advantage fit system was used during a procedure performed on (b)(6) 2012.As reported by the patient's attorney, the patient experienced an unknown injury.
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2012, procedure date, as no event date was reported.(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 identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system was used during a procedure performed on (b)(6) 2012.As reported by the patient's attorney, the patient experienced an unknown injury.***additional information received on (b)(6), 2022*** on (b)(6), 2022, the patient was seen and examined for moderate bladder symptoms which began nine years ago.She stated the symptoms were chronic and are uncontrolled.In 2012, the patient had a placement of advantage fit for stress incontinence.There were no revisions or removals.The patient reported that in the beginning of 2013, she had itching all over her body.Dermatology was unable to diagnose any cause for this.She was sexually active and reported dyspareunia.She had vaginal dryness and a decreased libido.She reported a burning sensation after intercourse that can last for several days.She also frequently had uti following intercourse.Patient reported decreased sensitivity at her clitoris.Denied vaginal discharge or bleeding.Patient saw a urogyn last year, who did a vaginal exam and did not find exposure, however the patient's partner has been cut by something in her vagina during intercourse.She reported an aching pain in the vagina, which was a dull ache that extended to her rectum.She reported recurrent utis since sling placement and estimated 3-4 yearly culture confirmed infections.Last year the patient had kidney infections.The patient reported urinary leakage with urgency, leakage when laughing, coughing or sneezing, urinary frequency, feelings of incomplete bladder emptying, and nocturia.Patient reported severe constipation and that she went for weeks without having a bowel movement.Patient reported in the past two years experiencing left groin pain, worse with exercise.She also had lower back pain.She reported "brain fog" that has been present in the past year, and difficulty retaining information.As part of the review of systems, the patient reported experiencing fatigue and weight gain, vision changes, constipation, gait disturbance, memory impairment, anxiety, depression, insomnia, back pain, joint pain, muscle weakness, and easy bruising and bleeding.The patient also experienced incomplete emptying, nocturia prolapsed uterus and urge incontinence.Exam revealed a palpable painful urethral cord, the perineum was attenuated, there was vaginal pain from the right cord, and pain at the right obturator internus.In the physician's assessment, the patient needed pre-operative urodynamic evaluation and follow up with dnp.Surgery has been offered for removal of the previous advantage fit sling mesh, urethral iysis and anterior colporrhaphy as well as removal of the mesh from the abdominal wall and the abdominal paravaginal space.The patient was extensively counseled that even with the removal of her mesh, she may continue to have pain and there was no guarantee that she will be pain free or even experience an improvement from pain.She was also counseled that she would not undergo reconstruction with this surgery as this would be only to remove the mesh.The patient has been counseled on the risks and benefits of surgery, alternate approaches and procedures as well as complications which included but were not limited to bleeding, infection as well as failure to achieve the desired physiologic result.The patient stated that she understood, had no questions, was given an opportunity to ask questions and wished to proceed with surgery.On (b)(6), 2022, the patient underwent an advantage sling removal, urethral lysis, anterior colporrhaphy, removal of abdominal mesh.Preoperative diagnosis includes vaginal pain, pelvic pain, and pain with coitus.Post operative diagnosis includes vaginal pain, pelvic pain, pain with coitus and urinary stricture.During the procedure, the patient was taken to the operating room and placed on the operating room table in a comfortable supine position.Following an adequate level of general endotracheal anesthesia, the patient was repositioned in a modified dorsal lithotomy position, prepped and draped in the usual manner for vaginal surgery.The physician noted that this was very difficult surgery due to the right vaginal section of the sling being covered by paper thin tissue, the left sling arm being in the urethral wall and the obturator muscle as well as the right arm scarred to the pubic bone.Foley catheter was inserted and noted to be draining clear yellow urine.Two allis clamps were placed on the anterior vaginal wall and an incision was made directly into the anterior vaginal wall.The previous advantage sling was identified and located on the patient's right covered with by paper thin tissue.The tissue was taken off as best as possible but the tissue over the sling was not able to be removed.The mesh was incised in the midline and dissected as far as lateral as possible.A urethral lysis was performed with sharp dissection to further free the urethra and scar tissue.The dissection was carried to the contralateral side.The sling arm on the right was freed from the underlying sub-urethral tissues and followed to the pubic bone.The sling on the right was freed from the underlying sub-urethral tissues and the bone and the end was held with a clamp.The sling arm on the left was freed from the urethral wall tissues and followed to the obturator muscle and noted to be much deeper in the muscles.The sling mesh end was held with a clamp.Attention was directed to the abdominal component.A transverse skin incision was made on the left and on the right and these incisions was sharply taken down to the level of the fascia.The mesh was identified in the fascia and the fascia was incised around the mesh and the mesh dissected free exposing the rectus muscles.The retropubic space was opened bilaterally to visualize the mesh, progressive dissection mobilized the left sling arm from the obturator muscle and completely freed the left sling arm.The mesh was dissected free, and bleeding was noted within the obturator muscle and bladder wall and that was controlled with gentle cautery.The vaginal clamp was released, and the entire sling left arm was handed off the operative field.The right sling arm was previously identified and also freed from the fascia and rectus muscles.The mesh was followed and was adherent on the pubic bone that was freed with sharp dissection.The vaginal clamp was released, and the entire sling arm was handed off the operative field.Copious irrigation was performed.Floseal and gelfoam was placed at the dissection areas.The rectus muscles were approximated in the midline with interrupted sutures and the fascia was closed.Subcutaneous tissues were reapproximated with interrupted sutures.Skin edges were reapproximated with staples.Attention was directed to the vaginal incision.Hemostasis was excellent.The urethral wall was repaired with interrupted sutures.The anterior vaginal wall was closed with running suture.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.The specimen was received for gross examination in a single container labeled with the patient's name and "advantage mesh." the pieces of mesh have a small amount of adherent pink fibrous tissue.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to (b)(6), 2012, procedure date, as no event date was reported.Block h6: patient code e2401 captures the reportable event of unknown injury.Impact code f12 has been used in the light of this patient seeking legal recourse for an unspecified personal injury related to the device.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 problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: blocks a2, b2, b5, b7, d6b, h6, and h10 have been updated based on the additional information received on (b)(6), 2022.Block h6: patient code e2330 captures the reportable events of "moderate uncontrolled chronic groin, lower back, vaginal, rectal, and pelvic pain." patient code e1705 captures the reportable event of "a burning sensation after intercourse that can last for several days." patient code e2006 captures the reportable event of "the patient's partner has been cut by something in her vagina during intercourse." patient code e1405 captures the reportable event of "dyspareunia." patient code e1906 captures the reportable event of "the patient had kidney infections." patient code e1307 captures the reportable event of "urinary stricture." patient code e1309 captures the reportable event of feelings of incomplete bladder emptying." patient code e1310 captures the reportable events of "reported recurrent utis" patient code e1708 captures the reportable event of "she had itching allover her body." patient code e0838 captures the reportable event of "visual disturbances." patient code e2101captures the reportable event of "adhesions." patient code e1715 captures the reportable event of "scar tissue." patient code e0107 captures the reportable event of "brain fog." impact code f1903: device explantation captures the reportable event of "advantage sling removal." impact code f1901: additional surgery captures the reportable events of "urethral lysis," and "anterior colporrhaphy." impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: blocks b5, h6 and h10 have been corrected based on the medical review received on december 7, 2022.Block h6: patient code e020201 captures the reportable event of anxiety.Patient code e0120 captures the reportable event of memory loss.Patient code e0122 captures the reportable event of postural gait disturbances.Patient code 2006 captures the reportable event of erosion.Patient code 1621 captures the reportable event of muscle weakness.Patient code e0130 captures the reportable event of insomnia.Patient code e0505 captures the reportable event of easy bruising.Patient code e0506 captures the reportable event of easy bleeding.Patient code e020202 captures the reportable event of depression.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to july 31, 2012, procedure date, as no event date was reported.Block h6: patient code e2401 captures the reportable event of unknown injury.Impact code f12 has been used in the light of this patient seeking legal recourse for an unspecified personal injury related to the device.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 problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: blocks a2, b2, b5, b7, d6b, h6, and h10 have been updated based on the additional information received on november 3, 2022.Block h6: patient code e2330 captures the reportable events of "moderate uncontrolled chronic groin, lower back, vaginal, rectal, and pelvic pain." patient code e1705 captures the reportable event of "a burning sensation after intercourse that can last for several days." patient code e2006 captures the reportable event of "the patient's partner has been cut by something in her vagina during intercourse." patient code e1405 captures the reportable event of "dyspareunia." patient code e1906 captures the reportable event of "the patient had kidney infections." patient code e1307 captures the reportable event of "urinary stricture." patient code e1309 captures the reportable event of feelings of incomplete bladder emptying." patient code e1310 captures the reportable events of "reported recurrent utis" patient code e1708 captures the reportable event of "she had itching allover her body." patient code e0838 captures the reportable event of "visual disturbances." patient code e2101captures the reportable event of "adhesions." patient code e1715 captures the reportable event of "scar tissue." patient code e0107 captures the reportable event of "brain fog." impact code f1903: device explantation captures the reportable event of "advantage sling removal." impact code f1901: additional surgery captures the reportable events of "urethral lysis," and "anterior colporrhaphy." impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system was used during a procedure performed on (b)(6) 2012.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on november 3, 2022.On (b)(6) 2022, the patient was seen and examined for moderate bladder symptoms which began nine years ago.She stated the symptoms were chronic and are uncontrolled.In 2012, the patient had a placement of advantage fit for stress incontinence.There were no revisions or removals.The patient reported that in the beginning of 2013, she had itching all over her body.Dermatology was unable to diagnose any cause for this.She was sexually active and reported dyspareunia.She had vaginal dryness and a decreased libido.She reported a burning sensation after intercourse that can last for several days.She also frequently had uti following intercourse.Patient reported decreased sensitivity at her clitoris.Denied vaginal discharge or bleeding.Patient saw a urogyn last year, who did a vaginal exam and did not find exposure, however the patient's partner has been cut by something in her vagina during intercourse.She reported an aching pain in the vagina, which was a dull ache that extended to her rectum.She reported recurrent utis since sling placement and estimated 3-4 yearly culture confirmed infections.Last year the patient had kidney infections.The patient reported urinary leakage with urgency, leakage when laughing, coughing or sneezing, urinary frequency, feelings of incomplete bladder emptying, and nocturia.Patient reported severe constipation and that she went for weeks without having a bowel movement.Patient reported in the past two years experiencing left groin pain, worse with exercise.She also had lower back pain.She reported "brain fog" that has been present in the past year, and difficulty retaining information.Upon examination, the patient was experiencing fatigue and weight gain.The patient also had vision changes.The patient was constipated.The patient also experienced incomplete emptying, nocturia prolapsed uterus and urge incontinence.In the physician's assessment, the patient needed pre-operative urodynamic evaluation and follow up with dnp.Surgery has been offered for removal of the previous advantage fit sling mesh, urethral iysis and anterior colporrhaphy as well as removal of the mesh from the abdominal wall and the abdominal paravaginal space.The patient was extensively counseled that even with the removal of her mesh, she may continue to have pain and there was no guarantee that she will be pain free or even experience an improvement from pain.She was also counseled that she would not undergo reconstruction with this surgery as this would be only to remove the mesh.The patient has been counseled on the risks and benefits of surgery, alternate approaches and procedures as well as complications which included but were not limited to bleeding, infection as well as failure to achieve the desired physiologic result.The patient stated that she understood, had no questions, was given an opportunity to ask questions and wished to proceed with surgery.On (b)(6) 2022, the patient underwent an advantage sling removal, urethral lysis, anterior colporrhaphy, removal of abdominal mesh.Preoperative diagnosis includes vaginal pain, pelvic pain, and pain with coitus.Post operative diagnosis includes vaginal pain, pelvic pain, pain with coitus and urinary stricture.During the procedure, the patient was taken to the operating room and placed on the operating room table in a comfortable supine position.Following an adequate level of general endotracheal anesthesia, the patient was repositioned in a modified dorsal lithotomy position, prepped and draped in the usual manner for vaginal surgery.The physician noted that this was very difficult surgery due to the right vaginal section of the sling being covered by paper thin tissue, the left sling arm being in the urethral wall and the obturator muscle as well as the right arm scarred to the pubic bone.Foley catheter was inserted and noted to be draining clear yellow urine.Two allis clamps were placed on the anterior vaginal wall and an incision was made directly into the anterior vaginal wall.The previous advantage sling was identified and located on the patient's right covered with by paper thin tissue.The tissue was taken off as best as possible but the tissue over the sling was not able to be removed.The mesh was incised in the midline and dissected as far as lateral as possible.A urethral lysis was performed with sharp dissection to further free the urethra and scar tissue.The dissection was carried to the contralateral side.The sling arm on the right was freed from the underlying sub-urethral tissues and followed to the pubic bone.The sling on the right was freed from the underlying sub-urethral tissues and the bone and the end was held with a clamp.The sling arm on the left was freed from the urethral wall tissues and followed to the obturator muscle and noted to be much deeper in the muscles.The sling mesh end was held with a clamp.Attention was directed to the abdominal component.A transverse skin incision was made on the left and on the right and these incisions was sharply taken down to the level of the fascia.The mesh was identified in the fascia and the fascia was incised around the mesh and the mesh dissected free exposing the rectus muscles.The retropubic space was opened bilaterally to visualize the mesh, progressive dissection mobilized the left sling arm from the obturator muscle and completely freed the left sling arm.The mesh was dissected free, and bleeding was noted within the obturator muscle and bladder wall and that was controlled with gentle cautery.The vaginal clamp was released, and the entire sling left arm was handed off the operative field.The right sling arm was previously identified and also freed from the fascia and rectus muscles.The mesh was followed and was adherent on the pubic bone that was freed with sharp dissection.The vaginal clamp was released, and the entire sling arm was handed off the operative field.Copious irrigation was performed.Floseal and gelfoam was placed at the dissection areas.The rectus muscles were approximated in the midline with interrupted sutures and the fascia was closed.Subcutaneous tissues were reapproximated with interrupted sutures.Skin edges were reapproximated with staples.Attention was directed to the vaginal incision.Hemostasis was excellent.The urethral wall was repaired with interrupted sutures.The anterior vaginal wall was closed with running suture.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.The specimen was received for gross examination in a single container labeled with the patient's name and "advantage mesh." the pieces of mesh have a small amount of adherent pink fibrous tissue.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to july 31, 2012, procedure date, as no event date was reported.Block h6: patient code e2401 captures the reportable event of unknown injury.Impact code f12 has been used in the light of this patient seeking legal recourse for an unspecified personal injury related to the device.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 problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h6: patient code e2330 captures the reportable events of "moderate uncontrolled chronic groin, lower back, vaginal, rectal, and pelvic pain." patient code e1705 captures the reportable event of "a burning sensation after intercourse that can last for several days." patient code e2006 captures the reportable event of "the patient's partner has been cut by something in her vagina during intercourse." patient code e1405 captures the reportable event of "dyspareunia." patient code e1906 captures the reportable event of "the patient had kidney infections." patient code e1307 captures the reportable event of "urinary stricture." patient code e1309 captures the reportable event of feelings of incomplete bladder emptying." patient code e1310 captures the reportable events of "reported recurrent utis" patient code e1708 captures the reportable event of "she had itching allover her body." patient code e0838 captures the reportable event of "visual disturbances." patient code e2101captures the reportable event of "adhesions." patient code e1715 captures the reportable event of "scar tissue." patient code e0107 captures the reportable event of "brain fog." impact code f1903: device explantation captures the reportable event of "advantage sling removal." impact code f1901: additional surgery captures the reportable events of "urethral lysis," and "anterior colporrhaphy." impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h6: patient code e020201 captures the reportable event of anxiety.Patient code e0120 captures the reportable event of memory loss.Patient code e0122 captures the reportable event of postural gait disturbances.Patient code 2006 captures the reportable event of erosion.Patient code 1621 captures the reportable event of muscle weakness.Patient code e0130 captures the reportable event of insomnia.Patient code e0505 captures the reportable event of easy bruising.Patient code e0506 captures the reportable event of easy bleeding.Patient code e020202 captures the reportable event of depression.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: (b)(6).Revision surgery performed by: (b)(6).
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Event Description
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It was reported to boston scientific corporation that an advantage fit system was used during a procedure performed on (b)(6) 2012.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on november 3, 2022: on (b)(6) 2022, the patient was seen and examined for moderate bladder symptoms which began nine years ago.She stated the symptoms were chronic and are uncontrolled.In 2012, the patient had a placement of advantage fit for stress incontinence.There were no revisions or removals.The patient reported that in the beginning of 2013, she had itching all over her body.Dermatology was unable to diagnose any cause for this.She was sexually active and reported dyspareunia.She had vaginal dryness and a decreased libido.She reported a burning sensation after intercourse that can last for several days.She also frequently had uti following intercourse.Patient reported decreased sensitivity at her clitoris.Denied vaginal discharge or bleeding.Patient saw a urogyn last year, who did a vaginal exam and did not find exposure, however the patient's partner has been cut by something in her vagina during intercourse.She reported an aching pain in the vagina, which was a dull ache that extended to her rectum.She reported recurrent utis since sling placement and estimated 3-4 yearly culture confirmed infections.Last year the patient had kidney infections.The patient reported urinary leakage with urgency, leakage when laughing, coughing or sneezing, urinary frequency, feelings of incomplete bladder emptying, and nocturia.Patient reported severe constipation and that she went for weeks without having a bowel movement.Patient reported in the past two years experiencing left groin pain, worse with exercise.She also had lower back pain.She reported "brain fog" that has been present in the past year, and difficulty retaining information.As part of the review of systems, the patient reported experiencing fatigue and weight gain, vision changes, constipation, gait disturbance, memory impairment, anxiety, depression, insomnia, back pain, joint pain, muscle weakness, and easy bruising and bleeding.The patient also experienced incomplete emptying, nocturia prolapsed uterus and urge incontinence.Exam revealed a palpable painful urethral cord, the perineum was attenuated, there was vaginal pain from the right cord, and pain at the right obturator internus.In the physician's assessment, the patient needed pre-operative urodynamic evaluation and follow up with dnp.Surgery has been offered for removal of the previous advantage fit sling mesh, urethral iysis and anterior colporrhaphy as well as removal of the mesh from the abdominal wall and the abdominal paravaginal space.The patient was extensively counseled that even with the removal of her mesh, she may continue to have pain and there was no guarantee that she will be pain free or even experience an improvement from pain.She was also counseled that she would not undergo reconstruction with this surgery as this would be only to remove the mesh.The patient has been counseled on the risks and benefits of surgery, alternate approaches and procedures as well as complications which included but were not limited to bleeding, infection as well as failure to achieve the desired physiologic result.The patient stated that she understood, had no questions, was given an opportunity to ask questions and wished to proceed with surgery.On (b)(6) 2022, the patient underwent an advantage sling removal, urethral lysis, anterior colporrhaphy, removal of abdominal mesh.Preoperative diagnosis includes vaginal pain, pelvic pain, and pain with coitus.Post operative diagnosis includes vaginal pain, pelvic pain, pain with coitus and urinary stricture.During the procedure, the patient was taken to the operating room and placed on the operating room table in a comfortable supine position.Following an adequate level of general endotracheal anesthesia, the patient was repositioned in a modified dorsal lithotomy position, prepped and draped in the usual manner for vaginal surgery.The physician noted that this was very difficult surgery due to the right vaginal section of the sling being covered by paper thin tissue, the left sling arm being in the urethral wall and the obturator muscle as well as the right arm scarred to the pubic bone.Foley catheter was inserted and noted to be draining clear yellow urine.Two allis clamps were placed on the anterior vaginal wall and an incision was made directly into the anterior vaginal wall.The previous advantage sling was identified and located on the patient's right covered with by paper thin tissue.The tissue was taken off as best as possible but the tissue over the sling was not able to be removed.The mesh was incised in the midline and dissected as far as lateral as possible.A urethral lysis was performed with sharp dissection to further free the urethra and scar tissue.The dissection was carried to the contralateral side.The sling arm on the right was freed from the underlying sub-urethral tissues and followed to the pubic bone.The sling on the right was freed from the underlying sub-urethral tissues and the bone and the end was held with a clamp.The sling arm on the left was freed from the urethral wall tissues and followed to the obturator muscle and noted to be much deeper in the muscles.The sling mesh end was held with a clamp.Attention was directed to the abdominal component.A transverse skin incision was made on the left and on the right and these incisions was sharply taken down to the level of the fascia.The mesh was identified in the fascia and the fascia was incised around the mesh and the mesh dissected free exposing the rectus muscles.The retropubic space was opened bilaterally to visualize the mesh, progressive dissection mobilized the left sling arm from the obturator muscle and completely freed the left sling arm.The mesh was dissected free, and bleeding was noted within the obturator muscle and bladder wall and that was controlled with gentle cautery.The vaginal clamp was released, and the entire sling left arm was handed off the operative field.The right sling arm was previously identified and also freed from the fascia and rectus muscles.The mesh was followed and was adherent on the pubic bone that was freed with sharp dissection.The vaginal clamp was released, and the entire sling arm was handed off the operative field.Copious irrigation was performed.Floseal and gelfoam was placed at the dissection areas.The rectus muscles were approximated in the midline with interrupted sutures and the fascia was closed.Subcutaneous tissues were reapproximated with interrupted sutures.Skin edges were reapproximated with staples.Attention was directed to the vaginal incision.Hemostasis was excellent.The urethral wall was repaired with interrupted sutures.The anterior vaginal wall was closed with running suture.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.The specimen was received for gross examination in a single container labeled with the patient's name and "advantage mesh." the pieces of mesh have a small amount of adherent pink fibrous tissue.Additional information received on december 20, 2022: the implant procedure performed on (b)(6) 2012 was sling implant (advantage fit) and cystoscopy procedure to treat a patient with stress urinary incontinence.The patient complained of abdominal pressure with incomplete bladder emptying after voiding.Operative findings include no trauma to the bladder, no lesions in the bladder at the time of cystoscopy.Hemostasis was observed throughout the procedure, and the patient returned to the supine position.She was awoken and brought to the recovery room in stable condition.There were no complications reported at the conclusion of the implant procedure.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system was used during a procedure performed on (b)(6) 2012.As reported by the patient's attorney, the patient experienced an unknown injury.***additional information received on november 3, 2022*** on (b)(6) 2022, the patient was seen and examined for moderate bladder symptoms which began nine years ago.She stated the symptoms were chronic and are uncontrolled.In 2012, the patient had a placement of advantage fit for stress incontinence.There were no revisions or removals.The patient reported that in the beginning of 2013, she had itching all over her body.Dermatology was unable to diagnose any cause for this.She was sexually active and reported dyspareunia.She had vaginal dryness and a decreased libido.She reported a burning sensation after intercourse that can last for several days.She also frequently had uti following intercourse.Patient reported decreased sensitivity at her clitoris.Denied vaginal discharge or bleeding.Patient saw a urogyn last year, who did a vaginal exam and did not find exposure, however the patient's partner has been cut by something in her vagina during intercourse.She reported an aching pain in the vagina, which was a dull ache that extended to her rectum.She reported recurrent utis since sling placement and estimated 3-4 yearly culture confirmed infections.Last year the patient had kidney infections.The patient reported urinary leakage with urgency, leakage when laughing, coughing or sneezing, urinary frequency, feelings of incomplete bladder emptying, and nocturia.Patient reported severe constipation and that she went for weeks without having a bowel movement.Patient reported in the past two years experiencing left groin pain, worse with exercise.She also had lower back pain.She reported "brain fog" that has been present in the past year, and difficulty retaining information.As part of the review of systems, the patient reported experiencing fatigue and weight gain,vision changes, constipation, gait disturbance, memory impairment, anxiety, depression, insomnia, back pain, joint pain, muscle weakness, and easy bruising and bleeding.The patient also experienced incomplete emptying, nocturia prolapsed uterus and urge incontinence.Exam revealed a palpable painful urethral cord, the perineum was attenuated, there was vaginal pain from the right cord, and pain at the right obturator internus.In the physician's assessment, the patient needed pre-operative urodynamic evaluation and follow up with dnp.Surgery has been offered for removal of the previous advantage fit sling mesh, urethral iysis and anterior colporrhaphy as well as removal of the mesh from the abdominal wall and the abdominal paravaginal space.The patient was extensively counseled that even with the removal of her mesh, she may continue to have pain and there was no guarantee that she will be pain free or even experience an improvement from pain.She was also counseled that she would not undergo reconstruction with this surgery as this would be only to remove the mesh.The patient has been counseled on the risks and benefits of surgery, alternate approaches and procedures as well as complications which included but were not limited to bleeding, infection as well as failure to achieve the desired physiologic result.The patient stated that she understood, had no questions, was given an opportunity to ask questions and wished to proceed with surgery.On (b)(6) 2022 , the patient underwent an advantage sling removal, urethral lysis, anterior colporrhaphy, removal of abdominal mesh.Preoperative diagnosis includes vaginal pain, pelvic pain, and pain with coitus.Post operative diagnosis includes vaginal pain, pelvic pain, pain with coitus and urinary stricture.According to the patient, the symptoms began 9 years ago and generally lasts 9 years.The symptoms are reported as being moderate.The symptoms occur daily.The location is bladder.She states the symptoms are chronic and are uncontrolled.During the procedure, the patient was taken to the operating room and placed on the operating room table in a comfortable supine position.Following an adequate level of general endotracheal anesthesia, the patient was repositioned in a modified dorsal lithotomy position, prepped and draped in the usual manner for vaginal surgery.The physician noted that this was very difficult surgery due to the right vaginal section of the sling being covered by paper thin tissue, the left sling arm being in the urethral wall and the obturator muscle as well as the right arm scarred to the pubic bone.Foley catheter was inserted and noted to be draining clear yellow urine.Two allis clamps were placed on the anterior vaginal wall and an incision was made directly into the anterior vaginal wall.The previous advantage sling was identified and located on the patient's right covered with by paper thin tissue.The tissue was taken off as best as possible but the tissue over the sling was not able to be removed.The mesh was incised in the midline and dissected as far as lateral as possible.A urethral lysis was performed with sharp dissection to further free the urethra and scar tissue.The dissection was carried to the contralateral side.The sling arm on the right was freed from the underlying sub-urethral tissues and followed to the pubic bone.The sling on the right was freed from the underlying sub-urethral tissues and the bone and the end was held with a clamp.The sling arm on the left was freed from the urethral wall tissues and followed to the obturator muscle and noted to be much deeper in the muscles.The sling mesh end was held with a clamp.Attention was directed to the abdominal component.A transverse skin incision was made on the left and on the right and these incisions was sharply taken down to the level of the fascia.The mesh was identified in the fascia and the fascia was incised around the mesh and the mesh dissected free exposing the rectus muscles.The retropubic space was opened bilaterally to visualize the mesh, progressive dissection mobilized the left sling arm from the obturator muscle and completely freed the left sling arm.The mesh was dissected free, and bleeding was noted within the obturator muscle and bladder wall and that was controlled with gentle cautery.The vaginal clamp was released, and the entire sling left arm was handed off the operative field.The right sling arm was previously identified and also freed from the fascia and rectus muscles.The mesh was followed and was adherent on the pubic bone that was freed with sharp dissection.The vaginal clamp was released, and the entire sling arm was handed off the operative field.Copious irrigation was performed.Floseal and gelfoam was placed at the dissection areas.The rectus muscles were approximated in the midline with interrupted sutures and the fascia was closed.Subcutaneous tissues were reapproximated with interrupted sutures.Skin edges were reapproximated with staples.Attention was directed to the vaginal incision.Hemostasis was excellent.The urethral wall was repaired with interrupted sutures.The anterior vaginal wall was closed with running suture.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.The specimen was received for gross examination in a single container labeled with the patient's name and advantage mesh.The pieces of mesh have a small amount of adherent pink fibrous tissue.***additional information received on december 20, 2022*** the implant procedure performed on (b)(6) 2012 was sling implant (advantage fit) and cystoscopy procedure to treat a patient with stress urinary incontinence.The patient complained of abdominal pressure with incomplete bladder emptying after voiding.Operative findings include no trauma to the bladder, no lesions in the bladder at the time of cystoscopy.Hemostasis was observed throughout the procedure, and the patient returned to the supine position.She was awoken and brought to the recovery room in stable condition.There were no complications reported at the conclusion of the implant procedure.***additional information received on june 26, 2023*** the patient visited the center for sexual medicine and menopause on (b)(6) 2021, seeking treatment for low libido, orgasm issues, dyspareunia, and urge incontinence.She has a history of frequent urinary tract infections and kidney infections.Although her menstrual cycle is monthly, the flow has become lighter.The patient reports experiencing uncomfortable vaginal symptoms such as dryness and pain during sexual activity, which are bothersome.She also reports that her partner can feel the mesh during intercourse.The patient has been experiencing consistent pelvic pressure and pain since her bladder sling procedure.The patient reports that the symptoms began 5 years ago, after the sling was implanted and her blood pressure medication was changed.During the vulvovaginal examination, it was noted that the mesh was slightly palpable.There was no local erosion, but a firm region measuring 5-6mm and located 2cm from the midline of the introitus.To address vulvodynia, the patient was prescribed gabapentin 6% and baclofen 2%, to be applied thrice daily.To treat her pelvic floor dysfunction, hyposexual desire disorder, low iibido, and orgasm disorder, the patient was further advised to undergo pelvic floor therapy and sex therapy.On february 8, 2021, the patient complained of urge incontinence and painful intercourse, and she also feels fullness in the vagina and believes that her prolapse has returned.The patient also reports that her partner has felt a hardness in her vagina and has received an abrasion that is scabbing over; she also felt a bulge when she checked her vagina.The following are the patient's visit diagnoses: urge incontinence of urine pelvic floor dysfunction incomplete emptying of the bladder (primary) high-tone pelvic floor dysfunction urinary frequency urinary urgency chronic female pelvic pain dyspareunia due to medical conditions in female uterovaginal prolapse the physician and the patient talked about treatment possibilities.They discussed each option's efficacy, side effects, complications, urinary tract infections, and self-catheterization rates.Given her prior sling, they will begin with a cystoscopy to rule out any reversible causes of her problems.High tone pelvic floor dysfunction and dyspareunia.After thoroughly discussing her pelvic pain symptoms and pelvic floor dysfunction, it was determined that the cause was likely myofascial.As a result, they decided to start a course of pelvic floor physical therapy and schedule a follow-up assessment in 3 months.Hispareunia with her history of a prior sling and abrasion, and scab on her partner's penis, the physician explained that they had to determine if the mesh was exposed in the vagina, as this can sometimes cause these symptoms.They discussed that if this is the case, the mesh would need to be excised via a simple procedure and that her stress incontinence could return.Prolapse per the physician, this symptom, while bothersome, is lower on her problem list.Depending on her exam findings, they could observe, do physical therapy, pessary, or surgery.On (b)(6) 2021, the patient arrived at the clinic to discuss sexual problems.Sex, according to the patient, is awkward and unpleasant.Her sexual satisfaction began to deteriorate in 2016.Her partner is occasionally scratched by the sling.He once showed her a scratch on his penis.She has to use lubricants since her vagina is dry.If she doesn't use the lubricants, she will have a burning sensation during intercourse.Her libido has also decreased as a result of this problem.Furthermore, the patient's ultrasound revealed a 4.02mm endometrium, indicating adenomyosis.A post-ovulatory cyst measuring 2x1.37 cm has been discovered in the right ovary.The left ovary is within normal limits.There is free fluid in the posterior cul de sac, which measures 2x0.8cm.There is a posterior ss fibroid that measures 2.6x2cm.On (b)(6) 2021, the patient returned for a check-up following a mid-urethral sling for urgency incontinence, urinary frequency syndrome, and dyspareunia.She also has certain symptoms that are consistent with mesh exposure.High-tone pelvic floor dysfunction, an overactive bladder, and dyspareunia were all observed in the patient.Her cystoscopy, according to the physician, was normal, with no evidence of pathology or sling issues.They discussed her findings, and given her young age and high-tone pelvic floor dysfunction, they concluded that she would first address her pelvic floor issues.They could afterward manage any residual urge, frequency, or urgency urinary incontinence.They also had a long discussion about her pain symptoms, pelvic floor dysfunction, and the likely myofascial etiology of her symptoms.Furthermore, they agreed that she would begin a course of pelvic floor physical therapy and return for further assessment in 3 months.The patient arrived at the emergency department alert and oriented on (b)(6) 2022.She complains of pain in her lower abdomen, pelvis, rectum, and low back.Previous medical history of bladder mesh removal: approximately two weeks.She was given oxycodone for post-operative pain, but it provided no relief.She also complains of pain when her bladder is full.There is no burning or blood in the urine.
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Manufacturer Narrative
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Block h2: correction: corrections to blocks b5 (event description) and h10 (additional narrative) has been made.Block b3 date of event: date of event was approximated to july 31, 2012, 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 physician is: dr.(b)(6).Revision surgery performed by: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable event of: patient code e2330 captures the reportable events of "moderate uncontrolled chronic groin, lower back, vaginal, rectal, and pelvic pain." patient code e1705 captures the reportable event of "a burning sensation after intercourse that can last for several days." patient code e2006 captures the reportable event of "the patient's partner has been cut by something in her vagina during intercourse." patient code e1405 captures the reportable event of "dyspareunia." patient code e1906 captures the reportable event of "the patient had kidney infections." patient code e1307 captures the reportable event of "urinary stricture." patient code e1309 captures the reportable event of feelings of incomplete bladder emptying." patient code e1310 captures the reportable events of "reported recurrent utis" patient code e1708 captures the reportable event of "she had itching allover her body." patient code e0838 captures the reportable event of "visual disturbances." patient code e2101captures the reportable event of "adhesions." patient code e1715 captures the reportable event of "scar tissue." patient code e0107 captures the reportable event of "brain fog." patient code e2401 captures the reportable event of "high-tone pelvic floor dysfunction." the following imdrf impact code capture the reportable event of: impact code f1903: device explantation captures the reportable event of "advantage sling removal." impact code f1901: additional surgery captures the reportable events of "urethral lysis," and "anterior colporrhaphy." impact code f2303: medication required - used to capture the reported events of patient was given pain gabapentin and baclofen as well as oxycodone.Impact code f18: rehabilitation - used to capture the reported event of patient had to undergo pelvic floor physical therapy.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system was used during a procedure performed on (b)(6) 2012.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on november 3, 2022.On (b)(6) 2022, the patient was seen and examined for moderate bladder symptoms which began nine years ago.She stated the symptoms were chronic and are uncontrolled.In 2012, the patient had a placement of advantage fit for stress incontinence.There were no revisions or removals.The patient reported that in the beginning of 2013, she had itching all over her body.Dermatology was unable to diagnose any cause for this.She was sexually active and reported dyspareunia.She had vaginal dryness and a decreased libido.She reported a burning sensation after intercourse that can last for several days.She also frequently had uti following intercourse.Patient reported decreased sensitivity at her clitoris.Denied vaginal discharge or bleeding.Patient saw a urogyn last year, who did a vaginal exam and did not find exposure, however the patient's partner has been cut by something in her vagina during intercourse.She reported an aching pain in the vagina, which was a dull ache that extended to her rectum.She reported recurrent utis since sling placement and estimated 3-4 yearly culture confirmed infections.Last year the patient had kidney infections.The patient reported urinary leakage with urgency, leakage when laughing, coughing or sneezing, urinary frequency, feelings of incomplete bladder emptying, and nocturia.Patient reported severe constipation and that she went for weeks without having a bowel movement.Patient reported in the past two years experiencing left groin pain, worse with exercise.She also had lower back pain.She reported "brain fog" that has been present in the past year, and difficulty retaining information.As part of the review of systems, the patient reported experiencing fatigue and weight gain,vision changes, constipation, gait disturbance, memory impairment, anxiety, depression, insomnia, back pain, joint pain, muscle weakness, and easy bruising and bleeding.The patient also experienced incomplete emptying, nocturia prolapsed uterus and urge incontinence.Exam revealed a palpable painful urethral cord, the perineum was attenuated, there was vaginal pain from the right cord, and pain at the right obturator internus.In the physician's assessment, the patient needed pre-operative urodynamic evaluation and follow up with dnp.Surgery has been offered for removal of the previous advantage fit sling mesh, urethral iysis and anterior colporrhaphy as well as removal of the mesh from the abdominal wall and the abdominal paravaginal space.The patient was extensively counseled that even with the removal of her mesh, she may continue to have pain and there was no guarantee that she will be pain free or even experience an improvement from pain.She was also counseled that she would not undergo reconstruction with this surgery as this would be only to remove the mesh.The patient has been counseled on the risks and benefits of surgery, alternate approaches and procedures as well as complications which included but were not limited to bleeding, infection as well as failure to achieve the desired physiologic result.The patient stated that she understood, had no questions, was given an opportunity to ask questions and wished to proceed with surgery.On (b)(6) 2022, the patient underwent an advantage sling removal, urethral lysis, anterior colporrhaphy, removal of abdominal mesh.Preoperative diagnosis includes vaginal pain, pelvic pain, and pain with coitus.Post operative diagnosis includes vaginal pain, pelvic pain, pain with coitus and urinary stricture.During the procedure, the patient was taken to the operating room and placed on the operating room table in a comfortable supine position.Following an adequate level of general endotracheal anesthesia, the patient was repositioned in a modified dorsal lithotomy position, prepped and draped in the usual manner for vaginal surgery.The physician noted that this was very difficult surgery due to the right vaginal section of the sling being covered by paper thin tissue, the left sling arm being in the urethral wall and the obturator muscle as well as the right arm scarred to the pubic bone.Foley catheter was inserted and noted to be draining clear yellow urine.Two allis clamps were placed on the anterior vaginal wall and an incision was made directly into the anterior vaginal wall.The previous advantage sling was identified and located on the patient's right covered with by paper thin tissue.The tissue was taken off as best as possible but the tissue over the sling was not able to be removed.The mesh was incised in the midline and dissected as far as lateral as possible.A urethral lysis was performed with sharp dissection to further free the urethra and scar tissue.The dissection was carried to the contralateral side.The sling arm on the right was freed from the underlying sub-urethral tissues and followed to the pubic bone.The sling on the right was freed from the underlying sub-urethral tissues and the bone and the end was held with a clamp.The sling arm on the left was freed from the urethral wall tissues and followed to the obturator muscle and noted to be much deeper in the muscles.The sling mesh end was held with a clamp.Attention was directed to the abdominal component.A transverse skin incision was made on the left and on the right and these incisions was sharply taken down to the level of the fascia.The mesh was identified in the fascia and the fascia was incised around the mesh and the mesh dissected free exposing the rectus muscles.The retropubic space was opened bilaterally to visualize the mesh, progressive dissection mobilized the left sling arm from the obturator muscle and completely freed the left sling arm.The mesh was dissected free, and bleeding was noted within the obturator muscle and bladder wall and that was controlled with gentle cautery.The vaginal clamp was released, and the entire sling left arm was handed off the operative field.The right sling arm was previously identified and also freed from the fascia and rectus muscles.The mesh was followed and was adherent on the pubic bone that was freed with sharp dissection.The vaginal clamp was released, and the entire sling arm was handed off the operative field.Copious irrigation was performed.Floseal and gelfoam was placed at the dissection areas.The rectus muscles were approximated in the midline with interrupted sutures and the fascia was closed.Subcutaneous tissues were reapproximated with interrupted sutures.Skin edges were reapproximated with staples.Attention was directed to the vaginal incision.Hemostasis was excellent.The urethral wall was repaired with interrupted sutures.The anterior vaginal wall was closed with running suture.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.The specimen was received for gross examination in a single container labeled with the patient's name and advantage mesh.The pieces of mesh have a small amount of adherent pink fibrous tissue.Additional information received on december 20, 2022.The implant procedure performed on (b)(6) 2012 was sling implant (advantage fit) and cystoscopy procedure to treat a patient with stress urinary incontinence.The patient complained of abdominal pressure with incomplete bladder emptying after voiding.Operative findings include no trauma to the bladder, no lesions in the bladder at the time of cystoscopy.Hemostasis was observed throughout the procedure, and the patient returned to the supine position.She was awoken and brought to the recovery room in stable condition.There were no complications reported at the conclusion of the implant procedure.Additional information received on june 26, 2023.The patient visited the (b)(6) on (b)(6) 2021, seeking treatment for low libido, orgasm issues, dyspareunia, and urge incontinence.She has a history of frequent urinary tract infections and kidney infections.Although her menstrual cycle is monthly, the flow has become lighter.The patient reports experiencing uncomfortable vaginal symptoms such as dryness and pain during sexual activity, which are bothersome.The patient has been experiencing consistent pelvic pressure and pain since her bladder sling procedure.During the vulvovaginal examination, it was noted that the mesh was slightly palpable.There was no local erosion, but a firm region measuring 5-6mm and located 2cm from the midline of the introitus.To address vulvodynia, the patient was prescribed gabapentin 6% and baclofen 2%, to be applied thrice daily.To treat her pelvic floor dysfunction, hyposexual desire disorder, low iibido, and orgasm disorder, the patient was further advised to undergo pelvic floor therapy and sex therapy.On (b)(6) 2021, the patient complained of urge incontinence and painful intercourse, and she also feels fullness in the vagina and believes that her prolapse has returned.The patient also reports that her partner has felt a hardness in her vagina and has received an abrasion that is scabbing over; she also felt a bulge when she checked her vagina.The following are the patient's visit diagnoses: urge incontinence of urine; pelvic floor dysfunction; incomplete emptying of the bladder (primary); high-tone pelvic floor dysfunction; urinary frequency ; urinary urgency; chronic female pelvic pain; dyspareunia due to medical conditions in female ; uterovaginal prolapse.The physician and the patient talked about treatment possibilities.They discussed each option's efficacy, side effects, complications, urinary tract infections, and self-catheterization rates.Given her prior sling, they will begin with a cystoscopy to rule out any reversible causes of her problems.High tone pelvic floor dysfunction and dyspareunia.After thoroughly discussing her pelvic pain symptoms and pelvic floor dysfunction, it was determined that the cause was likely myofascial.As a result, they decided to start a course of pelvic floor physical therapy and schedule a follow-up assessment in 3 months.Hispareunia.With her history of a prior sling and abrasion, and scab on her partner's penis, the physician explained that we had to determine if the mesh was exposed in the vagina, as this can sometimes cause these symptoms.They discussed that if this is the case, the mesh would need to be excised via a simple procedure and that her stress incontinence could return.Prolapse this symptom, while bothersome, is lower on her problem list.Depending on her exam findings, they could observe, do physical therapy, pessary, or surgery.On (b)(6) 2021, the patient arrived at the clinic to discuss sexual problems.Sex, according to the patient, is awkward and unpleasant.Her sexual satisfaction began to deteriorate in 2016.Her partner is occasionally scratched by the sling.He once showed her a scratch on his penis.She has to use lubricants since her vagina is dry.If she doesn't use the lubricants, she will have a burning sensation during intercourse.Her libido has also decreased as a result of this problem.Furthermore, the patient's ultrasound revealed a 4.02mm endometrium, indicating adenomyosis.A post-ovulatory cyst measuring 2x1.37 cm has been discovered in the right ovary.The left ovary is within normal limits.There is free fluid in the posterior cul de sac, which measures 2x0.8cm.There is a posterior ss fibroid that measures 2.6x2cm.On (b)(6) 2021, the patient returned for a check-up following a mid-urethral sling for urgency incontinence, urinary frequency syndrome, and dyspareunia.She also has certain symptoms that are consistent with mesh exposure.High-tone pelvic floor dysfunction, an overactive bladder, and dyspareunia were all observed in the patient.Her cystoscopy, according to the physician, was normal, with no evidence of pathology or sling issues.They discussed her findings and given her young age and high-tone pelvic floor dysfunction, they concluded that she would first address her pelvic floor issues.They could afterward manage any residual urge, frequency, or urgency urinary incontinence.They also had a long discussion about her pain symptoms, pelvic floor dysfunction, and the likely myofascial etiology of her symptoms.Furthermore, they agreed that she would begin a course of pelvic floor physical therapy and return for further assessment in 3 months.The patient arrived at the clinic alert and oriented on (b)(6) 2022.She complains of pain in her lower abdomen, pelvis, rectum, and low back.Previous medical history of bladder mesh removal: approximately two weeks.She was given oxycodone for post-operative pain, but it provided no relief.She also complains of pain when her bladder is full.There is no burning or blood in the urine.
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