MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Hair Loss (1877); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Pain (1994); Sleep Dysfunction (2517); Weight Changes (2607); No Code Available (3191)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('i have pain everyday') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In april 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("painful sex"), poor quality sleep ("cant sleep well"), post-traumatic stress disorder ("ptsd"), nightmare ("nightmares"), libido decreased ("libido decreased"), coital bleeding ("bleeding after sex"), amenorrhoea ("no bleeding till february"), genital haemorrhage ("bleeding") and alopecia ("thinning hair") and was found to have weight increased ("weight gain/i have gained 80 ibs since being implanted").The patient was treated with surgery (essure removal).Essure was removed.At the time of the report, the pelvic pain, dyspareunia, poor quality sleep, post-traumatic stress disorder, nightmare, libido decreased, coital bleeding, amenorrhoea, genital haemorrhage, alopecia and weight increased outcome was unknown.The reporter considered alopecia, amenorrhoea, coital bleeding, dyspareunia, genital haemorrhage, libido decreased, nightmare, pelvic pain, poor quality sleep, post-traumatic stress disorder and weight increased to be related to essure.Concerning the injuries reported in this case, the following one was described in patient¿s social media: alopecia.Pelvic pain female, medical device removal quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: social media received.Event added: weight gain.Reporter added.On 23-mar-2020: social media: reporter, event - medical device removal were added, case became serious incident.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('i have pain everyday') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("painful sex"), poor quality sleep ("cant sleep well"), post-traumatic stress disorder ("ptsd"), nightmare ("nightmares"), libido decreased ("libido decreased"), coital bleeding ("bleeding after sex"), amenorrhoea ("no bleeding till february"), genital haemorrhage ("bleeding") and alopecia ("thinning hair") and was found to have weight increased ("weight gain / i have gained 80 ibs since being implanted").The patient was treated with surgery (essure removal).Essure was removed.At the time of the report, the pelvic pain, dyspareunia, poor quality sleep, post-traumatic stress disorder, nightmare, libido decreased, coital bleeding, amenorrhoea, genital haemorrhage, alopecia and weight increased outcome was unknown.The reporter considered alopecia, amenorrhoea, coital bleeding, dyspareunia, genital haemorrhage, libido decreased, nightmare, pelvic pain, poor quality sleep, post-traumatic stress disorder and weight increased to be related to essure.Concerning the injuries reported in this case, the following one was described in patient¿s social media: alopecia.Pelvic pain female, medical device removal.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-may-2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 10017828
• MDR Text Key: 190318029
• Report Number: 2951250-2020-06426
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

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
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 05/20/2020
• Supplement Dates FDA Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention