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

Device Problem Positioning Problem (3009)

Patient Problems Erosion (1750); Hematoma (1884); Pain (1994); Rash (2033); Scar Tissue (2060); Urinary Retention (2119); Depression (2361); Numbness (2415); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of on (b)(6) 2014 was chosen as a best estimate based on the information that the mesh implanted in 2014.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Initial reporter name and address: this event was reported by the patient's legal representation.The implanting facility was: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during a procedure performed in 2014.On (b)(6) 2019, the patient went to a clinic to address her chronic female pelvic pain, dyspareunia, a foreign body in the vagina, and difficulty voiding.The patient reportedly experienced a significant hematoma that extended from the groin area up to the suprapubic area right after the mesh was implanted, and it took some time for it to lessen and disappear.In addition, she has experienced vaginal pain since the surgery, particularly during set penetration and sexual intercourse.She also occasionally experiences pain in her groin, primarily on the right, which might be mistaken for a period.The physician discussed the next steps in her management during the visit, but the doctor could see during the examination that the patient had a quite a diffuse, intense rash that tracked from the suprapubic area into the groin area and actually mimicked the neckline.To help with this, the physician has prescribed trimovate cream, which she can apply up to three times each day and possibly for a very long period.Reportedly, the physician has seen such rashes before in patients who have had mesh and wonders if this is an intense allergic reaction to the mesh itself.Moreover, during the examination of the vagina, the physician could feel the mesh edges on the two sides of the anterior fornices.The physician could palpate not only the mesh edge but also flick it around on the left side.The physician hoped that by treating the skin with cream, things would improve.The physician also mentioned that the mesh is clearly too tight and that the edges are quite raw on the vaginal skin.On (b)(6) 2020, the patient had a consultation primarily due to abdominal pain.Reportedly, the patient's uterus, endometrium, and ovaries appeared to be normal.The bladder appeared normal as well, and the postresidual volume was 15 ml.A mesh was noted extending bilaterally from the suburethral region laterally to the obturator region, which was suggestive of a transobturator mesh.The mesh appeared intact; however, it appeared to be situated low.There was no evidence of mesh erosion in the urethra, vagina, or bladder.However, scarring was noted in the anterior vaginal wall.On palpation, the pelvic organs were mobile and nontender.Douglas' pouch was free of adhesions.However, the patient was extremely tender at the site of the mesh vaginally.On (b)(6) 2020, the patient had a consultation via telephone with a complaint of a foreign body in the vagina.According to the physician, the mesh was placed too tight, and as a consequence, she had voiding dysfunction and chronic groin pain.The physician mentioned that a surgery was planned to have the patient's mesh removed, since it was quite clear that the mesh was the cause of her symptoms.Furthermore, the mesh edges were palpable beneath the vaginal skin when the patient first visited the clinic.According to the physician's letter, by on (b)(6) 2021, the patient's pain had become intermittent, allowing her to use pacing strategies.The patient can walk for 2 to 3 miles before the groin pain arrives.The patient also described her pain as sharp and sudden, similar to a pinch or an elastic band around her urethra, vagina, and bladder, and that it does not appear to be caused by any activity.The patient reportedly used crutches due to a torn meniscus in her left knee, although she was also treated locally.The patient also lacked sensation, which prevented her from pushing.Additionally, 2-3 times a week, typically when her bowels have not been opened, she must do intermittent self-catheterization.The patient's bowel movements have normalized with a careful diet.The patient reportedly lost her business and house as a result of her incapacity to work after the mesh implantation.The patient also said she was trying to resume horse riding but that she found 1 hour to be too much.Pacing was brought up during the consultation, and the doctor recommended the patient to take it slow and not push herself too hard.By doing this, many people are able to resume activities they had previously written off as being out of their range.The patient was also aware that removing the mesh might not completely alleviate her pain, but she was 90% certain that she wanted the mesh removed since she was concerned that things might grow worse if it were.She was understandably anxious about undergoing more surgery, though, and she was eager to discuss the advantages and disadvantages of doing so with the surgical team.According to the patient's progress reports from on (b)(6) 2021, the patient was readmitted in on (b)(6) 2015 for what she thought was a procedure to remove the mesh, but she was instead given steroidal injections.These were ineffective, and she still suffers from chronic pain.She describes the pain as constant but punctuated by stinging electric shocks, similar to flare-ups that occur suddenly.The patient developed a painful rash, which was treated with a cream.This has had a significant impact on the quality of her life.She used to be a very active person who enjoyed being outdoors and hiking.The patient is saddened by her inability to accomplish these activities and can only walk up to a mile before experiencing acute pain.The patient explained how the mesh affected her intimacy and intercourse with her husband.She was particularly upset because doctors did not believe her about the pelvic pain she was suffering during intercourse, implying that she did not want to have sex with her husband.This caused problems in her marriage, and she was relieved to be able to refute this when it became evident that the mesh was the source of her pain.Furthermore, the patient is reluctant to utilize any stronger medication than what she can obtain over the counter.As a retired nurse, she is well aware of the limitations of pain medication and is attempting to manage it as well as possible by using the least quantity of medicine.As part of the treatment protocol, the physician informed the patient that she will be reviewed by the mesh pain team.The patient did not receive any psychological support during a very distressing and difficult period in her life.She had previously seen a psychologist after the tragic death of her daughter and an attempted suicide in 1982.She has felt very low at times over the last six years as a result of the complications of the mesh insertion, but she is not suicidal.Meanwhile, the patient is aware that removing the mesh may aggravate her condition.She is, however, terrified of having to live with the mesh for an extended period of time.She is concerned about it eroding into her urethra and causing other complications.She is concerned about having more surgery because her previous experiences have not been positive, but she would prefer to proceed with the removal.

Event Description

It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during a procedure performed in 2014.On (b)(6) 2019, the patient went to a clinic to address her chronic female pelvic pain, dyspareunia, a foreign body in the vagina, and difficulty voiding.The patient reportedly experienced a significant hematoma that extended from the groin area up to the suprapubic area right after the mesh was implanted, and it took some time for it to lessen and disappear.In addition, she has experienced vaginal pain since the surgery, particularly during set penetration and sexual intercourse.She also occasionally experiences pain in her groin, primarily on the right, which might be mistaken for a period.The physician discussed the next steps in her management during the visit, but the doctor could see during the examination that the patient had a quite a diffuse, intense rash that tracked from the suprapubic area into the groin area and actually mimicked the neckline.To help with this, the physician has prescribed trimovate cream, which she can apply up to three times each day and possibly for a very long period.Reportedly, the physician has seen such rashes before in patients who have had mesh and wonders if this is an intense allergic reaction to the mesh itself.Moreover, during the examination of the vagina, the physician could feel the mesh edges on the two sides of the anterior fornices.The physician could palpate not only the mesh edge but also flick it around on the left side.The physician hoped that by treating the skin with cream, things would improve.The physician also mentioned that the mesh is clearly too tight and that the edges are quite raw on the vaginal skin.On (b)(6) 2020, the patient had a consultation primarily due to abdominal pain.Reportedly, the patient's uterus, endometrium, and ovaries appeared to be normal.The bladder appeared normal as well, and the postresidual volume was 15 ml.A mesh was noted extending bilaterally from the suburethral region laterally to the obturator region, which was suggestive of a transobturator mesh.The mesh appeared intact; however, it appeared to be situated low.There was no evidence of mesh erosion in the urethra, vagina, or bladder.However, scarring was noted in the anterior vaginal wall.On palpation, the pelvic organs were mobile and nontender.Douglas' pouch was free of adhesions.However, the patient was extremely tender at the site of the mesh vaginally.On (b)(6) 2020, the patient had a consultation via telephone with a complaint of a foreign body in the vagina.According to the physician, the mesh was placed too tight, and as a consequence, she had voiding dysfunction and chronic groin pain.The physician mentioned that a surgery was planned to have the patient's mesh removed, since it was quite clear that the mesh was the cause of her symptoms.Furthermore, the mesh edges were palpable beneath the vaginal skin when the patient first visited the clinic.According to the physician's letter, by (b)(6) 2021, the patient's pain had become intermittent, allowing her to use pacing strategies.The patient can walk for 2 to 3 miles before the groin pain arrives.The patient also described her pain as sharp and sudden, similar to a pinch or an elastic band around her urethra, vagina, and bladder, and that it does not appear to be caused by any activity.The patient reportedly used crutches due to a torn meniscus in her left knee, although she was also treated locally.The patient also lacked sensation, which prevented her from pushing.Additionally, 2-3 times a week, typically when her bowels have not been opened, she must do intermittent self-catheterization.The patient's bowel movements have normalized with a careful diet.The patient reportedly lost her business and house as a result of her incapacity to work after the mesh implantation.The patient also said she was trying to resume horse riding but that she found 1 hour to be too much.Pacing was brought up during the consultation, and the doctor recommended the patient to take it slow and not push herself too hard.By doing this, many people are able to resume activities they had previously written off as being out of their range.The patient was also aware that removing the mesh might not completely alleviate her pain, but she was 90% certain that she wanted the mesh removed since she was concerned that things might grow worse if it were.She was understandably anxious about undergoing more surgery, though, and she was eager to discuss the advantages and disadvantages of doing so with the surgical team.According to the patient's progress reports from (b)(6) 2021, the patient was readmitted in (b)(6) 2015 for what she thought was a procedure to remove the mesh, but she was instead given steroidal injections.These were ineffective, and she still suffers from chronic pain.She describes the pain as constant but punctuated by stinging electric shocks, similar to flare-ups that occur suddenly.The patient developed a painful rash, which was treated with a cream.This has had a significant impact on the quality of her life.She used to be a very active person who enjoyed being outdoors and hiking.The patient is saddened by her inability to accomplish these activities and can only walk up to a mile before experiencing acute pain.The patient explained how the mesh affected her intimacy and intercourse with her husband.She was particularly upset because doctors did not believe her about the pelvic pain she was suffering during intercourse, implying that she did not want to have sex with her husband.This caused problems in her marriage, and she was relieved to be able to refute this when it became evident that the mesh was the source of her pain.Furthermore, the patient is reluctant to utilize any stronger medication than what she can obtain over the counter.As a retired nurse, she is well aware of the limitations of pain medication and is attempting to manage it as well as possible by using the least quantity of medicine.As part of the treatment protocol, the physician informed the patient that she will be reviewed by the mesh pain team.The patient did not receive any psychological support during a very distressing and difficult period in her life.She had previously seen a psychologist after the tragic death of her daughter and an attempted suicide in 1982.She has felt very low at times over the last six years as a result of the complications of the mesh insertion, but she is not suicidal.Meanwhile, the patient is aware that removing the mesh may aggravate her condition.She is, however, terrified of having to live with the mesh for an extended period of time.She is concerned about it eroding into her urethra and causing other complications.She is concerned about having more surgery because her previous experiences have not been positive, but she would prefer to proceed with the removal.

Manufacturer Narrative

Block h2: correction blocks h6 (patient codes e1309 and e020202) and (impact code f1202) has been added based on the correction received on december 1, 2022.Blocks a1 and a2 has been removed as per per eu gdpr (general data protection regulation).Block a1: as per eu gdpr (general data protection regulation), only the patient's weight, gender, and age can be reported in any regulatory report.Thus, the patient's initials and date of birth will not be documented.Block b3 date of event: the exact event onset date is unknown.The provided event date of january 1, 2014 was chosen as a best estimate based on the information that the mesh implanted in 2014.Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting facility was: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2330 - pain e1309 - urinary retention e2006 - erosion e1405 - dyspareunia e1715 - scar tissue e020202 - depression the following imdrf impact codes capture the reportable events of: f2309 - required medication f1202 - patient lost her business and house as a result of her incapacity to work after the mesh implantation f12 - patient sought for a legal recourse for the injuries related to the device.

• Brand Name: OBTRYX SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15909297
• MDR Text Key: 304782875
• Report Number: 3005099803-2022-06978
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female