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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE INSERT, TUBAL OCCLUSION

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BAYER PHARMA AG ESSURE INSERT, TUBAL OCCLUSION Back to Search Results
Model Number ESS205
Event Type  Injury  
Event Description

This spontaneous case report was received from a consumer in the united states on (b)(6)2014 via company internet site. The report refers to the reporting female consumer who had essure (fallopian tube occlusion insert) inserted at age (b)(6) and experienced bleeds during sex, has blood clots the size of quarters coming out all over her husband during sex, painful cramps, hair loss, when she has sex it hurts so bad, gets rashes all over her body, major swelling all over, no sleep because it feels like her tubes are going to explode. No information was given on consumer's drug history, concomitant medication. The consumer's medical history/concurrent conditions included being healthy, having four kids. On an unspecified date in 2006, the consumer had essure (fallopian tube occlusion insert) inserted. Consumer reported essure has destroyed her life, she is not the same person. She bleeds during sex, has blood clots the size of quarters coming out all over her husband during sex. Painful cramps, hair loss. When she has sex it hurts so bad that she just wants to cry. She gets rashes all over her body, major swelling all over, no sleep because it feels like her tubes are going to explode. She does not want to go outside and play with her children. Essure has ruined her life, her marriage, her womanhood. She got to get all her female parts taken out to feel normal again, to enjoy the small things of life again. Follow-up information received on (b)(6) 2014: the local health authority was added as reporter under the reference number (b)(4). In 2006 she had the essure birth control implanted. She stated that she has had nothing but issues with that. She experienced bleeding, painful sexual intercourse, hair falling out, bloating, she looked like she was 6 months pregnant; weight has gone up so much and back down and back up. It was reported that she got to have all her lady parts taken out because one of the devices has torn thru and has managed to go to another body part where it should not be. Her mood swings have been horrible, to the point where she has thought about ending her life; the pain was horrible. No further information was provided. Follow-up information received on (b)(6) 2014 from social media: the consumer reported she experienced pain, bleeding clots the size of quarter or bigger, she was not having sexual relations, loosing hair, swelling like 5 months pregnant, issued with heart, liver and inside her on fire all the time. She stated essure has ruined her life. Follow-up information received on (b)(6) 2014: unsuccessful follow-up attempt. The case is potential legal case. Follow-up information received on (b)(6) -2014: unsuccessful follow-up attempt. Follow-up received on (b)(6) 2015: information received from consumer via regulatory authority ((b)(4)) states that she had essure model 205 (lot number 620734) placed in 2008 (discrepant information). From the time she woke up in 2014 (unspecified date) she has been in pain. Consumer also reported gaining over 100 pounds, blood clots the size of golf balls, hair has fallen out, eye lashes disappeared and no sex drive. Consumer informed that when she did have sex it was so painful and she would bleed for days after sex. She had to have 2 ablations done because the doctors could not figure out why she was in so much pain. In addition, consumer reported that she got pregnant twice (both ending in death of fetus). She had several panic attacks because of the pain and reports heart issues and cyst on her ovaries the size of quarters or bigger. According to consumer, essure migrated through her tubes and end up wrapped around other organs and states now that the devices are out she feels 100% better. Essure was explanted on (b)(6) 2014 and all her side effects were gone. Consumer states that the swelling all over her body and the pain that she was in every day were caused by essure. Case upgraded to incident. Consumer's second pregnancy case number is (b)(4). Ptc investigation result received on (b)(4) 2015 ptc global number (b)(4). Final assessment since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint. Typically, we would inspect the micro-insert to look for any manufacturing deficiencies. In this case, we conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements. We are unable to confirm any quality defect or device malfunction at this time. No new failure mode has been identified. Medical assessment this ptc was initiated due to request for confirmation of quality. The ae case refers also to a lack of efficacy. Contraceptive failure may occur under the use of any contraceptive and is not indicative of a quality defect per se. The reported adverse events considered related are not indicative of a quality deficit per se. No similar ae case reports have been received to date in relation to the reported batch. No batch signal could be identified. The batch documentation of the reported batch was reviewed. No complaint sample was provided for further technical investigation. The technical assessment concluded unconfirmed quality defect. In summary, there is no reason to suspect a causal relationship to a potential quality deficit as based on this report. Follow up information received on (b)(6) 2015: case considered closed. Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who became pregnant twice after essure insertion, both pregnancies ended in death of the fetus. Additionally, one of the devices has torn thru (essure migrated through her tubes) and end up wrapped around the organs and she had bleed during sex/ blood clots the size of quarters come out all over her husband, blood clots the size of golf balls and horrible mood swings, to the point where she has thought about ending her life (regarded as depression suicidal). She was submitted to 2 ablations and had essure removed. All events were considered serious due to medical importance and are listed in essure's reference safety information, except for depression suicidal and fetal death, which are unlisted. Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place. Some of these pregnancies occurred due to patient non-compliance including failure to return for the essure confirmation test (hsg). In this particular case, no information was provided about hsg. The patient stated on essure migrated through her tube. This fallopian tube perforation could be an alternative explanation for the reported device failure (pregnancy). However, since its mechanism is unknown (if perforation occurred before or after pregnancy onset), causality with essure cannot be excluded. Regarding fetal death, limited information was provided, however considering the vast majority of spontaneous abortions occurs in the first trimester of pregnancy due to fetal chromosomal abnormalities, causality with essure is considered unlikely. For the other events, consumer stated all her side effects were gone after essure removal. Therefore, causality with the suspect insert cannot be excluded; and due to the required interventions for events treatment (ablation and essure removal) this case was regarded as incident. The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit as based on this report.

 
Manufacturer Narrative

Correction on 02-mar-2016 following company internal coding review: the event swelling in hips and back was split and coded to pt swelling nos and pt joint swelling. Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who became pregnant twice after essure insertion, both pregnancies ended in death of the fetus/ miscarriage. Additionally, one of the devices has torn thru (essure migrated through her tubes) and end up wrapped around the organs and she had bleed during sex/ blood clots the size of quarters come out all over her husband, blood clots the size of golf balls and horrible mood swings, to the point where she has thought about ending her life (regarded as depression suicidal). She was submitted to 2 ablations and had essure removed. All events were considered serious due to medical importance and are listed in essure's reference safety information, except for depression suicidal and fetal death/ miscarriage, which are unlisted. Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place. In this particular case, no information was provided about hsg. The patient stated essure migrated through her tube. This fallopian tube perforation could be an alternative explanation for the device failure (pregnancy). However, since its mechanism is unknown (if perforation occurred before or after pregnancy onset), causality with essure cannot be excluded. Regarding fetal death/ miscarriage, limited information was provided. Considering that the vast majority of spontaneous abortions occurs in the first trimester of pregnancy due to fetal chromosomal abnormalities, causality with essure is considered unlikely. For the other events, consumer stated all her side effects were gone after essure removal. Therefore, causality with the suspect insert cannot be excluded; and due to the required interventions for events treatment (ablation and essure removal) this case was regarded as incident. The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit as based on this report.

 
Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

 
Manufacturer Narrative

Follow-up received on 17-feb-2016 it was reported that she is allergic to oral prednisone, steroid injections, ibuprofen, baclofen, diclofenac, etodolac and robaxin. She had nonstop muscle spasms, nerve damage in back (arthritis), spondylosis has sped up. She was on nerve medication and has had multiple injections as well as every therapy possible to deal with the pain. She also experienced rashes all over back and belly, swelling in belly, hips and back, weight gain, nonstop pelvic pain she had to have ultrasounds for and a mri which found a mass from scar tissue, bleeding between periods with giant clots during monthly cycle, miscarriage and low vitamin d. She had been diagnosed with ibs as well, after having a colonoscopy. Correction on 02-mar-2016 following company internal coding review: the event swelling in hips and back was split and coded to pt swelling nos and pt joint swelling. Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who became pregnant twice after essure insertion, both pregnancies ended in death of the fetus/ miscarriage. Additionally, one of the devices has torn thru (essure migrated through her tubes) and end up wrapped around the organs and she had bleed during sex/ blood clots the size of quarters come out all over her husband, blood clots the size of golf balls and horrible mood swings, to the point where she has thought about ending her life (regarded as depression suicidal). She was submitted to 2 ablations and had essure removed. All events were considered serious due to medical importance and are listed in essure's reference safety information, except for depression suicidal and fetal death/ miscarriage, which are unlisted. Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place. In this particular case, no information was provided about hsg. The patient stated essure migrated through her tube. This fallopian tube perforation could be an alternative explanation for the device failure (pregnancy). However, since its mechanism is unknown (if perforation occurred before or after pregnancy onset), causality with essure cannot be excluded. Regarding fetal death/ miscarriage, limited information was provided. Considering that the vast majority of spontaneous abortions occurs in the first trimester of pregnancy due to fetal chromosomal abnormalities, causality with essure is considered unlikely. For the other events, consumer stated all her side effects were gone after essure removal. Therefore, causality with the suspect insert cannot be excluded; and due to the required interventions for events treatment (ablation and essure removal) this case was regarded as incident. The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit as based on this report.

 
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Brand NameESSURE
Type of DeviceINSERT, TUBAL OCCLUSION
Manufacturer (Section D)
BAYER PHARMA AG
müllerstr. 178
berlin, CA 13353
GERMANY 13353
Manufacturer (Section G)
BAYER PHARMA AG
müllerstr. 178
berlin, CA 13353
GERMANY 13353
Manufacturer Contact
k shaw lamberson
100 bayer blvd.
p.o. box 915
whippany , NJ 07981-0915
MDR Report Key4927581
Report Number2951250-2015-00520
Device Sequence Number1
Product CodeHHS
Report Source Manufacturer
Source Type Other,Consumer,CONSUMER,OTHER
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 01/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/21/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date06/01/2008
Device MODEL NumberESS205
Device LOT Number620734
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/21/2015 Patient Sequence Number: 1
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