Last night was one of those night where I haven’t been able to sleep. Thankfully, those nights are becoming much less frequent because I have finally let go of the fear I have from a very recently clinical diagnosis. I have PTSD. There, I said it and I am no longer afraid of the condition.
When many of you think of PTSD, you instantly think of someone in the military who has most likely served in a combative situation. One of my dear friends suffers from PTSD; a car backfiring sounds like a gunshot and for him, triggers a flashback. My story is nothing like that; I wasn’t in the military; I’ve never even heard a gunshot. My PTSD stems from traumatic injuries I sustained from Essure. I will always be amazed at the extent of the damage caused by Essure. It now officially extends beyond the physical injuries which I have endured. I’m not alone; there are over 10,000 women who suffer like I do, who simply want their lives and health back. We know, deep down, we’ll never be who we were before our fateful day that we chose Essure.
When you think of PTSD, you don’t think of fame. You think of some sort of trauma. You can imagine my complete disgust when I read an article on Fox News (link below) where Alanis Morissette claimed that fame gave her PTSD. FAME… I struggle with how someone famous could have nightmares from the red carpet, touring the world performing for her adoring fans, making millions from her record deals, being showered with gifts so you can seen wearing the latest and greatest from some designer; yeah that sure sounds traumatic to me.
Nightmares and flashbacks taking me back to the day I almost died; that’s my PTSD. I used to be afraid of it and now, I welcome it. In all this, I remembered something very important –I am still here to experience the nightmares; I am still here to experience the flashbacks. In the end, I am still here. For those of us who suffer from PTSD, regardless of the source of our trauma, her use of the term strips away the legitimacy of our condition; our suffering; our stories; our trauma.
She can walk away from her fame; she can say she’s done. Sadly, I can’t. As I type this entry, I am home recovering from my latest surgery performed one week ago. I don’t even know how many I’ve had anymore as the number doesn’t matter anymore. One surgery from defective birth control is too many, and for so many of Essure victims, it is more than one. This procedure, performed by a surgeon who specializes in Pelvic and Abdominal Reconstruction, was to remove scar tissue, fragments, and a mass that size of a grapefruit from my lower abdomen. All this from a defective birth control device.
I wish I could walk in the shoes of Alanis Morissette and say I’m traumatized by fame. Those aren’t my shoes. My shoes are to walk everyday living the best life I can not knowing how long I’ll be pain free this time, not knowing how long I’ll be healthy; not knowing if I’ll need another surgery. But at least I’m here to take the walk and I take it with my PTSD and with my 10,000 e-sisters who walk the same journey I did.
Alanis, want to walk in my shoes? This is one jagged little pill you couldn’t handle. You couldn’t last a day in my shoes.
http://www.foxnews.com/entertainment/2014/09/17/alanis-morissette-said-fame-caused-her-to-have-ptsd/
Thursday, September 18, 2014
Tuesday, June 17, 2014
My Friend Kim
I am so blessed to be able to say Kim Hudak is my friend. Kim is one of my e-sisters and if it wasn’t for Essure, I would have never met her. Kim’s Essure story is so remarkable, and her strength and courage is even more remarkable.
Her journey with Essure began in 2000 when she signed up to be a clinical trial participant. Just like so many, she wanted to avoid surgery and Essure is marketed as non-surgical. She became sick almost immediately and the doctors dismissed her symptoms. They weren’t gynecological nature so it couldn’t be Essure; at least that is what they were telling her.
Her symptoms started with sharp pains in my rear pelvic region which were accompanied by generalized achiness, fatigue and severe PMS symptoms. Sadly, she didn’t get better. She was exhausted all the time and did not want to leave the house. Kim went from being happy, healthy and normal to this shell of person who so sick all of the time.
Since she was implanted, she has been diagnosed with fibromyalgia, hyper-extensive joint disorder, restless leg syndrome and chronic fatigue disorder and has been prescribed a variety of medications that range from pain killers to muscle relaxers and even anti-depressants accompanied by drugs to treat inflammation. Nothing was helping and Kim, sadly thought and truly believed her days on this Earth were numbered. Many nights, Kim would go to bed in fear of not waking up the next morning.
Kim had always suspected Essure was her problem, however, she always second guessed herself since every single medical professional she spoke with insisted it was not. A few years ago, Angie found Kim when she posted information on another page. There were only 500 women in our Essure Problems Facebook group at the time, and we were all like Kim. We were all suffering the same symptoms and we suddenly realized that we were alone.
Kim had true validation that Essure was her problem and she went to work on getting my health back. She reached out to the study doctor, Dr. Linda Bradley, who is still practicing. She never returned my phone calls, faxes or emails. She then tried to get her records to review with my family doctor and gynecologist and she was only sent 8 pages. It took a couple months, and with the help of the media, she finally received her full medical records, almost 60 total pages of documentation. To say she was shocked by what she read in the file was an understatement. She was shocked to read that her information was altered to reflect that she was doing well with the coils. The entire time she was complaining of issues that were documented, her records for the study said she was doing well. Notations were even made that the doctor suspected a nickel allergy severe enough to warrant removal of the devices, however, this was never mentioned to Kim and it was not included in the study notes.
In October of 2013, Kim underwent a hysterectomy to remove the Essure. She did experience a short period where she felt some relief; however, improper removal has left fragments of Essure in her body. Her health is again declining and she isn’t sure if a resolution will ever be found.
A few people have called me a hero because I gave a speech in German. My act of “heroism” pales in comparison to Kim. The few days I spent with Kim in DC reminded me of different everyone’s Essure story is, and how different the suffering is for all of us. For Kim, some days are better than others; some days she is able to hide that she isn’t feeling well. Then there are the days that she just fights to function. We were talking about yoga, and she said “can’t do a downward dog with these elbows.” Something as basic as extending her arm, something many of us do all the time, isn’t possible because of the inflammation in her joints. She has days where she simply can’t eat; swallowing is uncomfortable. She is okay in the morning, just okay, and that is on a good day. By the afternoon, she is fighting to make it through the rest of the day. In the evening, the umbrella brought with her for the rain became her walking stick.
Last Thursday, I was able to watch my friend Kim as she was a participant in a senate briefing speaking about the adverse implications of FDA approvals. This was the first time I heard Kim speak in front of an audience, and I simply don’t have words to describe how proud I am of her. There was not a dry eye in the room. I knew her story, and she even got me teary. The speech we prepared ended up being too long, so she just ‘winged’ it. She was so genuine, so sincere, and so open with her story, her fight and even her battle.
Kim is my hero and I’m so thankful that the tragedy of Essure brought us together.
Here's the link to her speaking.
https://www.youtube.com/watch?v=xHxbTEdzGUE&feature=youtu.be
Her journey with Essure began in 2000 when she signed up to be a clinical trial participant. Just like so many, she wanted to avoid surgery and Essure is marketed as non-surgical. She became sick almost immediately and the doctors dismissed her symptoms. They weren’t gynecological nature so it couldn’t be Essure; at least that is what they were telling her.
Her symptoms started with sharp pains in my rear pelvic region which were accompanied by generalized achiness, fatigue and severe PMS symptoms. Sadly, she didn’t get better. She was exhausted all the time and did not want to leave the house. Kim went from being happy, healthy and normal to this shell of person who so sick all of the time.
Since she was implanted, she has been diagnosed with fibromyalgia, hyper-extensive joint disorder, restless leg syndrome and chronic fatigue disorder and has been prescribed a variety of medications that range from pain killers to muscle relaxers and even anti-depressants accompanied by drugs to treat inflammation. Nothing was helping and Kim, sadly thought and truly believed her days on this Earth were numbered. Many nights, Kim would go to bed in fear of not waking up the next morning.
Kim had always suspected Essure was her problem, however, she always second guessed herself since every single medical professional she spoke with insisted it was not. A few years ago, Angie found Kim when she posted information on another page. There were only 500 women in our Essure Problems Facebook group at the time, and we were all like Kim. We were all suffering the same symptoms and we suddenly realized that we were alone.
Kim had true validation that Essure was her problem and she went to work on getting my health back. She reached out to the study doctor, Dr. Linda Bradley, who is still practicing. She never returned my phone calls, faxes or emails. She then tried to get her records to review with my family doctor and gynecologist and she was only sent 8 pages. It took a couple months, and with the help of the media, she finally received her full medical records, almost 60 total pages of documentation. To say she was shocked by what she read in the file was an understatement. She was shocked to read that her information was altered to reflect that she was doing well with the coils. The entire time she was complaining of issues that were documented, her records for the study said she was doing well. Notations were even made that the doctor suspected a nickel allergy severe enough to warrant removal of the devices, however, this was never mentioned to Kim and it was not included in the study notes.
In October of 2013, Kim underwent a hysterectomy to remove the Essure. She did experience a short period where she felt some relief; however, improper removal has left fragments of Essure in her body. Her health is again declining and she isn’t sure if a resolution will ever be found.
A few people have called me a hero because I gave a speech in German. My act of “heroism” pales in comparison to Kim. The few days I spent with Kim in DC reminded me of different everyone’s Essure story is, and how different the suffering is for all of us. For Kim, some days are better than others; some days she is able to hide that she isn’t feeling well. Then there are the days that she just fights to function. We were talking about yoga, and she said “can’t do a downward dog with these elbows.” Something as basic as extending her arm, something many of us do all the time, isn’t possible because of the inflammation in her joints. She has days where she simply can’t eat; swallowing is uncomfortable. She is okay in the morning, just okay, and that is on a good day. By the afternoon, she is fighting to make it through the rest of the day. In the evening, the umbrella brought with her for the rain became her walking stick.
Last Thursday, I was able to watch my friend Kim as she was a participant in a senate briefing speaking about the adverse implications of FDA approvals. This was the first time I heard Kim speak in front of an audience, and I simply don’t have words to describe how proud I am of her. There was not a dry eye in the room. I knew her story, and she even got me teary. The speech we prepared ended up being too long, so she just ‘winged’ it. She was so genuine, so sincere, and so open with her story, her fight and even her battle.
Kim is my hero and I’m so thankful that the tragedy of Essure brought us together.
Here's the link to her speaking.
https://www.youtube.com/watch?v=xHxbTEdzGUE&feature=youtu.be
Sunday, June 15, 2014
If It Wasn't For My Dad....
Hi everyone,
Its been over a month since I returned from speaking in Germany and the events of that trip are still making news. I actually came down with a horrible pneumonia and was in bed for over two weeks. I had to take three courses of antibiotics and I'm still using an inhaler, but I'm over the worst part, finally.
A reporter from Germany flew to the states and interviewed both me and Erin Brockovich for an upcoming story. That interview was unlike any other I've done since I embarked on a journey against Essure with my e-sisters. We sat in my living room with our shoes off eating pretzels. She really wanted to know more about me and what makes me tick. Its actually thoughts of that interview which have me wanting to share more about how I became the fearless one who just doesn't know how to back down from a challenge. I am who I am because of my dad.
He was the product of dirt poor farmers in Batavia, New York. Sadly, he and his siblings ended up in a children's home because his parents couldn't provide for them. As soon as he was able to leave the home, he enlisted in the military, specifically the United States Air Force where he was a Tactical Munitions Specialist. Those are fancy words to describe someone who built and dismantled bombs and designed guns. He served in Vietnam and a few other lesser known conflicts. Basically, anywhere they needed bombs put together, my dad was there. He served in the military for over 20 years and went close to home, Cheektowaga, New York, to live after he retired.
In June of 2002, my dad started complaining of headaches. A few short months later, in October, we learned after a battery of tests that the headaches were from a malignant squamous cell tumor in his brain. We were told that he had, at more, three months to live. We lost him in December, and even though we knew it was coming, it was the words he shared with him in those few short months that made the biggest impact on who I am today.
My dad made sure he taught me every life lesson he could think of and I'll never forget anything. Things like know the enemy, don't ever be afraid to stand up for what's right (all of us) even when no one wants to listen; if the doors are closed and the windows are locked, bust them down; sometimes you just have to piss people off to get them to listen; don't ever be afraid of failure; never miss an opportunity to do something for the greater good; be the one to do something that no one else can do because someone has to stand up and do it, and if you don't, no one else will; use your head, but act with your heart.
When I was prepping for Germany and when I stood on the stage, it was my dad's words in my head and all of you in my heart... Without these little lessons from my dad, I would have never been able to learn German in two weeks and give a speech in the lion's den.
Sadly, I wish my dad would have been able to prepare me for the hardest part of giving a speech that has gotten so much attention - how to deal with people who are jealous of the attention I'm suddenly getting. I don't want to be the story; the message is the story and the suffering that Essure has caused is the real story. There are even some who think I'm only in this for me and I can't express how much this actually hurts. I sacrificed so much time away from my family working with a public speaking coach and then working with a German tutor so I could give the speech in German or we wouldn't be heard.
There are actually times I wish I wouldn't have gone to Germany. I wouldn't have to deal with the jealousy, I wouldn't have lost time with my family, and I wouldn't have come back with a pneumonia that left me sick for weeks and using an inhaler. The sacrifices I made are huge and its disappointing to see how ungrateful some people are. Then I think of my dad, and another life lesson he taught me - those who really matter will always appreciate what you do for them no matter what.
I wish my dad was here - he'd be the dad wearing an Essure shirt saying that's my girl. Then I close my eyes and just think of him. I can't see him, but I know he's here.
Miss you Dad...
Its been over a month since I returned from speaking in Germany and the events of that trip are still making news. I actually came down with a horrible pneumonia and was in bed for over two weeks. I had to take three courses of antibiotics and I'm still using an inhaler, but I'm over the worst part, finally.
A reporter from Germany flew to the states and interviewed both me and Erin Brockovich for an upcoming story. That interview was unlike any other I've done since I embarked on a journey against Essure with my e-sisters. We sat in my living room with our shoes off eating pretzels. She really wanted to know more about me and what makes me tick. Its actually thoughts of that interview which have me wanting to share more about how I became the fearless one who just doesn't know how to back down from a challenge. I am who I am because of my dad.
He was the product of dirt poor farmers in Batavia, New York. Sadly, he and his siblings ended up in a children's home because his parents couldn't provide for them. As soon as he was able to leave the home, he enlisted in the military, specifically the United States Air Force where he was a Tactical Munitions Specialist. Those are fancy words to describe someone who built and dismantled bombs and designed guns. He served in Vietnam and a few other lesser known conflicts. Basically, anywhere they needed bombs put together, my dad was there. He served in the military for over 20 years and went close to home, Cheektowaga, New York, to live after he retired.
In June of 2002, my dad started complaining of headaches. A few short months later, in October, we learned after a battery of tests that the headaches were from a malignant squamous cell tumor in his brain. We were told that he had, at more, three months to live. We lost him in December, and even though we knew it was coming, it was the words he shared with him in those few short months that made the biggest impact on who I am today.
My dad made sure he taught me every life lesson he could think of and I'll never forget anything. Things like know the enemy, don't ever be afraid to stand up for what's right (all of us) even when no one wants to listen; if the doors are closed and the windows are locked, bust them down; sometimes you just have to piss people off to get them to listen; don't ever be afraid of failure; never miss an opportunity to do something for the greater good; be the one to do something that no one else can do because someone has to stand up and do it, and if you don't, no one else will; use your head, but act with your heart.
When I was prepping for Germany and when I stood on the stage, it was my dad's words in my head and all of you in my heart... Without these little lessons from my dad, I would have never been able to learn German in two weeks and give a speech in the lion's den.
Sadly, I wish my dad would have been able to prepare me for the hardest part of giving a speech that has gotten so much attention - how to deal with people who are jealous of the attention I'm suddenly getting. I don't want to be the story; the message is the story and the suffering that Essure has caused is the real story. There are even some who think I'm only in this for me and I can't express how much this actually hurts. I sacrificed so much time away from my family working with a public speaking coach and then working with a German tutor so I could give the speech in German or we wouldn't be heard.
There are actually times I wish I wouldn't have gone to Germany. I wouldn't have to deal with the jealousy, I wouldn't have lost time with my family, and I wouldn't have come back with a pneumonia that left me sick for weeks and using an inhaler. The sacrifices I made are huge and its disappointing to see how ungrateful some people are. Then I think of my dad, and another life lesson he taught me - those who really matter will always appreciate what you do for them no matter what.
I wish my dad was here - he'd be the dad wearing an Essure shirt saying that's my girl. Then I close my eyes and just think of him. I can't see him, but I know he's here.
Miss you Dad...
Saturday, May 3, 2014
Enlightening
This has been the most remarkable week of my life and I’m feeling emotionally numb. I worked long and hard on my speech for Germany and it’s amazing that I had the opportunity to do this again.
The one word which seems to sum up my experience in Germany is enlightening. I feel like I’m crashing from a very powerful emotional roller coaster. I simply can’t stop thinking about all the other women that have been injured by a Bayer product. Those ladies made the most amazing impact on me and their stories won’t leave my head or my heart. Yes, I have my own remarkable story; however, it pales in comparison to the stories of the ladies I met in Germany.
Yes, I did almost die, however, I was never actually dead. I didn’t have to have my heart restarted by paddles. Yes, I have permanent scars, but I didn’t have a stroke leaving me with brain damage, or worse. Part of me feels like a hypocrite for complaining about losing lots of blood. I feel like a whiner for complaining about my symptoms, which while bad, do not come close to what those other ladies deal with daily. I don't have to take medication for the rest of my life. My long term damage is unknown and this is one time where ignorance truly is bliss. I am constantly saying no one should walk in my shoes; however, I’d give anything to have those ladies in my shoes because I am so lucky compared to what they will have to endure for the rest of their lives.
We all have one thing is common; a Bayer product did this to us and it’s only birth control; JUST birth control. We chose the products for the same reason – we thought they were safe and effective. Bayer sold them the same load of lies that have sold to so many with their bogus studies and fuzzy math. What they did with Essure they have done with every product they have on the market. Effectiveness based on selective inclusion and exclusion; no long term studies; no safety studies. It’s a bunch of Bayer bullshit aimed at making themselves rich at the expensive of the horrific suffering on the backs of women.
This is why the name of my foundation is so significant – Women Advocating Reproductive Safety, WARS. Yes, the acronym holds true. This is our own WAR, and it’s not about one product or one group of women. It’s a GLOBAL issue affecting women from EVERY country. If we don’t take a stand now, and take a stand together, our daughters will suffer the same consequences.
We are so fortunate to have the Coalition Against Bayer Dangers as an ally. The amount of respect I gained for the work done by Philip can't be described in words. We are so fortunate to have found them and they so graciously invited us to join them at the Bayer Stockholders meeting. I will be there again next year and its my pledge to all women that we will stand as one; the product no longer matters. Its the same issue - Bayer products are dangerous and we have to put an end to their continued abuse of women.
The one word which seems to sum up my experience in Germany is enlightening. I feel like I’m crashing from a very powerful emotional roller coaster. I simply can’t stop thinking about all the other women that have been injured by a Bayer product. Those ladies made the most amazing impact on me and their stories won’t leave my head or my heart. Yes, I have my own remarkable story; however, it pales in comparison to the stories of the ladies I met in Germany.
Yes, I did almost die, however, I was never actually dead. I didn’t have to have my heart restarted by paddles. Yes, I have permanent scars, but I didn’t have a stroke leaving me with brain damage, or worse. Part of me feels like a hypocrite for complaining about losing lots of blood. I feel like a whiner for complaining about my symptoms, which while bad, do not come close to what those other ladies deal with daily. I don't have to take medication for the rest of my life. My long term damage is unknown and this is one time where ignorance truly is bliss. I am constantly saying no one should walk in my shoes; however, I’d give anything to have those ladies in my shoes because I am so lucky compared to what they will have to endure for the rest of their lives.
We all have one thing is common; a Bayer product did this to us and it’s only birth control; JUST birth control. We chose the products for the same reason – we thought they were safe and effective. Bayer sold them the same load of lies that have sold to so many with their bogus studies and fuzzy math. What they did with Essure they have done with every product they have on the market. Effectiveness based on selective inclusion and exclusion; no long term studies; no safety studies. It’s a bunch of Bayer bullshit aimed at making themselves rich at the expensive of the horrific suffering on the backs of women.
This is why the name of my foundation is so significant – Women Advocating Reproductive Safety, WARS. Yes, the acronym holds true. This is our own WAR, and it’s not about one product or one group of women. It’s a GLOBAL issue affecting women from EVERY country. If we don’t take a stand now, and take a stand together, our daughters will suffer the same consequences.
We are so fortunate to have the Coalition Against Bayer Dangers as an ally. The amount of respect I gained for the work done by Philip can't be described in words. We are so fortunate to have found them and they so graciously invited us to join them at the Bayer Stockholders meeting. I will be there again next year and its my pledge to all women that we will stand as one; the product no longer matters. Its the same issue - Bayer products are dangerous and we have to put an end to their continued abuse of women.
Wednesday, April 30, 2014
My Speech - The German Version
Hi everyone,
The English translation of this speech is all over the web. I wanted to be sure that the German version, which are the words I actually delivered was posted also. It took quite a bit of hard work in a very short amount of time to be able to learn these words. It was worth the effort!!!
Vor ein paar Jahren hatte ich ein Bayer-Gerät in mir implantiert. Ich wählte dieses Gerät, ein verhütungsmittel, weil es von der United States Food and Drug Administration zugelassen war. Dies Gerät wurde auch als sicher und effektiv beworben. Der größte Fehler meines Lebens war die Wahl dieses Gerät. Es hat mich verändert und hinterließ dauerhafte memories an den Tag, an dem ich faast starb. Die physischen und emotionalen Narben werden nie wieder verschwinden. Ich heisse Michelle Garcia und ich bin aus Miami, Florida. Ich bin ein Opfer und eine Überlebende von Essure und eine Stimme von Tausenden. Ich stehe vor Ihnen mit einer starken Botschaft. Essure ist gefährlich und Essure gehört nicht auf den Markt.
Essure ist eine Form der Geburtenkontrolle, die dazu bestimmt ist, die nicht-chirurgische Alternative zu einem Tubenligation sein. Im April zweitausend dreizehn, kündigte Bayer die Übernahme von einer Firma namens Conceptus. Während der Zeit, die sie in der Existenz waren, war Conceptus nie profitabel. Bayer hat Conceptus und Essure erworben. Sieben Studien nach weniger als sechshundert Frauen mit Essure veröffentlicht wurden. Die Daten werden auch verwendet, um die Vorrichtung Ansprüche sicher und effektiv zu unterstützen.
Das ist meine Story… Eine kaputte Essure-Spirale durchbohrte meinen Eileiter, was innere Blutungen und Hämatome brachte. Gott sei danke stoppte die Blutung in der Notaufnahme, aber ich hatte schon eine ganze Menge Blut verloren und war kurz davor eine Bluttransfusion zu benötigen. Ich könnte tot sein; ich sollte tot sein. Gibt es sehr viele Frauen mit Storyn viel schlimmer als meine. Für jede story wir wissen, gibt es Tausende mehr noch nicht gemeldet sind.
Zweitausend Elf, eine Mutter namens Angie Firmalino begann eine gruppe namens Essure Probleme mit ihren Freunden über die Auswirkungen dieses Gerät auf ihrem Körper hatte zu warnen. Ich fand die Gruppe im Mai zweitausend zwölf, als es nur dreißig Mitglieder gab. Heute gibt es weltweit, mehr als siebentausend Frauen stark, zehn Mal mehr als die Größe der klinischen Studien.
Gabriela Avina ist eine Therapeutin mit einem Master in Frauenpflege. Sie wurde in den klinischen Studien beteiligt professionell und wurde eine klinische Studie Teilnehmer im Oktober zweitausend. Zweitausendzwei sprach sie bei der United States Food and Drug Administration als klinische Versuchspatientin vor. Gabriela wurde Sprecherin für Essure und reiste durch die USA, um Essure zu bewerben. Sie ahnte nicht, dass das Gerät ihre Gesundheit langsam zerstörte.
Anfang des Jahres stellte sich Gabriella erneut der United States Food and Drug Administration vor. Während dieser Präsentation sagte sie aus, dass sie falsch lag, als sie vor zwölf Jahren das Gerät unterstützte. In ihren Worten sagte sie: „Die Leben von Frauen wurden durch ein Gerät verändert, das während klinischer Versuche nicht angemessen überwacht wurde von Ärzten, die nicht angemessen ausgebildet waren, und von einer Firma, die ihren Patientinnen nicht angemessen zuhörte.“
Wie sicher ist ihr Gerät also?: Drei Prozent der Damen in unserer Gruppe sind entweder schwanger ist oder schwanger gewesen. Zwei Pro der Schwangerschaften führten zum Tod des Kindes, während fünfzig Pro unserer Frauen Fehlgeburten hatten. Das ist ein großer differenz zu Ihrem veröffentlicht Erfolgsquote von neunundneunzig Pro. Die March of Dimes, berichtet die erwartete rate für Fehlgeburten ist zehn bis fünfzehn Pro.
Wir bereiteten eine Umfrage, damit wir genauere Informationen zu den Damen in unserer Gruppe sammeln. Die Antworten unterstützt die dringende Notwendigkeit, das Gerät sofort vom Markt genommen zu haben. Fast vierzig Pro der gemeldeten Probleme zu Essure Zusammenhang fast sofort nach der Platzierung mit zweiunddreißig Pro, dass ihre Berichterstattung Spulen sind nicht mehr richtig platziert. Nach der erfolgreichen Platzierung und Bestätigung der Okklusion, können die Spulen bewegen. Eileiterschwangerschaft, die eine erwartete Auftrittsrate von zwei Pro hat, kam in vierzehn Pro der Schwangerschaften.
Achtundvierzig Pro gaben an, sie haben drei oder mehr Fehlgeburten erlebt. Für ein effektives Gerät berichteten Fünfzehn Pro der Antwortenden, dass sie keine erfolgreiche Eileiterunterbindung hatten. Diese Fünfundachtzig Pro-Fehlerrate ist bedeutend verschieden von der Erfolgsrate, die während der klinischen Versuche beschrieben wurde.
Fast Eintausend Frauen, uber funftenn Pro unserer Mitglieder, Frauen ab zwei + zwanzig Jahren, hatten große Operationen, meistens eine Hysterektomie, um die Spiralen zu entfernen. In vielen Fällen ist eine Operation nicht aus, um alle Schäden zu reparieren. Diese Operationen dienen meistens dazu, fehlgeleitete Spiralen zu finden, die außerhalb des Eileiters gelandet sind. Essure ist vielleicht die operationsfreie Alternative einer Tuballigatur, aber es schützt einen nicht vor der Chirurgie.
Die „Glücklichen“ unter uns hatten Spiralen, die in der Gebärmutter gelandet sind. Für einige Frauen, haben docktoren Spulen von der Nähe der Leber, der Niere, Brusthöhle, Bauchhöhle und der Auskleidung der Magen entnommen. Eine Frau hatte eine Essure Spule in ihre dickdarm zu migrieren. Sie müssen eine Dickdarmresektion durch den Aufbau von Narbengewebe haben. Ihr Darm auch ihr Rektum fusioniert. Trotz dessen wird Essure immer noch beschrieben und verkauft als eine SICHERE Verhütungsmethode.
Die anderen Fünfundachtzig Pro unserer Gruppe, die die Spiralen nicht entfernen lassen konnten – sei es wegen fehlenden Geldes oder weil sie keinen Arzt finden, der sie entfernt – leiden an den gleichen Nebenwirkungen, die die anderen Frauen unserer Gruppe zur Operation gebracht haben.
Viele dieser Frauen können ihre Fragen im Zusammenhang mit einer allergischen Reaktion auf Nickel-Attribut und ein Essure Spule ist mehr als fünfzig Pro Nickel. Nickel ist ein häufiges Allergen und eine Kontraindikation wurde einbezogen, wenn das Gerät zuerst in Verkehr gebracht wurde. Die Kontraindikation wurde aus dem Etikett in zweitausend elf entfernt.. Der CEO von Conceptus erklärt den Zweck der neuen Label war, ich zitiere, "zur weiteren Stärkung unserer Wettbewerbsvorteil und Führung in der Dauerverhütungs Markt.“ In der selben formelle Erklärung sagt er, dass Conceptus diese Veränderung den Mitgliedern der OB/GYN-Gesellschaft aggressiv vermarkten wird, die unser Produkt nicht benutzen „vor allem wegen der potentiellen Nickelallergie bei kranke.“ Die Motivation für diese Änderung wurde nicht auf die Sicherheit der kranke, sondern auf finanzielle Interesse des Herstellers. Sie machten ihre Arbeit so gut mit dem aggressiven Marketing, dass Zweiundachtzig Pro der auf unsere Umfrage Antwortenden nicht über Metallallergien befragt wurden. Die Veränderung der Beschreibung brachte viele docktoren dazu zu glauben, das Nickel vollständig aus dem Produkt entfernt wurde.
Frauen leiden unter einer allergischen Reaktion leben mit ständigen Schmerzen, Reizung und Entzündung.
Frauen ohne einer Nickelallergie leiden auch intensiv mit ähnlichen Nebenwirkungen, die rauben uns unsere Gesundheit und Lebensqualität. Wir leiden mit schweren Becken-Ebene, Kopfschmerzen, Gelenkschmerzen, chronische Entzündungen, extreme Müdigkeit, schwere Blähungen, Hauterkrankungen, abnormale Blutungen und viele andere Neben Bemühungen. Die Nebenwirkungen von Essure betreffen jeden in der Familie, nicht nur die Kranke. Kinder wachsen mit einer Mutter auf, die nicht gesund ist – die ihr Kind nicht hochheben und umarmen kann. Paare können keine intimen Beziehungen haben, weil das viel zu schmerzhaft wäre. Frauen schreiben Nachrichten in unserer Gruppe Selbstmord wegen der Schmerzen, die durch Essure verursacht.. Sie sind so krank, dass totsein die bessere Alternative scheint. All das nur für ein Verhütungsmittel,
Ich verbleibe mit zwei Storyn über die Verletzungen von Essure. Die erste ist ein Baby namens Julius. Er wurde geboren, weil, wie bei so vielen, Essure versagte. Julius 'Mutter ging in vorzeitigen Wehen, wenn eine Spule Essure perforiert ihre Fruchtblase verursacht ihr Wasser zu brechen. Julius lebend geboren wurde, und seine unterentwickelte Lungen konnte ihn nicht aufrecht zu erhalten. Julius starb am Tag seiner Geburt, ist ein unschuldiges Opfer eines Geräts, das Sie sagen weiterhin sicher und wirksam.
Wir haben gelernt, über die Frauen in der letzten Story, wenn ein unerwünschtes Ereignis Bericht wurde mit dem "United States Food and Drug Administration" abgelegt. Während wir ihren Namen nicht kennen, wissen wir, dass sie jemandes Ehefrau, Mutter und Tochter sind. Sie hatte Essure und ging in die Notaufnahme klagte über Bauchschmerzen. Eine Prüfung hatte festgestellt, dass ihr Fortpflanzungssystem, speziell ihren Gebärmutterhals, Eileiter und Gebärmutter waren nekrotisch. In juristischer Sicht, waren ihre Organe Tot. Sie ging in Nierenversagen und war nicht in der Lage sich zu erholen. Ihre Todesursache wird als Nekrose und toxische Schock-Syndrom aufgeführt. Die Frage, was verursacht ihre Organe zu sterben, was zu ihrem Tod nicht auf der Grundlage eines Berichts beantwortet werden. Julius und die Frauen in dem Bericht sind tot. Werden Sie weiterhin sagen, dass dieses Gerät sicher und effektiv ist? Im Namen der siebentausend Frauen, die mir vertrauen, um ihre Stimme zu sein, und die Frauen, die wir noch zu hören, aus, bitten wir Sie, Essure vom Markt zu nehmen. Ich danke Ihnen für die Gelegenheit, bevor Sie sprechen. Bitte sie entfernen Essure aus dem Markt.
The English translation of this speech is all over the web. I wanted to be sure that the German version, which are the words I actually delivered was posted also. It took quite a bit of hard work in a very short amount of time to be able to learn these words. It was worth the effort!!!
Vor ein paar Jahren hatte ich ein Bayer-Gerät in mir implantiert. Ich wählte dieses Gerät, ein verhütungsmittel, weil es von der United States Food and Drug Administration zugelassen war. Dies Gerät wurde auch als sicher und effektiv beworben. Der größte Fehler meines Lebens war die Wahl dieses Gerät. Es hat mich verändert und hinterließ dauerhafte memories an den Tag, an dem ich faast starb. Die physischen und emotionalen Narben werden nie wieder verschwinden. Ich heisse Michelle Garcia und ich bin aus Miami, Florida. Ich bin ein Opfer und eine Überlebende von Essure und eine Stimme von Tausenden. Ich stehe vor Ihnen mit einer starken Botschaft. Essure ist gefährlich und Essure gehört nicht auf den Markt.
Essure ist eine Form der Geburtenkontrolle, die dazu bestimmt ist, die nicht-chirurgische Alternative zu einem Tubenligation sein. Im April zweitausend dreizehn, kündigte Bayer die Übernahme von einer Firma namens Conceptus. Während der Zeit, die sie in der Existenz waren, war Conceptus nie profitabel. Bayer hat Conceptus und Essure erworben. Sieben Studien nach weniger als sechshundert Frauen mit Essure veröffentlicht wurden. Die Daten werden auch verwendet, um die Vorrichtung Ansprüche sicher und effektiv zu unterstützen.
Das ist meine Story… Eine kaputte Essure-Spirale durchbohrte meinen Eileiter, was innere Blutungen und Hämatome brachte. Gott sei danke stoppte die Blutung in der Notaufnahme, aber ich hatte schon eine ganze Menge Blut verloren und war kurz davor eine Bluttransfusion zu benötigen. Ich könnte tot sein; ich sollte tot sein. Gibt es sehr viele Frauen mit Storyn viel schlimmer als meine. Für jede story wir wissen, gibt es Tausende mehr noch nicht gemeldet sind.
Zweitausend Elf, eine Mutter namens Angie Firmalino begann eine gruppe namens Essure Probleme mit ihren Freunden über die Auswirkungen dieses Gerät auf ihrem Körper hatte zu warnen. Ich fand die Gruppe im Mai zweitausend zwölf, als es nur dreißig Mitglieder gab. Heute gibt es weltweit, mehr als siebentausend Frauen stark, zehn Mal mehr als die Größe der klinischen Studien.
Gabriela Avina ist eine Therapeutin mit einem Master in Frauenpflege. Sie wurde in den klinischen Studien beteiligt professionell und wurde eine klinische Studie Teilnehmer im Oktober zweitausend. Zweitausendzwei sprach sie bei der United States Food and Drug Administration als klinische Versuchspatientin vor. Gabriela wurde Sprecherin für Essure und reiste durch die USA, um Essure zu bewerben. Sie ahnte nicht, dass das Gerät ihre Gesundheit langsam zerstörte.
Anfang des Jahres stellte sich Gabriella erneut der United States Food and Drug Administration vor. Während dieser Präsentation sagte sie aus, dass sie falsch lag, als sie vor zwölf Jahren das Gerät unterstützte. In ihren Worten sagte sie: „Die Leben von Frauen wurden durch ein Gerät verändert, das während klinischer Versuche nicht angemessen überwacht wurde von Ärzten, die nicht angemessen ausgebildet waren, und von einer Firma, die ihren Patientinnen nicht angemessen zuhörte.“
Wie sicher ist ihr Gerät also?: Drei Prozent der Damen in unserer Gruppe sind entweder schwanger ist oder schwanger gewesen. Zwei Pro der Schwangerschaften führten zum Tod des Kindes, während fünfzig Pro unserer Frauen Fehlgeburten hatten. Das ist ein großer differenz zu Ihrem veröffentlicht Erfolgsquote von neunundneunzig Pro. Die March of Dimes, berichtet die erwartete rate für Fehlgeburten ist zehn bis fünfzehn Pro.
Wir bereiteten eine Umfrage, damit wir genauere Informationen zu den Damen in unserer Gruppe sammeln. Die Antworten unterstützt die dringende Notwendigkeit, das Gerät sofort vom Markt genommen zu haben. Fast vierzig Pro der gemeldeten Probleme zu Essure Zusammenhang fast sofort nach der Platzierung mit zweiunddreißig Pro, dass ihre Berichterstattung Spulen sind nicht mehr richtig platziert. Nach der erfolgreichen Platzierung und Bestätigung der Okklusion, können die Spulen bewegen. Eileiterschwangerschaft, die eine erwartete Auftrittsrate von zwei Pro hat, kam in vierzehn Pro der Schwangerschaften.
Achtundvierzig Pro gaben an, sie haben drei oder mehr Fehlgeburten erlebt. Für ein effektives Gerät berichteten Fünfzehn Pro der Antwortenden, dass sie keine erfolgreiche Eileiterunterbindung hatten. Diese Fünfundachtzig Pro-Fehlerrate ist bedeutend verschieden von der Erfolgsrate, die während der klinischen Versuche beschrieben wurde.
Fast Eintausend Frauen, uber funftenn Pro unserer Mitglieder, Frauen ab zwei + zwanzig Jahren, hatten große Operationen, meistens eine Hysterektomie, um die Spiralen zu entfernen. In vielen Fällen ist eine Operation nicht aus, um alle Schäden zu reparieren. Diese Operationen dienen meistens dazu, fehlgeleitete Spiralen zu finden, die außerhalb des Eileiters gelandet sind. Essure ist vielleicht die operationsfreie Alternative einer Tuballigatur, aber es schützt einen nicht vor der Chirurgie.
Die „Glücklichen“ unter uns hatten Spiralen, die in der Gebärmutter gelandet sind. Für einige Frauen, haben docktoren Spulen von der Nähe der Leber, der Niere, Brusthöhle, Bauchhöhle und der Auskleidung der Magen entnommen. Eine Frau hatte eine Essure Spule in ihre dickdarm zu migrieren. Sie müssen eine Dickdarmresektion durch den Aufbau von Narbengewebe haben. Ihr Darm auch ihr Rektum fusioniert. Trotz dessen wird Essure immer noch beschrieben und verkauft als eine SICHERE Verhütungsmethode.
Die anderen Fünfundachtzig Pro unserer Gruppe, die die Spiralen nicht entfernen lassen konnten – sei es wegen fehlenden Geldes oder weil sie keinen Arzt finden, der sie entfernt – leiden an den gleichen Nebenwirkungen, die die anderen Frauen unserer Gruppe zur Operation gebracht haben.
Viele dieser Frauen können ihre Fragen im Zusammenhang mit einer allergischen Reaktion auf Nickel-Attribut und ein Essure Spule ist mehr als fünfzig Pro Nickel. Nickel ist ein häufiges Allergen und eine Kontraindikation wurde einbezogen, wenn das Gerät zuerst in Verkehr gebracht wurde. Die Kontraindikation wurde aus dem Etikett in zweitausend elf entfernt.. Der CEO von Conceptus erklärt den Zweck der neuen Label war, ich zitiere, "zur weiteren Stärkung unserer Wettbewerbsvorteil und Führung in der Dauerverhütungs Markt.“ In der selben formelle Erklärung sagt er, dass Conceptus diese Veränderung den Mitgliedern der OB/GYN-Gesellschaft aggressiv vermarkten wird, die unser Produkt nicht benutzen „vor allem wegen der potentiellen Nickelallergie bei kranke.“ Die Motivation für diese Änderung wurde nicht auf die Sicherheit der kranke, sondern auf finanzielle Interesse des Herstellers. Sie machten ihre Arbeit so gut mit dem aggressiven Marketing, dass Zweiundachtzig Pro der auf unsere Umfrage Antwortenden nicht über Metallallergien befragt wurden. Die Veränderung der Beschreibung brachte viele docktoren dazu zu glauben, das Nickel vollständig aus dem Produkt entfernt wurde.
Frauen leiden unter einer allergischen Reaktion leben mit ständigen Schmerzen, Reizung und Entzündung.
Frauen ohne einer Nickelallergie leiden auch intensiv mit ähnlichen Nebenwirkungen, die rauben uns unsere Gesundheit und Lebensqualität. Wir leiden mit schweren Becken-Ebene, Kopfschmerzen, Gelenkschmerzen, chronische Entzündungen, extreme Müdigkeit, schwere Blähungen, Hauterkrankungen, abnormale Blutungen und viele andere Neben Bemühungen. Die Nebenwirkungen von Essure betreffen jeden in der Familie, nicht nur die Kranke. Kinder wachsen mit einer Mutter auf, die nicht gesund ist – die ihr Kind nicht hochheben und umarmen kann. Paare können keine intimen Beziehungen haben, weil das viel zu schmerzhaft wäre. Frauen schreiben Nachrichten in unserer Gruppe Selbstmord wegen der Schmerzen, die durch Essure verursacht.. Sie sind so krank, dass totsein die bessere Alternative scheint. All das nur für ein Verhütungsmittel,
Ich verbleibe mit zwei Storyn über die Verletzungen von Essure. Die erste ist ein Baby namens Julius. Er wurde geboren, weil, wie bei so vielen, Essure versagte. Julius 'Mutter ging in vorzeitigen Wehen, wenn eine Spule Essure perforiert ihre Fruchtblase verursacht ihr Wasser zu brechen. Julius lebend geboren wurde, und seine unterentwickelte Lungen konnte ihn nicht aufrecht zu erhalten. Julius starb am Tag seiner Geburt, ist ein unschuldiges Opfer eines Geräts, das Sie sagen weiterhin sicher und wirksam.
Wir haben gelernt, über die Frauen in der letzten Story, wenn ein unerwünschtes Ereignis Bericht wurde mit dem "United States Food and Drug Administration" abgelegt. Während wir ihren Namen nicht kennen, wissen wir, dass sie jemandes Ehefrau, Mutter und Tochter sind. Sie hatte Essure und ging in die Notaufnahme klagte über Bauchschmerzen. Eine Prüfung hatte festgestellt, dass ihr Fortpflanzungssystem, speziell ihren Gebärmutterhals, Eileiter und Gebärmutter waren nekrotisch. In juristischer Sicht, waren ihre Organe Tot. Sie ging in Nierenversagen und war nicht in der Lage sich zu erholen. Ihre Todesursache wird als Nekrose und toxische Schock-Syndrom aufgeführt. Die Frage, was verursacht ihre Organe zu sterben, was zu ihrem Tod nicht auf der Grundlage eines Berichts beantwortet werden. Julius und die Frauen in dem Bericht sind tot. Werden Sie weiterhin sagen, dass dieses Gerät sicher und effektiv ist? Im Namen der siebentausend Frauen, die mir vertrauen, um ihre Stimme zu sein, und die Frauen, die wir noch zu hören, aus, bitten wir Sie, Essure vom Markt zu nehmen. Ich danke Ihnen für die Gelegenheit, bevor Sie sprechen. Bitte sie entfernen Essure aus dem Markt.
Tuesday, April 29, 2014
Bayer Speech - English Version
Good morning, I’ve prepared something I’d like to read to you. I’ll first speak in English, and then I’m prepared to give them same statement in German if necessary. I have also prepared some questions for the members of the Board.
A few years ago, I had a Bayer device implanted inside me. I chose this device, a birth control device, because it was approved by the United States Food and Drug Administration. This was device was also advertised as safe and effective. The biggest mistake of my life was choosing this device. It would change me, leaving me with permanent reminders of the day I almost died. The physical and emotional scars will never go away.
My name is Michelle Garcia and I live in Miami, Florida. I am an Essure victim, an Essure survivor and a voice to thousands. I stand before you with a simple, yet powerful message. Essure is dangerous and Essure does not belong on the market.
Essure is a form of birth control which is intended to be the non-surgical alternative to a tubal ligation. In April of 2013, Bayer announced the acquisition of a company called Conceptus. During the time they were in existence, Conceptus was never profitable. When Bayer acquired Conceptus, you also acquired Essure. Seven studies following less than six hundred women with Essure were published. The data from these studies was presented when Essure was approved for use in the United States. The same data is also used to support claims the device is safe and effective.
My story goes like this . . . A broken Essure coil pierced my fallopian tube, resulting in internal bleeding and hemorrhaging. Fortunately, while in the emergency room, the bleeding stopped but not before I lost a significant amount of blood and coming close to needing a blood transfusion. I could be dead; I should be dead. As terrified as I was and as frightening as my experience is, there are countless women with stories far worse than mine. For every story we do know, there are thousands more still unreported.
In 2011, a mom named Angie Firmalino, started a group called Essure Problems to warn her friends about the effects this device had on her body. I found the group in May of 2012 when there were only 30 members. Today, worldwide, we are more than 7,000 women strong, 10 times more than the size of your studies.
Gabriela Avina is a health care professional with a Master’s degree in Women’s Health Nursing. She was involved in the clinical trials professionally and became a clinical trial participant in October of 2000. In 2002, she presented to the United States Food and Drug Administration as a clinical trial patient. Gabriela went on to become a spokesperson for Essure, and she toured the United States promoting Essure. Little did she know, the device was slowly destroying her health.
Earlier this year, Gabriella made a second presentation to the United States Food and Drug Administration. During this presentation, she stated that she was wrong when she supported this device 12 years ago. In her own words, she said, “Lives of women have been changed by a device that was not adequately monitored during clinical trials, by physicians who were not adequately trained and by a company that has not adequately listened to their patients.”
So how safe and effective is your device? 3% of the ladies in our group is either currently pregnant or has been pregnant. 2% of the pregnancies ended in death of the child with 55% of our ladies suffering miscarriages. That is a big difference from your published success rate of 99%. The March of Dimes reports the expected rate for miscarriages is ten to fifteen percent.
We prepared a survey so we could collect more specific information from the ladies in our group. The responses support the urgent need to have this device immediately removed from the market. Almost 40% reported issues related to Essure almost immediately after placement with 32% reporting that their coils are no longer properly placed. After successful placement and confirmation of occlusion, the coils may move.
Ectopic pregnancy, which has an expected occurrence rate of 2%, occurred in 14% of our pregnancies. 48% indicated they have experienced three or more miscarriages. For a device that’s effective, 15% of the respondents reported they did not achieve successful tubal occlusion. That 85% failure rate is a significant difference from the success rate reported during the clinical trials.
Almost 1,000 women, over 16% of our membership, women as young as 22 years old, have had major surgeries, usually a hysterectomy to remove the coils. In many instances, one surgery isn’t enough to repair all the damage. Many have endured multiple surgical procedures costing significant amounts of money. These multiple surgeries are usually to find errant coils which have ended up outside the fallopian tube. Essure may be the non-surgical alternative to a tubal ligation, but it is NOT going to keep someone out of the operating room.
The “lucky” ladies have coils expel into their uterus. For some women, doctors have retrieved coils from the vicinity of their liver, kidney, chest cavity, abdominal cavity and the lining of their stomach. One woman had an Essure coil migrate into her colon. She was required to have a colon resection due to the buildup of scar tissue. Her intestines also fused to her rectum. Despite this, Essure continues to be labeled and marketed as a form of birth control that is SAFE.
For the 84% of our group who have not been able to get the coils removed due to a lack of financial resources or the inability to find a surgeon willing to remove them, they suffer from the same debilitating side effects which led the other ladies in our group to the operating room.
Many of these women can attribute their issues to an allergic reaction to nickel, and an Essure coil is over 50% nickel. Nickel is a common allergen and a contraindication was included when the device was first marketed. The contraindication was removed from the label in 2011. The CEO of Conceptus explained the purpose of the new label was to further strengthen our competitive advantage and leadership in the permanent birth control market. In the same press release, he states that Conceptus will be aggressively marketing this change to the members of the OB/GYN community who won’t use our product “primarily because of potential nickel allergy in patients.” The motivation for this change was not based on patient safety but on the manufacturer’s financial interest. They did such a great job with their aggressive marketing that 82% of the respondents to our survey were not asked about any metal sensitivities. And the change in label led some doctors to believe that nickel had been completely removed from the product.
Women suffering from an allergic reaction live with constant pain, irritation and inflammation.
Women without a nickel allergy are also suffering with similar intense side effects which rob us of our health and a quality of life. We suffer with severe pelvic plain, headaches, joint pain and deterioration, chronic inflammation, extreme fatigue, severe bloating, skin conditions, irregular bleeding and many other side efforts. The side effects of Essure affect everyone in a family, not just the patient. Children grow up with a mom who is not healthy — who can’t lift and hug her child. Couples are robbed of their ability to have an intimate relationship because the act of making love is far too painful. Women post messages in our group contemplating suicide because of the pain caused by Essure. They are just so sick that being dead just seems like a better alternative. All of this for birth control; just birth control.
I leave you with two final stories. The first is a baby named Julius. He was conceived because, as with so many, Essure failed. Julius’ mom went into premature labor when an Essure coil perforated her amniotic sack causing her water to break. Julius was born alive, and his under-developed lungs couldn’t sustain him. Julius died on the day he was born, an innocent victim of a device you continue to say is safe and effective.
We learned about the women in the last story when an adverse event report was filed with the "United States Food and Drug Administration". While we don’t know her name, we know she was someone’s wife, mother and daughter. She had Essure and went to the emergency room complaining of abdominal pain. An exam found that her reproductive system, specifically her cervix, fallopian tubes and uterus were necrotic. In layman’s term, her organs were dead. She went into renal failure and did not recover. Her cause of death is listed as necrosis and toxic shock syndrome. The question of what caused her organs to die resulting in her death can’t be answered based on a report; however, it’s a coincidence that can’t be ignored.
Julius and the women in report number are dead. Will you still say this device is safe and effective?
On behalf of the 7,000 women who trust me to be their voice, and the women we have yet to hear from, we ask you, pull Essure from the market. I thank you for the opportunity to speak before you. Please do the right thing. Remove Essure from the market.
A few years ago, I had a Bayer device implanted inside me. I chose this device, a birth control device, because it was approved by the United States Food and Drug Administration. This was device was also advertised as safe and effective. The biggest mistake of my life was choosing this device. It would change me, leaving me with permanent reminders of the day I almost died. The physical and emotional scars will never go away.
My name is Michelle Garcia and I live in Miami, Florida. I am an Essure victim, an Essure survivor and a voice to thousands. I stand before you with a simple, yet powerful message. Essure is dangerous and Essure does not belong on the market.
Essure is a form of birth control which is intended to be the non-surgical alternative to a tubal ligation. In April of 2013, Bayer announced the acquisition of a company called Conceptus. During the time they were in existence, Conceptus was never profitable. When Bayer acquired Conceptus, you also acquired Essure. Seven studies following less than six hundred women with Essure were published. The data from these studies was presented when Essure was approved for use in the United States. The same data is also used to support claims the device is safe and effective.
My story goes like this . . . A broken Essure coil pierced my fallopian tube, resulting in internal bleeding and hemorrhaging. Fortunately, while in the emergency room, the bleeding stopped but not before I lost a significant amount of blood and coming close to needing a blood transfusion. I could be dead; I should be dead. As terrified as I was and as frightening as my experience is, there are countless women with stories far worse than mine. For every story we do know, there are thousands more still unreported.
In 2011, a mom named Angie Firmalino, started a group called Essure Problems to warn her friends about the effects this device had on her body. I found the group in May of 2012 when there were only 30 members. Today, worldwide, we are more than 7,000 women strong, 10 times more than the size of your studies.
Gabriela Avina is a health care professional with a Master’s degree in Women’s Health Nursing. She was involved in the clinical trials professionally and became a clinical trial participant in October of 2000. In 2002, she presented to the United States Food and Drug Administration as a clinical trial patient. Gabriela went on to become a spokesperson for Essure, and she toured the United States promoting Essure. Little did she know, the device was slowly destroying her health.
Earlier this year, Gabriella made a second presentation to the United States Food and Drug Administration. During this presentation, she stated that she was wrong when she supported this device 12 years ago. In her own words, she said, “Lives of women have been changed by a device that was not adequately monitored during clinical trials, by physicians who were not adequately trained and by a company that has not adequately listened to their patients.”
So how safe and effective is your device? 3% of the ladies in our group is either currently pregnant or has been pregnant. 2% of the pregnancies ended in death of the child with 55% of our ladies suffering miscarriages. That is a big difference from your published success rate of 99%. The March of Dimes reports the expected rate for miscarriages is ten to fifteen percent.
We prepared a survey so we could collect more specific information from the ladies in our group. The responses support the urgent need to have this device immediately removed from the market. Almost 40% reported issues related to Essure almost immediately after placement with 32% reporting that their coils are no longer properly placed. After successful placement and confirmation of occlusion, the coils may move.
Ectopic pregnancy, which has an expected occurrence rate of 2%, occurred in 14% of our pregnancies. 48% indicated they have experienced three or more miscarriages. For a device that’s effective, 15% of the respondents reported they did not achieve successful tubal occlusion. That 85% failure rate is a significant difference from the success rate reported during the clinical trials.
Almost 1,000 women, over 16% of our membership, women as young as 22 years old, have had major surgeries, usually a hysterectomy to remove the coils. In many instances, one surgery isn’t enough to repair all the damage. Many have endured multiple surgical procedures costing significant amounts of money. These multiple surgeries are usually to find errant coils which have ended up outside the fallopian tube. Essure may be the non-surgical alternative to a tubal ligation, but it is NOT going to keep someone out of the operating room.
The “lucky” ladies have coils expel into their uterus. For some women, doctors have retrieved coils from the vicinity of their liver, kidney, chest cavity, abdominal cavity and the lining of their stomach. One woman had an Essure coil migrate into her colon. She was required to have a colon resection due to the buildup of scar tissue. Her intestines also fused to her rectum. Despite this, Essure continues to be labeled and marketed as a form of birth control that is SAFE.
For the 84% of our group who have not been able to get the coils removed due to a lack of financial resources or the inability to find a surgeon willing to remove them, they suffer from the same debilitating side effects which led the other ladies in our group to the operating room.
Many of these women can attribute their issues to an allergic reaction to nickel, and an Essure coil is over 50% nickel. Nickel is a common allergen and a contraindication was included when the device was first marketed. The contraindication was removed from the label in 2011. The CEO of Conceptus explained the purpose of the new label was to further strengthen our competitive advantage and leadership in the permanent birth control market. In the same press release, he states that Conceptus will be aggressively marketing this change to the members of the OB/GYN community who won’t use our product “primarily because of potential nickel allergy in patients.” The motivation for this change was not based on patient safety but on the manufacturer’s financial interest. They did such a great job with their aggressive marketing that 82% of the respondents to our survey were not asked about any metal sensitivities. And the change in label led some doctors to believe that nickel had been completely removed from the product.
Women suffering from an allergic reaction live with constant pain, irritation and inflammation.
Women without a nickel allergy are also suffering with similar intense side effects which rob us of our health and a quality of life. We suffer with severe pelvic plain, headaches, joint pain and deterioration, chronic inflammation, extreme fatigue, severe bloating, skin conditions, irregular bleeding and many other side efforts. The side effects of Essure affect everyone in a family, not just the patient. Children grow up with a mom who is not healthy — who can’t lift and hug her child. Couples are robbed of their ability to have an intimate relationship because the act of making love is far too painful. Women post messages in our group contemplating suicide because of the pain caused by Essure. They are just so sick that being dead just seems like a better alternative. All of this for birth control; just birth control.
I leave you with two final stories. The first is a baby named Julius. He was conceived because, as with so many, Essure failed. Julius’ mom went into premature labor when an Essure coil perforated her amniotic sack causing her water to break. Julius was born alive, and his under-developed lungs couldn’t sustain him. Julius died on the day he was born, an innocent victim of a device you continue to say is safe and effective.
We learned about the women in the last story when an adverse event report was filed with the "United States Food and Drug Administration". While we don’t know her name, we know she was someone’s wife, mother and daughter. She had Essure and went to the emergency room complaining of abdominal pain. An exam found that her reproductive system, specifically her cervix, fallopian tubes and uterus were necrotic. In layman’s term, her organs were dead. She went into renal failure and did not recover. Her cause of death is listed as necrosis and toxic shock syndrome. The question of what caused her organs to die resulting in her death can’t be answered based on a report; however, it’s a coincidence that can’t be ignored.
Julius and the women in report number are dead. Will you still say this device is safe and effective?
On behalf of the 7,000 women who trust me to be their voice, and the women we have yet to hear from, we ask you, pull Essure from the market. I thank you for the opportunity to speak before you. Please do the right thing. Remove Essure from the market.
Bayer's Love is Like Bad Medicine
Today was the big day; I read my speech at the Bayer Annual Stockholders meeting. And it was one heck of a day!
Many of you know me and how humble I am; you also know how fearless I am. I kid you not when I say I pale in comparison to some of the ladies I met today who are also Bayer Survivors. I can't seem to forget them.
The one who won't leave my thoughts is Felicity. At the age of 26, she was dead for 20 minutes because of a cardiac issue brought on by a Bayer product. As we were speaking, it was truly like looking into a mirror. Here is someone else, who like me, chose a product for only birth control, just birth control. She didn't buy a life time of health issues, or complications or even wake up one day saying I'm going to fight. She is just like me- right down to the fact she can look at a calendar and know that there is a day on that calendar that should be on her grave stone. She said it's changed me forever, and I can completely empathize with every word she said. She, like so many I met today, is one of us.
We aren't the victims anymore; we are the survivors; the thrivers and the fighters. We weren't born for this, but this became our reality.
As many of you know, two weeks ago, I learned I had to speak in German. Yes, two weeks ago. I came prepared to speak in English and German. I sat in the audience and watched at Bayer had their security staff escort a women from the room who wasn't able to give her remarks in German. I was stunned. I guess Bayer has not heard of the 'global economy.' Anyway, I openned my speech with a statement in English, and the rest was in German. I know they were not expecting a blonde from Miami with a Latin last name to speak German, but I did and I'll do it again.
Many of you know me and how humble I am; you also know how fearless I am. I kid you not when I say I pale in comparison to some of the ladies I met today who are also Bayer Survivors. I can't seem to forget them.
The one who won't leave my thoughts is Felicity. At the age of 26, she was dead for 20 minutes because of a cardiac issue brought on by a Bayer product. As we were speaking, it was truly like looking into a mirror. Here is someone else, who like me, chose a product for only birth control, just birth control. She didn't buy a life time of health issues, or complications or even wake up one day saying I'm going to fight. She is just like me- right down to the fact she can look at a calendar and know that there is a day on that calendar that should be on her grave stone. She said it's changed me forever, and I can completely empathize with every word she said. She, like so many I met today, is one of us.
We aren't the victims anymore; we are the survivors; the thrivers and the fighters. We weren't born for this, but this became our reality.
As many of you know, two weeks ago, I learned I had to speak in German. Yes, two weeks ago. I came prepared to speak in English and German. I sat in the audience and watched at Bayer had their security staff escort a women from the room who wasn't able to give her remarks in German. I was stunned. I guess Bayer has not heard of the 'global economy.' Anyway, I openned my speech with a statement in English, and the rest was in German. I know they were not expecting a blonde from Miami with a Latin last name to speak German, but I did and I'll do it again.
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