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Clinical investment 

Boston Scientific is committed to supporting evidence-based medicine through sponsoring and funding pelvic health research worldwide.

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The difference is in the data

Boston Scientific invests in research across pelvic health, including stress urinary incontinence, pelvic organ prolapse, and overactive bladder.

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$32M+

invested in FDA-mandated post-market 522 studies and associated publications for pelvic floor devices since 2012

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30

years of physician-driven, customer-centric innovation

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3,500+

patients treated with our pelvic floor repair products in clinical studies around the world

ARTISAN-SNM clinical study: Two-year outcomes

An international, multicenter prospective study evaluated the safety and effectiveness of the Axonics SNM as an aid in the treatment of symptoms of urinary urgency incontinence (UUI) in 129 study participants. Here are the key findings at 2 years.

Patient satisfaction 

Axonics SNM provided sustained reductions in urinary symptoms and delivered high rates of patient satisfaction at 2 years (n=121).

  • 94% of patients were satisfied with Axonics SNM treatment
  • 91% of patients rated the recharging experience as “easy”
  • 93% of patients had a reduction in UUI symptoms by 50% or more 

Quality of life

On average, patients had a 36-point improvement in quality of life, more than 3 times the bar for clinically meaningful improvement. Additionally, patients on average reported clinically meaningful improvements in concern, coping, sleep, and social interactions.

Urinary incontinence safety considerations 

Treatment with the Axonics SNM System was well-tolerated with no serious device-related adverse events reported. 

  • The rate of lead migration was less than 1%
  • The rate of high impedance (suspected lead fracture) was less than 2% 
  • Less than 2% of patients reported implant site pain

Study at a glance

94%

of patients were satisfied with Axonics SNM treatment

91%

of patients rated the recharging experience as “easy”

93%

of patients had ≥50% reduction in UUI symptoms

Less than

1%

rate of lead migration

Less than

2%

rate of high impedance (suspected lead fracture)

Less than

2%

of patients reported implant site pain

Conclusion

At 2 years, participants treated with Axonics SNM demonstrated sustained safety and efficacy as well as high levels of satisfaction with therapy and recharging.

Read the full study

Pezzella A, McCrery R, Lane F, et al. Two-year outcomes of ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system. Neurourol Urodyn. 2021;40:714–721. 

Important safety information

Axonics Sacral Neuromodulation indications, safety, and warnings

Seven-year efficacy and safety outcomes of Bulkamid for the treatment of stress urinary incontinence

An Institutional Review Board-approved single-center retrospective study analyzed 388 female patients with SUI or stress-predominant MUI who had undergone injection with Bulkamid and had completed 7 years of follow up. The primary endpoint was patient satisfaction measured on a four-point scale as cured, improved, unchanged, or worse.

A total of 1,200 patients were treated with Bulkamid and of these, 32.3% had completed 7 years of follow-up.  

  • 67.1% of women reported symptom improvement 
  • 32.2% of patients required a second (“top-up”) injection, most commonly within the first year 
  • Pad usage was reduced by ~50%, and VAS QoL scores improved by ~4.3 points, both considered clinically relevant 
  • 11.1% reported no change 
  • 2.3% reported worsening of incontinence  

Postoperative complications were transient. Most common adverse events (denoted by >10%) included prolonged bladder emptying time (15.3%), frequent urination (9.6%), and nocturia (8.6%).  

Study at a glance

67.1%

of women reported symptom improvement at 7 years following Bulkamid injection

57.1%

reduction in pad usage, and VAS QoL scores improved by ~4.3 points, both considered clinically relevant 

32.2%

of patients required a second (“top-up”) injection, most commonly within the first year

81%

of patients did not undergo a procedure other than Bulkamid treatment over the course of the 7-year study

Conclusion

Bulkamid is designed to effectively treat women suffering from SUI, with clinical support up to 7 years. 

Read the full study

Brosche T, Kuhn A, Lobodasch K, Sokol ER. Seven-year efficacy and safety outcomes of Bulkamid for the treatment of stress urinary incontinence. Neurourol Urodyn. 2021;40:502–508.

Important safety information

Bulkamid indications, safety, and warnings

Sacrospinous ligament fixation using an anchor versus suture-capturing device: A prospective cohort study

This prospective cohort study evaluated rates of persistent gluteal and posterior thigh pain, procedural efficacy, and postoperative complications at 1 year after sacrospinous ligament fixation, using either an anchor-based or suture-capturing device. 

  • Symptom scores were evaluated via Pelvic Floor Distress Inventory — PFDI 20 and Pelvic Floor Impact Questionnaire (PFIQ-7)
  • Pain was evaluated using the Numerical Rating Scale 
  • Composite surgical failure was defined as prolapse beyond the hymen or C-point greater than one half down the vagina, vaginal bulge symptoms, or a need for prolapse retreatment via surgery or pessary management 

Forty-three (21 anchors, 22 sutures) of the original 47 patients (91%) returned for follow-up. The mean follow-up time was 15.4 months, age was 69 years old, body mass index was 30, and preoperative Pelvic Organ Prolapse Quantification stage was 2.7. 

No patients reported significant increase in pain at sacrospinous fixation site above baseline, and there was no significant difference in posterior thigh or gluteal pain on the side of fixation compared with baseline in the anchor-based or suture-capture groups (−0.2 ± 0.9 and −0.5 ± 1.6, respectively, P = 0.719). 

Two patients, both in the anchor group, demonstrated surgical failure due to bulge symptoms (P = 0.233). The devices similarly improved Pelvic Floor Distress Inventory 20 (−71.0 ± 45.5 vs −66.3 ± 64.4, P = 0.652) and Pelvic Floor Impact Questionnaire 7 (−40.6 ± 62.4 vs −26.4 ± 65.7, P = 0.768) scores. 

Study at a glance

   

0

patients reported significant increase in pain

   

0

patients reported a significant difference in posterior thigh or gluteal pain

Only

2

patients, both in the anchor-based group, demonstrated surgical failure due to bulge symptoms (P=0.233)

Conclusion

Persistent gluteal or posterior thigh pain and surgical failure is uncommon 12 months after sacrospinous fixation and was not associated with the type of fixation device.

Read the full study

McKenzie CM, Crafton CL, Plair A, Matthews CA. Sacrospinous ligament fixation using an anchor versus suture-capturing device: a prospective cohort study. Female Pelvic Med Reconstr Surg. 2022;28:131–135.

Important safety information

Capio Slim indications, safety, and warnings

Solyx 522 post-market study: 36-month data

The Solyx Single Incision Sling System 522 post-market clinical study is a prospective, parallel cohort, non-inferiority study to assess the safety and effectiveness of a single-incision sling. This study evaluated the Solyx Single Incision Sling (SIS) system as compared to the Obtryx™ II Transobturator Mid-Urethral Sling (TMUS) system. 

The Solyx System met all primary and secondary endpoints, validating that the single-incision sling is non-inferior to the transobturator sling in safety and effectiveness at 3-year follow-up.

High efficacy at 36 months1

 SolyxObtryx™ II
Composite treatment success*90.4%88.9%
Negative cough stress test94.2%91.7%
Reported improvement in SUI on the PGI-I94.2%94.4%

Low rates of adverse events1

Refer to the full list of adverse events in the Solyx 522 clinical study below.**
 SolyxObtryx™ II
Device extrusion (mesh exposure)2.8%5.0%
Urinary retention 2.8%4.3%
Pelvic pain0.7%0.0%
Dyspareunia0.7%0.0%

Improvement in sexual function2

 SolyxObtryx™ II
De novo dyspareunia was rare following both treatments 0.7% (1/141)0.0%
Statistically significant improvement in sexual function (PISQ-12) for both groups 

Patient-reported outcome measures improved in both groups, from baseline to 36 months3

 
Statistically significant improvement of leakage (UDI-6)
Statistically significant improvement in symptom severity (ISI) 
Statistically significant improvement in SUI-related quality of life (PFIQ-7) 

Postoperative variables1

 
No statistically significant difference in pain between groups at 2 weeks and pain lower than baseline at 6 weeks for both groups
Time to spontaneous void was similar between groups 

Lasting results1

 
3.5% reoperation rate for Solyx and 2.9% for Obtryx II 

*Primary endpoint was improvement in SUI at 36 months as compared to baseline by a composite objective (negative cough stress test) and subjective measure (PGI-I). 

**Solyx adverse events in this study: Solyx — Bladder spasm, device extrusion, dyspareunia, hematuria, pelvic pain, stress urinary incontinence, urinary retention, urinary tract infection, vaginal hemorrhage, vaginal infection. Obtryx II — Abdominal pain, atonic urinary bladder, constipation, device extrusion, fungal infection, mixed incontinence, pollakiuria, sensation of pressure, stress urinary incontinence, urge incontinence, urinary incontinence, urinary retention, urinary tract infection, vaginal infection, vulvovaginal pain. 

This content has been modified from its original version; this is a summary of the original publication.

This study was funded by Boston Scientific, however, Boston Scientific had no role in study design, implementation, data analysis, or writing of the manuscript.

Important safety information

Solyx indications, safety, and warnings

The following adverse events have been reported due to suburethral sling placement, any of which may be ongoing, but are not limited to: As with all implants, local irritation at the wound site and/or a foreign body response may occur, Foreign body reaction may be acute or chronic, Pain (pelvic, vaginal, groin/thigh, suprapubic, dyspareunia) (acute or chronic), Dyspareunia, Tissue responses to the mesh implant could include: erosion into organs (urethra, bladder or other surrounding tissues); exposure/extrusion into the vagina, Mesh contact with urine via erosion/ exposure/extrusion may result in stone formation, scarring/scar contracture, Necrosis, fistula formation (acute or chronic), inflammation (acute or chronic), Mesh contracture, Tissue contracture, Vaginal shortening or stenosis that may result in dyspareunia and/or sexual dysfunction, Pain with intercourse that may not resolve, Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse, Sexual dysfunction, including the inability to have intercourse. Like all foreign bodies, the mesh may potentiate an existing infection. Allergic reaction has been reported. Known risks of surgical procedures for the treatment of incontinence include: pain, ongoing pain (pelvic, vaginal, groin/thigh, suprapubic, dyspareunia), Severe, chronic pain, Apareunia, Leg weakness, Infection, De novo detrusor instability, Complete failure of the procedure/failure to resolve a patient’s stress urinary incontinence, Voiding dysfunction (incontinence, temporary or permanent lower urinary tract obstruction, difficulty urinating, pain with urination, overactive bladder, and retention), Bruising, bleeding (vaginal, hematoma formation), Abscess, Vaginal discharge, Dehiscence of vaginal incision, Edema and erythema at the wound site, Perforation or laceration of vessels, nerves, bladder, urethra or bowel may occur during placement. The following additional adverse events have been reported for the Solyx SIS System: Dysuria, Hematuria. The occurrence of these events may require surgical intervention and possible removal of the entire mesh. In some instances, these events may persist as a permanent condition after surgical intervention or other treatment. Removal of mesh or correction of mesh-related complications may involve multiple surgeries. Complete removal of mesh may not be possible and additional surgeries may not always fully correct the complications. Complications listed are specific to this study. 

References
  1. White AB, Kahn BS, Gonzalez RR, et al. Prospective study of a single-incision sling versus atransobturator sling in women with stress urinary incontinence: 3-year results. Am J Obstet Gynecol. 2020;223:545.e1–545.e11. 
  2. White AB, Anger JT, Eilber K, Kahn BS, Gonzalez RR, Rosamilia A. Female sexual function following sling surgery: a prospective parallel cohort, multi-center study of the Solyx™ Single Incision Sling System versus the Obtryx™ II Sling System. J Urol. 2021;206:696–705. 
  3. Gonzalez RR, Rosamilia A, Eilber K, Kahn BS, White AB, Anger JT. Three-year patient-reported outcomes of single-incision versus transobturator slings for female stress urinary incontinence are equivalent. Int Urogynecol J. 2023;34:2265–2274. 

Long-term mesh exposure after minimally invasive total hysterectomy and sacrocolpopexy 

The objective of this multicenter, extension study was to evaluate total and incident mesh exposure rates at least 2 years after minimally invasive total hysterectomy and sacrocolpopexy. The study evaluated women previously enrolled in a multicenter randomized trial comparing permanent versus delayed-absorbable suture with lightweight mesh for stage II or greater uterovaginal prolapse. Secondary aims were to evaluate surgical success and late adverse events. 

Of the 200 previously randomized participants, 182 were eligible, and 106 (58%) agreed to the extension study (78 in-person, 28 via questionnaire). 

  • At a mean of 3.9 years post-surgery: 
    • The rate of mesh or suture exposure was 7.7% (14 out of 182) of whom only 2 were incident cases reported after 1-year follow-up 
    • None reported vaginal bleeding or discharge, dyspareunia, or penile dyspareunia 
  • Surgical success was 87.7% (93/106).  
  • Failures included: 
    • 13.8% (13/94) by bulge symptoms 
    • 2.6% (2/78) by prolapse beyond the hymen 
    • 1.2% (1/85) by retreatment with pessary 
    • 0 by retreatment with surgery 
  • There were no serious adverse events. 

Study at a glance

7.7%

Overall exposure rate, with only 2 incident cases reported after 1-year follow-up

87%

Success rate, with low rates of bulge symptoms, prolapse behind the hymen, and retreatment

0%

There were no serious adverse events reported

Conclusion

The rate of incident mesh exposure between 1 and 3.9 years post-surgery was low, surgical success rates remained high, and no delayed serious adverse events were observed. 

Read the full study

Matthews CA, Myers EM, Henley BR, et al. Long-term mesh exposure after minimally invasive total hysterectomy and sacrocolpopexy. Int Urogynecol J. 2023;34(1):291–296. 

This content has been modified from its original version; this is a summary of the original publication.

This study was funded by Boston Scientific; however, Boston Scientific had no role in study design, implementation, data analysis, or writing of the manuscript.

Complications cited in this summary are specific to this study. Potential adverse events, any of which may be ongoing, include but are not limited to: Abscess, Adhesion formation, Allergic reaction (hypersensitivity), Bruising, Bleeding (hematoma formation), Constipation, Dehiscence, De novo detrusor instability, Dyspareunia, Pain with intercourse that may not resolve, Sexual dysfunction; including the inability to have intercourse, Erosion into organs; exposure/ extrusion into vagina, Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse, Failure to resolve a patient’s prolapse, Fistula formation (acute or chronic), Foreign body reaction (acute or chronic), Granulation tissue formation, Hemorrhage, Infection, Inflammation (acute or chronic), Injury to ureter, Scarring/scar contracture, Mesh contracture, Tissue contracture, Necrosis, Nerve injury, Organ perforation, Pain (pelvic, vaginal, groin/thigh, dyspareunia) (acute or chronic), Perforation or laceration of vessels, nerves, bladder, or bowel may occur during placement, Post-operative bowel obstruction, Prolapse/recurrent prolapse, Vaginal shortening or stenosis that may result in dyspareunia and/or sexual dysfunction, Voiding dysfunction (incontinence, temporary or permanent lower urinary tract obstruction, difficulty urinating, pain with urination, overactive bladder, and retention). The occurrence of one or more of these complications may require treatment or surgical intervention. In some instances, the complication may persist as a permanent condition after the surgical intervention or other treatment. Removal of mesh or correction of mesh-related complications may involve multiple surgeries. Complete removal of mesh may not be possible and additional surgeries may not always fully correct the complications.

Important safety information 

The following adverse events have been reported due to suburethral sling placement, any of which may be ongoing, but are not limited to: As with all implants, local irritation at the wound site and/or a foreign body response may occur, Foreign body reaction may be acute or chronic, Pain (pelvic, vaginal, groin/thigh, suprapubic, dyspareunia) (acute or chronic), Dyspareunia, Tissue responses to the mesh implant could include: erosion into organs (urethra, bladder or other surrounding tissues); exposure/extrusion into the vagina, Mesh contact with urine via erosion/ exposure/extrusion may result in stone formation, scarring/scar contracture, Necrosis, fistula formation (acute or chronic), inflammation (acute or chronic), Mesh contracture, Tissue contracture, Vaginal shortening or stenosis that may result in dyspareunia and/or sexual dysfunction, Pain with intercourse that may not resolve, Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse, Sexual dysfunction, including the inability to have intercourse. Like all foreign bodies, the mesh may potentiate an existing infection. Allergic reaction has been reported. Known risks of surgical procedures for the treatment of incontinence include: pain, ongoing pain (pelvic, vaginal, groin/thigh, suprapubic, dyspareunia), Severe, chronic pain, Apareunia, Leg weakness, Infection, De novo detrusor instability, Complete failure of the procedure/failure to resolve a patient’s stress urinary incontinence, Voiding dysfunction (incontinence, temporary or permanent lower urinary tract obstruction, difficulty urinating, pain with urination, overactive bladder, and retention), Bruising, bleeding (vaginal, hematoma formation), Abscess, Vaginal discharge, Dehiscence of vaginal incision, Edema and erythema at the wound site, Perforation or laceration of vessels, nerves, bladder, urethra or bowel may occur during placement. The following additional adverse events have been reported for the Solyx SIS System: Dysuria, Hematuria. The occurrence of these events may require surgical intervention and possible removal of the entire mesh. In some instances, these events may persist as a permanent condition after surgical intervention or other treatment. Removal of mesh or correction of mesh-related complications may involve multiple surgeries. Complete removal of mesh may not be possible and additional surgeries may not always fully correct the complications. Complications listed are specific to this study. 

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

Caution: US Federal law restricts this device to sale by or on the order of a physician trained in the use of surgical mesh for repair of stress urinary incontinence. 

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