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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 Problems
Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
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| Patient Problems
Abdominal Pain (1685); Abscess (1690); Erosion (1750); Diarrhea (1811); Fatigue (1849); Fever (1858); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Chills (2191); Urinary Frequency (2275); Discomfort (2330); Malaise (2359); Obstruction/Occlusion (2422); Fibrosis (3167); Unspecified Mental, Emotional or Behavioural Problem (4430); Urethral Stenosis/Stricture (4501); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505)
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| Event Date 05/15/2015 |
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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 implanted on (b)(6) 2015.As reported by the patient's attorney, the patient suffered from chronic complications of mesh, including, pelvic pain, dyspareunia, vaginal pain, urinary issues, inflammation and foreign body reaction as well as the need for removal surgery.The patient claims to have suffered the following damages as a result of the implantation of the advantage device: past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.
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Manufacturer Narrative
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Date of event is approximated to (b)(6) 2015, date when the device was implanted.Initial reporter name and address: this event was reported by the patient's legal representation.(b)(6).(b)(4).
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Manufacturer Narrative
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Blocks a2 (date of birth), b5, d6b (explant date), e1 (explant physician and healthcare facility), and h6 were updated based on the additional information received on february 10, 2023.Block b3: date of event is approximated to (b)(6) 2015, date when the device was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon and healthcare facility: (b)(6).The explant physician and healthcare facility: (b)(6).Block h6: imdrf patient code e2006 captures the reportable event of erosion (mesh embedded in the bladder).Imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e1002 captures the reportable event of abdominal pain.Imdrf patient code e1405 captures the reportable event of dyspareunia.Imdrf patient code e1715 captures the reportable event of scar tissue (severe urethral scarring).Imdrf patient code e1307 captures the reportable event of urethral stenosis/stricture (urinary stricture).Imdrf patient code e0402 captures the reportable event of hypersensitivity/allergic reaction.Imdrf patient code e2326 captures the reportable event of inflammation.Imdrf patient code e1311 captures the reportable event of unspecified kidney or urinary problem.Imdrf patient code e0506 captures the reportable event of hemorrhage/blood loss/bleeding.Imdrf patient code e2313 captures the reportable event of fibrosis.Imdrf patient code e0206 captures the reportable event of unspecified mental, emotional or behavioural problem.Imdrf impact code f1903 captures the reportable event of device explantation (advantage sling removal).Imdrf impact code f1905 captures the reportable event of device revision or replacement.Imdrf impact code f12 captures the reportable event of serious injury/ illness/ impairment.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system was implanted during an advantage fit mid-urethral sling placement and cystoscopy procedure performed on (b)(6) 2015.As reported by the patient's attorney, the patient suffered from chronic complications of mesh, including, pelvic pain, dyspareunia, vaginal pain, urinary issues, inflammation, and a foreign body reaction, as well as the need for removal surgery.The patient claims to have suffered the following damages as a result of the implantation of the advantage device: past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.On (b)(6) 2019, the patient had vaginal pain, bladder pain, abdominal pain, pain with coitus, groin pain, and urinary stricture.She underwent advantage sling removal, urethral lysis, anterior colporrhaphy, abdominal paravaginal, and the removal of abdominal mesh.The patient had general anesthesia administered via a laryngeal tube.Furthermore, this was a very difficult surgery due to the severe urethral scarring from previous surgery as well as the right sling arm being scarred to the pubic bone.The previous sling was identified deep in the urethra, where it was tight and freed from the scar tissue.The mesh was incised in the midline and dissected as far laterally as possible.The dissection was carried to the contralateral side.The paravaginal space was opened on the right, and the right sling arm was followed into the right obturator muscles and noted to be very deep, and bleeding was noted from the muscle dissection.A pressure sponge was put in place.The sling on the left was freed from the underlying sub-urethral tissues and bladder wall and dissected laterally into the retropubic space as far as possible.The left sling was freed, and the mesh was felt with the scissors but was embedded in the bladder.A urethral lysis was performed with sharp dissection to further free the urethra and scar tissue.The right and left sling arms of the mesh were held with a clamp.Moreover, attention was directed to the abdominal component.A transverse skin incision was made, and this incision 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, which was then dissected free, exposing the rectus muscles.The mesh on the left and on the right was freed from the muscle tissue.The retropubic space was opened with difficulty on the right due to significant scarring in the entire right side of the retropubic space.The right sling arm was identified, followed into the obturator muscles with a very deep arc, and freed with sharp dissection.It was significant.The vaginal clamp was released, and the entire sling arm was handed off to the operative field.The left sling arm was identified and also freed from the fascia and rectus muscles.Traction of the arm elevated the bladder wall.The mesh was followed as it entered the left upper and lateral aspects of the bladder wall.Traction of the arm elevated the bladder wall, which was then dissected free.The defect in the bladder wall was closed with interrupted sutures of #2-0 dexon.The bladder was not entered.The vaginal clamp was released, and the entire left sling arm was handed off to the operative field.Copious irrigation was performed.The pathology results revealed an advantage fit tvt mesh (retropubic sling), vagina, removal: polarize synthetic mesh with chronic inflammation, foreign body reaction, hemosiderin deposition, and fibrosis.
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Manufacturer Narrative
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Blocks b5 (event description), b7 (other relevant history) and h6 (patient and impact codes) has been updated based on the additional information received on august 2, 2023.Date of event is approximated to may 15, 2015, date when the device was implanted.This event was reported by the patient's legal representation.The implanting surgeon and healthcare facility: dr.(b)(6).The explant physician and healthcare facility: dr.(b)(6).Block h6: imdrf patient code e2006 captures the reportable event of erosion (mesh embedded in the bladder).Imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e1002 captures the reportable event of abdominal pain.Imdrf patient code e1405 captures the reportable event of dyspareunia.Imdrf patient code e1715 captures the reportable event of scar tissue (severe urethral scarring).Imdrf patient code e1307 captures the reportable event of urethral stenosis/stricture (urinary stricture).Imdrf patient code e0402 captures the reportable event of hypersensitivity/allergic reaction.Imdrf patient code e2326 captures the reportable event of inflammation.Imdrf patient code e1311 captures the reportable event of unspecified kidney or urinary problem.Imdrf patient code e0506 captures the reportable event of hemorrhage/blood loss/bleeding.Imdrf patient code e2313 captures the reportable event of fibrosis.Imdrf patient code e0206 captures the reportable event of unspecified mental, emotional or behavioural problem.Imdrf patient code e172001 captures the reportable event of presence of abscess.Imdrf patient code e2311 captures the reportable event of discomfort and tenderness.Imdrf patient code e2328 captures the reportable event of small bowel obstruction.Imdrf patient code e1906 captures the reportable event of mild leukocytosis and sepsis.Imdrf patient code e1310 captures the reportable event of urinary tract infection.Imdrf patient code e0123 captures the reportable event of probable right-sided obturator neuralgia.Imdrf impact code f1903 captures the reportable event of device explantation (advantage sling removal).Imdrf impact code f1905 captures the reportable event of device revision or replacement.Imdrf impact code f12 captures the reportable event of serious injury/ illness/ impairment.Imdrf impact code f2303 captures the reportable event of patient requires a long course of intravenous antibiotic.Imdrf impact code f2203 captures the reportable event of patient had to undergo a computerized tomography scan.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system was implanted during an advantage fit mid-urethral sling placement and cystoscopy procedure performed on (b)(6) 2015.As reported by the patient's attorney, the patient suffered from chronic complications of mesh, including, pelvic pain, dyspareunia, vaginal pain, urinary issues, inflammation, and a foreign body reaction, as well as the need for removal surgery.The patient claims to have suffered the following damages as a result of the implantation of the advantage device: past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.Additional information received on february 10, 2023*** on december 11, 2019, the patient had vaginal pain, bladder pain, abdominal pain, pain with coitus, groin pain, and urinary stricture.She underwent advantage sling removal, urethral lysis, anterior colporrhaphy, abdominal paravaginal, and the removal of abdominal mesh.The patient had general anesthesia administered via a laryngeal tube.Furthermore, this was a very difficult surgery due to the severe urethral scarring from previous surgery as well as the right sling arm being scarred to the pubic bone.The previous sling was identified deep in the urethra, where it was tight and freed from the scar tissue.The mesh was incised in the midline and dissected as far laterally as possible.The dissection was carried to the contralateral side.The paravaginal space was opened on the right, and the right sling arm was followed into the right obturator muscles and noted to be very deep, and bleeding was noted from the muscle dissection.A pressure sponge was put in place.The sling on the left was freed from the underlying sub-urethral tissues and bladder wall and dissected laterally into the retropubic space as far as possible.The left sling was freed, and the mesh was felt with the scissors but was embedded in the bladder.A urethral lysis was performed with sharp dissection to further free the urethra and scar tissue.The right and left sling arms of the mesh were held with a clamp.Moreover, attention was directed to the abdominal component.A transverse skin incision was made, and this incision 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, which was then dissected free, exposing the rectus muscles.The mesh on the left and on the right was freed from the muscle tissue.The retropubic space was opened with difficulty on the right due to significant scarring in the entire right side of the retropubic space.The right sling arm was identified, followed into the obturator muscles with a very deep arc, and freed with sharp dissection.It was significant.The vaginal clamp was released, and the entire sling arm was handed off to the operative field.The left sling arm was identified and also freed from the fascia and rectus muscles.Traction of the arm elevated the bladder wall.The mesh was followed as it entered the left upper and lateral aspects of the bladder wall.Traction of the arm elevated the bladder wall, which was then dissected free.The defect in the bladder wall was closed with interrupted sutures of #2-0 dexon.The bladder was not entered.The vaginal clamp was released, and the entire left sling arm was handed off to the operative field.Copious irrigation was performed.The pathology results revealed an advantage fit tvt mesh (retropubic sling), vagina, removal: polarize synthetic mesh with chronic inflammation, foreign body reaction, hemosiderin deposition, and fibrosis.Additional information received on august 2, 2023*** the patient visited the clinic on september 12, 2019, with mesh problems.The patient stated that the symptoms started four years ago, and they have been moderate and ongoing.These symptoms occur daily and are located in the vagina area.The patient is unsure about what aggravates or relieves the symptoms.The patient added that the symptoms are poorly controlled and chronic.Four years ago, the patient had an advantage fit sling put in, and it has been causing discomfort since.Pain near the right pubic bone near the trocar site has been felt like something pinching or pulling.Additionally, the patient has experienced right-sided groin pain, which isn't directly related to any particular activity.The patient has not experienced any leakage, but she has urinary frequency with small voids.There are no symptoms of prolapse, recent urinary tract infections, or nocturia.The patient underwent an mri a few days before her visit, which revealed a descended bladder.The patient also has vulvodynia, frequent diarrhea, and a history of diverticulitis.Hematochezia is occasionally noticed by the patient.Surgery has been suggested to remove the previous advantage sling mesh, paravaginal dissection, urethral lysis, anterior colporrhaphy, and mesh from the abdominal wall and abdominal paravaginal space.The patient was informed that even after the mesh removal, there is a possibility that she may continue to experience pain, and there is no guarantee of complete pain relief.The patient was also advised that this surgery would not involve any reconstruction and would only aim to remove the mesh.A patient came to the clinic on (b)(6) 2019, complaining of pain in her right hip and thigh.She had recently undergone abdominal surgery, but there was no swelling in her leg, and her foot pulses were good and warm.The doctor found no evidence of intra-abdominal complications, and there was no swelling or tenderness.A venous doppler was performed on her right leg, which was negative for deep vein thrombosis.The doctor explained the findings to the patient, who said she felt much better despite not receiving any medication there.The physician suggested that the pain could be related to the surgery, as she was likely in stirrups for part of the bladder mesh removal.The doctor recommended that the patient follow up with her doctor that week for reevaluation.She was advised to return to the emergency room if the pain worsened or if there was any swelling or other concerns.The patient appeared stable and was discharged home in good condition.A patient visited the clinic on january 6, 2020, with a complaint of fever.She reported feeling achy and having chills since christmas, but her temperature spiked to 101.5 when she came to the clinic.The patient also reported worsening abdominal pain in the right lower quadrant, which had been slightly uncomfortable previously.She had no vomiting, diarrhea, dysuria, coughing, chest pain, or difficulty breathing.The symptoms remained unchanged at the time of the visit.Additionally, the patient has been re-evaluated and shows improvement with no other reported issues.Medically, the patient appears stable and not exhibiting any signs of toxicity.However, there are a few fluid collections within the abdomen that may indicate the presence of an abscess.Despite this concern, the patient is stable with improved blood pressure.To cover any hospital-acquired infections within the abdomen, the patient will be administered iv zosyn.Physical exam: abdominal: the patient experiences tenderness in the right lower quadrant of their abdomen, and their incision remains intact without any discharge.However, there is no tenderness in the right or left costovertebral angles and no signs of guarding or rebound.Genitourinary: there are no noticeable abnormalities in the introitus.A patient visited the clinic on (b)(6) 2020, presenting with a fever, low blood pressure, and signs of infection after undergoing abdominal surgery.A ct scan revealed fluid collections on both sides of the urinary bladder, causing it to indent.The ct scan also indicated the possibility of developing ileus or small bowel obstruction.Post-surgery, the patient had an intrabdominal fluid collection and was discharged with an abdominal drain.However, the patient developed worsening abdominal pain and fever and was sent to the emergency room.A computerized tomography scan showed a large rim-enhancing fluid collection.The patient has mild leukocytosis and experiences stable abdominal pain but still notices intermittent days of malaise and fatigue.The results of the patient's urinalysis indicate a possible urinary tract infection, while the incision exam suggests a possible case of cellulitis.Additionally, the radiology report showed the following findings: transversely oriented fluid collection with a thin rim of peripheral enhancement along the anterior pelvic wall measuring approximately 14 cm.This may reflect a postoperative seroma; however, infected fluid collection cannot be excluded.Overlying subcutaneous fat stranding and mild skin thickening.Suspected fluid collections along the right and left lateral margin of the lower urinary bladder appear to indent the bladder.For example, coronal images 41 and 42/90.The appearance of the small bowel may reflect an ileus, however, a developing small bowel obstruction is considered.No free intraperitoneal air or ascites.Small dense nodules, possibly punctate calcifications along the right margin of the endometrium, however indeterminate from this exam, and with follow-up as discussed above.The patient's antibiotic prescription was switched to unasyn on january 10, 2020, after the culture results showed the presence of methicillin-susceptible staphylococcus aureus.The physician has recommended a long course of intravenous antibiotics for the patient and advised her to undergo a computerized tomography (ct) scan before the treatment ends to assess any fluid collection.On march 12, 2020, the patient went to the clinic feeling better and energized.However, over the past two to three days, she has been experiencing diarrhea.According to the patient's ct scan on february 28, 2020, there has been interval resolution of the previously visualized fluid collection within the lower anterior pelvic wall soft tissues.There is moderate infiltration of fat in this region.The percutaneous catheter has also been removed.There is an interval decrease in the size of probable fluid collections along the right and left lateral border of the lower urinary bladder when compared to the prior exam.Due to streak artifacts at this level, a magnetic resonance imaging (mri) of the pelvis is recommended for follow-up evaluation of these probable fluid collections.On october 4, 2022, a patient came to the clinic complaining of pain in the right groin area since her sling placement.The pain worsens with movement and is accompanied by obstructive-type voiding with urine spraying.The patient also experiences dyspareunia and burning pain in the right groin and cannot wear tight clothing.Sitting for prolonged periods of time causes numbness in the perineum.The patient denies dysuria and urinary frequency, and bowel movements are unaffected.She has a history of vulvodynia and responded well to a low oxalate diet.In 2019, the sling was completely removed due to significant scarring of the retropubic space, especially on the right side.The operative report suggests that the mesh may have been more lateral on the right side than the standard, possibly causing a retropubic hematoma.The patient reports significant ecchymosis over her lower abdomen, almost up to the umbilicus, after the tvt placement.While there has been significant improvement in urination, the right groin pain persists, and the patient continues to experience dyspareunia.Impression: probable right-sided obturator neuralgia from retropubic fibrosis.
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