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

Model Number ESS205

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Irritation (1941); Itching Sensation (1943); Menstrual Irregularities (1959); Swelling (2091); Myalgia (2238); Urticaria (2278); Discomfort (2330); Toxicity (2333); Arthralgia (2355)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of allergy to metals ("allergic reaction to nickel") and urticaria ("hives") in a (b)(6) female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.In 2003, the patient had essure (ess205) inserted.On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), urticaria (seriousness criterion medically significant), menstruation irregular ("irregular menstruation with clots"), headache ("headache"), arthralgia ("joint pain"), myalgia ("muscle pain"), abdominal pain upper ("stomachache"), pruritus ("itching"), oral discomfort ("burning sensation in mouth"), vaginal infection ("vaginal infections every month"), alopecia ("excessive hair loss"), sexual dysfunction ("sexual dysfunction"), eye irritation ("burning sensation in eyes"), swelling ("swelling"), metrorrhagia ("metrorrhagia"), pelvic pain ("pelvic pain"), fatigue ("tiredness"), mental disorder ("psychological sequels") and adverse event ("aesthetic damage (unspecified)").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2016 for removing essure).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the allergy to metals, urticaria, menstruation irregular, headache, arthralgia, myalgia, abdominal pain upper, pruritus, oral discomfort, vaginal infection, alopecia, sexual dysfunction, eye irritation, swelling, metrorrhagia, fatigue, mental disorder and adverse event outcome was unknown.The reporter considered abdominal pain upper, adverse event, allergy to metals, alopecia, arthralgia, eye irritation, fatigue, headache, menstruation irregular, mental disorder, metrorrhagia, myalgia, oral discomfort, pelvic pain, pruritus, sexual dysfunction, swelling, urticaria and vaginal infection to be related to essure (ess205).The reporter commented: as consequence of allergic reaction derived of components of device, patient underwent bilateral salpingectomy on (b)(6) 2016 for removing essure.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred term: allergy to metals.The analysis in the global safety database revealed 429 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Quality-safety evaluation of ptc: ptc global number: (b)(4).Sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on (b)(6) 2018: events "swelling, metrorrhagia, pelvic pain, tiredness and allergic reaction to nickel, aesthetic damage, psychological sequels" were added.Case upgraded to incident.Start and stop date of essure added.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of allergy to metals ('allergic reaction to nickel') in a 43-year-old female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.In 2003, the patient had essure (ess205) inserted.On an unknown date, the patient experienced allergy to metals (seriousness criterion intervention required), pelvic pain ("pelvic pain"), urticaria ("hives"), pruritus ("itching"), intermenstrual bleeding ("metrorrhagia"), menstruation irregular ("irregular menstruation with clots"), headache ("headache"), vaginal infection ("vaginal infections every month"), sexual dysfunction ("sexual dysfunction"), musculoskeletal pain ("joint and muscle pain"), abdominal pain upper ("stomachache"), oral discomfort ("burning sensation in mouth"), alopecia ("excessive hair loss"), eye irritation ("burning sensation in eyes"), swelling ("swelling"), fatigue ("tiredness") and mental disorder ("psychological sequels").The patient was treated with surgery (bilateral salpingectomy, essure removal).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the allergy to metals, urticaria, pruritus, intermenstrual bleeding, menstruation irregular, headache, vaginal infection, sexual dysfunction, musculoskeletal pain, abdominal pain upper, oral discomfort, alopecia, eye irritation, swelling, fatigue and mental disorder outcome was unknown.The reporter considered abdominal pain upper, allergy to metals, alopecia, eye irritation, fatigue, headache, intermenstrual bleeding, menstruation irregular, mental disorder, musculoskeletal pain, oral discomfort, pelvic pain, pruritus, sexual dysfunction, swelling, urticaria and vaginal infection to be related to essure (ess205).The reporter commented: as consequence of allergic reaction derived from the components of device, patient underwent bilateral salpingectomy on (b)(6) 2016 for removing essure.Esthetic damage (unspecified) was also reported.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-mar-2022: the consumer´s name was provided, no new clinical information received, update to imdrf/fda codes.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 allergy to metals ('allergic reaction to nickel') in a 43-year-old female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.In 2003, the patient had essure (ess205) inserted.On an unknown date, the patient experienced allergy to metals (seriousness criterion intervention required), pelvic pain ("pelvic pain"), urticaria ("hives"), pruritus ("itching"), intermenstrual bleeding ("metrorrhagia"), menstruation irregular ("irregular menstruation with clots"), headache ("headache"), vaginal infection ("vaginal infections every month"), sexual dysfunction ("sexual dysfunction"), musculoskeletal pain ("joint and muscle pain"), abdominal pain upper ("stomachache"), oral discomfort ("burning sensation in mouth"), alopecia ("excessive hair loss"), eye irritation ("burning sensation in eyes"), swelling ("swelling"), fatigue ("tiredness") and mental disorder ("psychological sequels").The patient was treated with surgery (bilateral salpingectomy, essure removal).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the allergy to metals, urticaria, pruritus, intermenstrual bleeding, menstruation irregular, headache, vaginal infection, sexual dysfunction, musculoskeletal pain, abdominal pain upper, oral discomfort, alopecia, eye irritation, swelling, fatigue and mental disorder outcome was unknown.The reporter considered abdominal pain upper, allergy to metals, alopecia, eye irritation, fatigue, headache, intermenstrual bleeding, menstruation irregular, mental disorder, musculoskeletal pain, oral discomfort, pelvic pain, pruritus, sexual dysfunction, swelling, urticaria and vaginal infection to be related to essure (ess205).The reporter commented: as consequence of allergic reaction derived from the components of device, patient underwent bilateral salpingectomy on (b)(6) 2016 for removing essure.Esthetic damage (unspecified) was also reported.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 11-apr-2022: 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
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj, NJ 07981
• MDR Report Key: 7565804
• MDR Text Key: 109994998
• Report Number: 2951250-2018-02466
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: P020014
• 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,Followup
• Report Date: 04/12/2022

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
• Device Model Number: ESS205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 03/21/2022; 04/11/2022
• Supplement Dates FDA Received: 03/29/2022; 04/12/2022
• 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; Other
• Patient Age: 43 YR
• Patient Sex: Female