MAUDE Adverse Event Report: BOSTON SCIENTIFIC OBTRYX SLING TRANSOBTURATOR ; PELVIC MESH

Catalog Number M0068504000

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Fever (1858); Hair Loss (1877); Unspecified Infection (1930); Pain (1994); Swelling (2091); Thyroid Problems (2102); Complaint, Ill-Defined (2331); Impaired Healing (2378); Tooth Fracture (2428)

Event Date 12/28/2012

Event Type  Injury  

Event Description

Pt reported she suffered serious adverse side effects and complications resulting from being implanted with the obtryx transobturator sling system.She was implanted with the device on (b)(6) 2012 to treat pelvic organ prolapse(pop), stress urinary incontinence(sui) and urinary retention.She reported that the recovery took 1 year rather than the six weeks her physician allegedly promised.She stated that one year after implantation she suffered pelvic pain, reoccurring fevers, bladder infections and "felt sick".Later her tooth cracked and the front of the tooth broke off and the bottom half lodged inside the gum.She also experienced alopecia, back pain and ongoing reoccurring rashes that would not go away without a prescription.She also had foot and ankle swelling and was subsequently diagnosed with venous insufficiency.Four years later, she was diagnosed with a "slow growing" thyroid cancer.She indicated that the conditions of pop, sui and urinary retention also reoccurred.After changing her pcp 9 times, as allegedly instructed by her insurance company, she finally found a physician willing to treat her.The dr informed her that the device migrated 50% away from intended location in her body and recommend the mesh removal on (b)(6) 2017.After the removal, she reported suffering from severe pain and several bladder infections which sent her to the er as well as urgent care centers.In (b)(6) 2017, she had 4 rounds of antibiotics to treat the infection and was sick for 6 weeks and was also sick for a month in (b)(6) 2017.She stated that she was not informed of by any of her doctors that there was a less invasive treatment and was allegedly never told of the possible side effects of implantation or removal of the device.She has done a tremendous amount of research herself and would like the fda to examine the manufacturing and testing of this device and to contact her with the results of this investigation.

• Brand Name: OBTRYX SLING TRANSOBTURATOR
• Type of Device: PELVIC MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 7299525
• MDR Text Key: 101197953
• Report Number: MW5075527
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/23/2018

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: No Information
• Device Catalogue Number: M0068504000
• Device Lot Number: ML00000781
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 71 YR