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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("pain / chronic pain") in an adult female patient who had essure inserted (lot no.He011d6) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of fatigue, iliac fossa pain (pain in rif (right iliac fossa) every time when has periods since had sterilisation done.Constant sharp pain) and pelvic prolapse in 2022, lower gastrointestinal bleeding in 2018 and posterior vaginal prolapse, crohn's disease, rectal bleeding, skin rash, rectal bleeding, heavy periods, genital bleeding (patient reports to have had pr bleeding on and off from the past 14-years, since the birth of her first child.She has always put this down to haemorrhoids, but recently has noticed that since the birth of her last child in aug2016 the bleeding has become more persistent and she often gets blood on wiping,) and parity 5 (patient has five children and her family size is complete).Previously administered products included: microgynon [ethinylestradiol;levonorgestrel] for contraception.The patient had a family history of piles (mother) and crohn's (mother).The only concomitant product mentioned was ferrous sulfate since (b)(6) 2023.On (b)(6) 2017, the patient had essure inserted.On unknown date she experienced pelvic pain (seriousness criterion intervention required), genital haemorrhage ("abnormal bleeding"), mental disorder ("psychological issues"), headache ("headaches"), brain fog ("brain-fog"), fatigue ("fatigue") and arthralgia ("joint pain").The patient was treated with surgery (essure removal 30mar2023.) and essure was removed on (b)(6) 2023.At the time of the report, the outcome of pelvic pain was unknown.The reporter considered arthralgia, brain fog, fatigue, genital haemorrhage, headache, mental disorder and pelvic pain to be related to essure administration.The reporter commented: an additional essure insertion date provided: (b)(6) 2017.This patient has been suffering from a variety of symptoms which she contributes to the essure devices which were inserted into both fallopian tubes as part of hysteroscopic sterilisation.Patient has liaised with a support group and she has requested for the devices to be removed.Dr will initially arrange a hysterosalpingogram to ensure that the devices are still in place, and we will subsequently arrange for these to be removed laparoscopically.The claimant currently awaits removal surgery.The date of the decision to remove the product was (b)(6) 2023.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 26.928 kg/sqm.[hysterosalpingogram] on (b)(6) 2017: successful essure hysteroscopic sterilisation [ultrasound pelvis] on (b)(6) 2018: clinical details: pv bleeding.Mostly imb.No tenderness.Sterilization (b)(6) 2017 further information: menorrhagia.Rif shooting pains.Nvd's conclusion: no cause symptoms identified; on (b)(6) 2022: clinical details: pain in rif (right iliac fossa) every time when has periods since had sterilisation done.Constant sharp pain.Periods also very heavy - feels fatigue.Anaemic last year conclusion: no cause for the symptoms is seen lot number: he011d6.Udi: (b)(4).He011d6 manufacture date: 2015-10.Expiration date: 2018-10 concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records.Psychological disorder, headaches, head foggy, fatigue, joint pain added.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 26-jan-2024: mr received: reporters information, patients demographic details and lmp date and events - psychological disorder, headaches, head foggy, fatigue, joint pain were added, concomitant drug, essure removal date and action taken added and rcc updated.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data, should any new and reportable information become available from our investigation, this 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: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 18628964
• MDR Text Key: 334403369
• Report Number: 2951250-2024-00075
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Model Number: ESS305
• Device Lot Number: HE011D6
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2024
• Date Device Manufactured: 10/01/2015
• 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
• Treatment: FERROUS SULFATE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 70 KG