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This is a spontaneous case report received from a consumer via regulatory authority (case# mw5032462) in united states on 02-jan-2014 which refers to herself a female consumer of unspecified age who had essure (fallopian tube occlusion insert) inserted and experienced heavy abnormal bleeding, abnormally large ovarian cyst, lower abdominal pain, faints, pain, loss of sex drive, vaginal discomfort, dizzy spells, collapsing, mini stroke like symptoms, weird tingling sensations in hands and feet (particularly the right side), sleep problems either extremely tired despite sleeping a ton or cant sleep, constantly depressed, lack of motivation, terribly forgetful, blurred vision, unpredictable extreme bloating, nauseous, hives on arms and legs, and cannot wear earrings as her ears start swelling and itching fiercely.No information given on consumer's history, past drugs, concurrent conditions and concomitant medication.In 2011 the consumer had essure (fallopian tube occlusion insert) inserted for permanent birth control.Within less than a year, the consumer developed heavy abnormal bleeding.Her gynecologist found an abnormally large ovarian cyst that would require surgery.In the few months it took to get her set up, she started having lower abdominal pain which was then attributed to the cysts and had a couple of faints.In 2012, she underwent surgery and tests showed the removed cyst was benign.The pain started up again a month later, the abnormal heavy bleeding for weeks continued and other health issues began showing themselves.However, health insurance ran out and she have since suffered with extreme pain, loss of sex drive, vaginal discomfort, heavy bleeding, dizzy spells, collapsing, mini stroke like symptoms, weird tingling sensations in hands and feet (particularly the right side), sleep problems either extremely tired despite sleeping a ton or can't sleep, constantly depressed, lack of motivation, terribly forgetful, blurred vision, unpredictable extreme bloating, nauseous, hives on arms and legs, recently, cannot wear her earrings as her ears start swelling and itching fiercely.The event outcome provided was hospitalization.She believed firmly that she was suffering from side effects from essure that were never brought to her attention.She was intending upon getting a hysterectomy to have essure removed.Reporter causality: the relationship between events and essure is related.**follow-up received on 26-jan-2014: product technical complaint investigation and final assessment received.This adverse event report is related to a product technical complaint (ptc) - incident report.The bayer reference number for the ptc report is: (b)(4) and the local number is (b)(4).If the outcome of the ptc investigation confirms a quality defect or a counterfeit, this will be communicated in a follow-up report.Final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.No capa investigation is required per criteria established in wi-03635, "processing essure cases in dev@com." fda evaluation codes: method: no testing methods performed.Results: no results available since no evaluation performed.Conclusions: unable to confirm complaint; device not returned.Medical assessment: the medical events reported are not indicative for a quality defect per se.The medical events were reported with an occurrence over a period of 2 years and are of broad nature.The majority of the reported medical events were assessed as being not related to essure or considered not assessable.No complaint sample was provided for further technical investigation.No batch number was reported.Without this information neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible.The technical investigation concluded "unconfirmed quality defect".In summary, based on the available information there is no reason to suspect quality defect.Follow-up information was received on 23-jan-2014.Consumer's date of birth, weight and height were provided.This report refers to a (b)(6) female consumer.Concomitant condition included obesity (bmi (b)(6)).She denied any previous gynecological problems or procedures.She had 06 pregnancies, 03 kids, 03 miscarriages, premature labor for my last daughter when she ended up having flu and high blood pressure.Relevant medical history or concurrent conditions included asthma.Around (b)(6) 2010 essure was inserted (previously reported as 2011) 6-8 weeks after her last delivery.She didn't use anything as back-up contraception after essure insertion and before total occlusion confirmation.Hsg (hysterosalpingogram) test was not performed since her insurance ran out.On unspecified date she experienced breast pain mostly in nipples, feels like lactating and funky bleeding for 3 weeks with spacing in between.Other symptoms started around (b)(6) 2011.She didn't really notice them until (b)(6) 2012.In (b)(6) 2012 she got really dizzy and collapsed, things got nastier and nastier after that.She went to the doctor where they discovered an ovarian cyst.She doesn't know whether or not she can stay on her feet.The outcome was ongoing.Her doctor stated that her bleeding should have cleared in 3 months and it never did.On unspecified date the cyst was laparoscopically removed.They went into her belly button cut cyst off the ovary.She still kept her ovaries.No hospitalization was required.Essure devices have not been removed.She believes the events were caused by essure since she was healthy before it was inserted.No further information was provided.**follow-up received on 10-feb-2014 according to the consumer, she will meet a general doctor at the end of february.She would like to find a gynecologist and have essure removed.She will call back to provide new information once the removal procedure has been scheduled/performed.Follow-up information received on 11-aug-2015: this case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting taking place in (b)(4) 2015 ((b)(4)).Consumer reported that after three difficult pregnancies and three miscarriages, she decided her family was complete.Her youngest was only about six months old and she couldn't afford the down time of a traditional tubal.Consumer reported she got essure done in 2010, but by the end of 2011 her periods were getting longer and off.By the beginning of 2012, she was bleeding for weeks at a time with only a few days between.She also reported a massive acne breakout that was so bad her clothes would be dotted with blood and it hurt when people touched her because skin was so covered with acne.She was experiencing abnormally large ovarian cyst.She was scheduled a surgery in june.She started having sharp stabbing pains in her lower left abdomen, dizzy and collapsed.The surgery came and went, but the bleeding continued and the pain increased.At her six week checkup, her doctor assured the bleeding should clear up by two months.She bled for three weeks at a time, had miserable periods where she would pass large clumps, was sick to her stomach, and had chronic diarrhea.She got a few days reprieve and it would start up again.The pain, mild at first, became unbearable.She had a high pain tolerance but after two years of daily agony, she needed to take pain meds (which i hadn't needed after her surgery) at least once a week so she could actually get comfortable enough to sleep.The weird collapsing spells became more common to the point she quit driving for over a year.Her hair started to fall out, her teeth cracked and broke, her skin would break out in hive rashes without any warning, she became allergic to her jewelry, she couldn't remember anything, her brain felt like mush, she was depressed, sick all the time, she couldn't sleep but she was so tired she could barely move, intercourse rarely happened and when it did, it almost always had to end early cause she would be in so much pain and start bleeding; her migraines became blindingly excruciating and more common.She went to a new gynecologist and when she did the first checkup, the consumer cried from the pain of her fingers.She proposed a hysterectomy and after the proper tests she removed everything but her right ovary.Her left was too riddled with cysts and swollen to save.The consumer stated it was instant relief.She stated the hysterectomy saved her life.Before the surgery she could hardly handle sitting in a car because it hurt so bad, and at the time of report she could jet-ski, quad and do the things that made her happy again.She hadn't had a single passing out moment, her hair had grown back in, and it took a while but she could even wear some of jewelry again.The only cost was that she had to have a hysterectomy, at (b)(6).Company causality comment: this spontaneous case report refers to a female consumer of not reported age who had inserted essure (fallopian tube occlusion insert) and experienced sharp stabbing pains in her lower left abdomen, heavy abnormal bleeding, abnormally large ovarian cyst, and mini stroke like symptoms.A hysterectomy was performed along with right ovarian removal.All these events are serious due to their medical importance.Ovarian cyst was also serious due to hospitalization.The lower pain in abdomen is serious due to required intervention.Pain in lower abdomen and heavy abnormal bleeding are listed events in the reference safety information for essure while abnormally large ovarian cyst and mini stroke like symptoms are unlisted.As the temporal relationship between heavy abnormal bleeding and pain in lower abdomen and essure use is suggestive, causality is assessed as related.Considering the pathophysiology of ovarian cyst and mini stroke like symptoms and localized action of essure in the fallopian tubes, it is unlikely that essure would cause these events.Additionally, non-serious events were reported.This case is regarded as incident since a device removal was required (implied).Product technical complaint investigation: based on the available information there is no reason to suspect quality defect.
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