Wednesday, September 25, 2013

Labor with Essure - Life Altering


As many of you know, the life of a baby boy was lost when his mom suffered complications during labor. Sadly, this isn't the first time a mom has suffered complications during labor. This entry tells the story of the day Luke Schmidt was born. It’s the day his dad, Jon, almost became a widow and his wife, Lora, almost became a statistic. This story is testament to dangers a mom with Essure experiences during pregnancy and labor.

September 1, 2011 is a day that Jon and Lora will never forget. Luke came into the world, and he's a miracle baby. His mom, Lora, had been implanted with Essure and the odds of pregnancy are incredibly slim if you believe the numbers published by Conceptus/Bayer. Essure failed Lora and she was expecting her next child.

Labor was not easy for Lora, but its post delivery which left Lora in the fight of her life. After the delivery, Lora was bleeding internally and the doctors we're struggling to locate the source of the bleeding. For the next 8 hours, starting at 2pm, several attempts were made to rectify the crisis including at emergency DNC.

At around 10:30pm, the doctors assured Jon that Lora would be fine and they resolved the issues that caused the bleeding. Jon had heard that many times, and he was praying this was finally true. It seemed to be that was the case because the doctors went home, Lora's parents left and Jon sent texts that everything was finally okay.

Baby Luke hadn't been named yet, and he was in the nursery waiting to be held by both Mom and Dad so they could decide on the right name for the miracle baby. Lora had basically been through hell and was very weak. She had bled internally for over 8 hours, and that much blood loss takes an extreme toll on someone. Jon is doing the best he can do for his wife, when in a moment like this, all he can really do is be there.

It’s now about 11:15pm, and the crisis is not over despite having been told this multiple times by multiple doctors. Lora suddenly passes a blood clot which, in Jon's estimate, is the size of a small baby. Her blood pressure crashes and reads at dangerously low 28/51. Lora starts the first of three blood transfusions and emergency surgeons are called in from home. What was once a quite place with only Jon and Lora has erupted into complete chaos. There are at least 10 to 12 nurses in the room as well as the anesthesiologist who is barking orders after bursting into the room. It’s the actions of this one person which Jon credits with saving the life of Lora. The bed is titled at a severe angle with her feet in the air and head to the floor. An IV is set in her neck and the transfusions are being fed into her from this vein which is very high so the blood would flow faster.

Jon took a moment to survey Lora and the nurses in the room. Four are visibly shaking and shedding tears. It was at that moment when the trauma of the day fully hit him. Jon is now shedding tears while in complete shock. Lora is suddenly on the move, being wheeled into surgery again. It’s not the first time she's been in that part of the hospital. As they are running, Lora calls out to Jon, "Mister" she says which is her pet name for him. She is saying this while drifting in and out of consciousness. They are now running full speed to the elevator with a full team of medical professionals. The very short elevator ride feels like an eternity. Jon is holding Lora's hand tight and she says "It hurts Mr., I can't do this anymore".

Finally out of the elevator, they are off at full sprint again to the OR. The IV cart gets caught in the floor board and falls to the floor causing Lora's arm to get pulled back as the bed is still moving. She screams in pain and the doctor lifts it back up and the sprint starts again. "I'm sorry Baby it won't happen again" Jon says to Laura. The IV then hits the top of the next door jam and falls again which results in more screams from Lora. Jon lets out a curse and to the doctor and takes control of the IV cart himself, all the while, he's NOT letting go of Lora's hand.

They reach the surgery doors and Lora asks "Mister is the baby OK?" "Yes, pretty girl, he is fine. He is with the nurses." She then asks Jon if she did okay. He tells her he's proud of her and she did great. "Why is this happening Mister?" Lora wants to know. Jon says that he doesn't. Lora then asks if she's going to be okay. Jon says yes, reassuring her that they know what it is this time. The truth is they still don't know what it is and he has no idea if Lora is going to be okay.

"You're going to be fine, I love you so much baby" are the last words Jon is able to say before his journey with the gurney comes to an end. He can't follow Lora the rest of the way and he stands there watching them continue to run with Lora. Tears are streaming down his face and he's surrounded by dead silence. It's now about 1:30am and he's been up for almost 36 hours with no food for the past 24 hours. He's not sure how he's functioning, and he's certainly not able to think straight. The fear of Lora not making it hits him hard in the eerily cold and silent hallway. All he can think about are his last words may have been a lie. He truly doesn't know if she'll be okay. He's alone in the waiting room when he notices a light shining through the small single stained glass church window which is in the chapel near the lobby. Jon is now sobbing and he prays.

"Dear God, I know I don't do this very often. I'm sorry that I only talk to you when I want something. But I really need your help right now." Jon drops to his knees as he continues to pray. "I promise I'll be a better person. I'll quit smoking. If this is because I didn't really want another baby, I'm Sorry. Please don't punish her for what I have done. I can't do this without her. Please God, I'll do anything."

A door opens and he hopes it’s someone with news about Lora. Is she OK? Is she alright now? It’s the janitor, who slowly walks past him without making any eye contact. It’s now 2:30 am and he realizes the last communication with family was "everything is fine". He calls her parents and they don't answer. Call. No answer. Pray. Cry. Call again. Cry some more. More prayers. Where is the un-named baby? Is he ok? More tears. Pray again? He then wonders "am I going to get in trouble for ignoring the baby?" Call again, still not answer. More praying, more crying. He then starts pacing and calls his mom. He manages to explain the events of the last few hours through intense sobs and she's on her way.

Finally, the anesthesiologist comes out. "Mr. Schmidt," he says, "We found the abdominal tear. I assure you she will be fine." Jon has heard this so many times that he tells the doctor that he doesn't believe him. He said "I guarantee you she is fine now" and, thankfully, it was finally true. Lora was in ICU in and medically induced coma and she really did make a full recovery. The tear was most likely caused by an Essure coil.

Baby Luke was named a few days later and he is the most precious gift. His birthday will always be full of very powerful emotions and memories. It’s one of the best and one of the worst days of Jon's life.

Jon and Lora so graciously share their story in hopes that others will be aware of what could happen.

Sunday, September 22, 2013

Conflict of Interest


In another one of my naive moments about the 'system', I thought those who approved the devices were independent of the manufacturer, and those who oversaw the studies were independent, and those who had oversight at the FDA were also independent. On paper, it seems like it would work, except is doesn't exist on paper. It doesn't exist at all. I was completely wrong and so are countless others.

I've spent several months in my battle against Essure, and the FDA. During this time, I've looked at countless documents, many of them found by Krystal Donahue, who is one of the administrators of the Essure Problems Facebook Group. We've seen the names of so many doctors, hospitals, clinics - they are starting to look the same and for a while, I began to think I was reading the same documents. Then the light clicked - it’s not the same documents, it’s the same people or different people from the same hospital over and over. What I thought was independent isn't even close.

Let's start with the members of the FDA's OB/GYN Devices Panel. These are the current members:

Dr. Thommaso Falcone
Professor and Chairman of Obstetrics & Gynecology
Cleveland Clinic Foundation
Cleveland, OH

Dr. Ann J. Davis
Dartmouth Medical School
Hanover, NH

Dr. Frank W. Ling
Obstetrics and Gynecology
Women’s Health Specialists, PLLC
Germantown, TN

Dr. Paula J. Hillard
Professor and Chief Gynecologic Specialties
Stanford Univ. School of Medicine
Dept. of Obstetrics and Gynecology
Stanford, CA

Lisa M. Maldonado, MPH
Expertise: Reproductive Health Care
Executive Director
Reproductive Health Access Project
New York, NY

Dr. Lisa E. Moore
Associate Professor
University of New Mexico
Dept of OB/GYN; Div. of Maternal Fetal Medicine
Albuquerque, NM

Conceptus has its own Advisory Board. Members of the Conceptus advisory committee are paid consulting fees for their services and those with the title of Director, are REALLY paid. The list of these physicians is below:

Dr. Linda Bradley
Cleveland Clinic Foundation
Cleveland, OH

Andrew Brill MD
Conceptus Director
Sutter Health / Sutter Pacific Medical Foundation
San Francisco, CA

Mark Levie MD
Conceptus Director
Montefiore Centennial Wmns Ctr
New York, NY

Viviane Connor MD
Cleveland Clinic Foundation
Weston and West Palm Beach, Florida

Malcolm Munro
Director of Gynecologic Services,
Served at Study Chair for Stop - precursor to Essure
Los Angeles Medical Center at Kaiser Permanente,
Los Angeles, CA

Robert Zurawin
Baylor College of Medicine
Obstetrics & Gynecology
Houston, Texas

I hope you noticed what jumps out at me - Cleveland Clinic. It’s really interesting that doctors from Cleveland Clinic sit on the OB/GYN Advisory Board of the FDA and are also members of the Conceptus advisory panel. I smell a RAT. In my FOIA request to the FDA, I've asked for all emails between Conceptus, their advisory board, and members of the FDA advisory board. My FOIA was submitted in March of 2013, and I'm still waiting...Wonder why?

Dear Dr. Linda Bradley, your boss at Cleveland Clinic sits on the same FDA panel that provides "oversight" to medical devices, including Essure. You are member of the Conceptus advisory board. Interesting, very interesting. There is more to why I'm calling out Dr. Bradly. She was one of the doctors who participated in the clinic trials. She was PAID by Conceptus to perform the trials, and these patients were implanted at Cleveland Clinic's hospital, which means the hospital got paid also. Did I mention I smell a rat? We have a young lady in our Facebook group who was a study patient. She was implanted by Dr. Bradley herself and she started having issues during the study. Instead of being helped, she was dismissed from the study. Dr. Bradley will not communicate at any level with her formal patient. She won't return phone calls, emails and is even making it difficult to get medical records.

Now, let’s talk about dear Dr. Mark Levie, who is also a Director at Conceptus and a member of their advisory board. He is a practicing physician in New York City who continues to implant patients with the device. Upon being appointed as Director, he was compensated with the equivalent of $300,000.00 in Conceptus stock. The total numbers of shares is determined by the fair market value at the time of his appointment. After 6 months of service, he received an additional $112,000.00 in stock. Following each annual shareholders meeting, he receives an additional $28,000.00 in stock. There are additional payouts awarded for serving as chair to audit committees or compensation oversight committees. These payouts are $17,500 and $10,500 respectively and all paid in stock. These compensation guidelines apply to any person who is named as an independent director as of January, 2008.

Being paid in stock gives those in this position personal motivation to ensure the stock performs well so they will make more money when they sell. In January, 2008, the stock was selling for approx. $15.00 per share. For a $300,000 award, the person received approximately 20,000 shares. The final price of the stock when Bayer bought Conceptus was $31.02 - the value had doubled. That $300,000.00 award is now worth of $600,000. And you think I'm still going to believe the doctors are neutral or independent? ABSOLUTELY NOT... They are motivated by dollar signs, and in the case of Dr. Mark Levie, we've caught you red handed and I hope to be a fly on the wall when you are thrown under the bus. Forget that, I want to drive the bus, and my e-sisters will be my passengers.

Now, let’s talk studies - there have been seven formal studies on Essure, only 7. Each and every one has been paid for by Conceptus and oversight is provided by a medical board member. There has never been a study which is independent. The numbers from these studies are what the FDA continues to site when responding to us about the safety of the device. These numbers are ALWAYS going to say the device its safe. The doctors have a vested financial interest in making the device look safe. They dismissed one person from a study, and it you've done it once, you've done it before and you'll do it again.

Did I mention I smell a rat?

Friday, September 20, 2013

Julius Alexander Montgomery - May You Rest in Peace

God of power and might,

You proved powerless to save Baby Julius. You created him in his mother's womb, formed in the image and likeness of You. Indeed, Baby Julius is Your beloved child, with whom You are well pleased, too beloved; it seems to leave here with us.

Please guard him and comfort those who mourn his loss, that they may feel Your loving embrace in their sorrow, now and always. God of hope, let the light of Your love shine in this place as Julius joins You, now and forever. Amen.

In the early morning hours of September 18th, my e-sister Latisha was woken up from a deep slumber to find her water had broken and she was in pre-mature later. She was expecting a baby boy, a miracle baby, who wasn't supposed to be here, yet, he was growing inside her. Essure failed and a baby was conceived. Shock turned to joy as the baby grew inside of her. It was to be the first child of her husband.

Sadly, that little life is now gone. Julius took his first breath, his only breath and passed away. The premature labor was the result of an Essure coil perforating the amniotic sac causing her water to break. Essure has claimed his first victim. He was born, he was alive, and now, he's a memory and an inspiration. His mom, Latisha, the courage of bravery despite feeling pain that words can't describe. His Dad, Tino, lost his first child. His sister, Lashonda, will never get to be the big sister to her baby brother.

Just a few weeks ago, she posted about an ER visit where the technician commented about the metal coils inside of her. She said 'that’s my birth control' which left the technician with a look of shock on his face. Kind words of support and encouragement were sent to so many by Latisha. She now needs words of support like those she offered to so many.

That moment when Latisha saw her baby boy drift off to permanent slumber was one of those 'Life Altering' moments. She has joined the ranks of John and Reve Walsh, Nancy G. Brinker, Beckie Brown and Claudine and Don Ryce. In an act that can only be described as profoundly brave, Latisha and her husband announced they are starting a foundation, The Julius Montgomery Foundation.

A mother and a father are turning their pain into a promise of hope, hope for others suffering with Essure and hope that no one endures the pain from the loss of a child that they now know.

Condolences for the loss of Baby Julius can be sent to the address below:
Tino and Latisha S. Montgomery
12548 South Lowe
Chicago, IL 60628

Donations for the Newly Formed Foundation can be sent to the following (checks or money order):
The Julius Montgomery Foundation
c/o Latisha S. Montgomery
12548 South Lowe
Chicago, IL 60628

Donations to the Julius Montgomery Foundation will be tax deductible (application for 501(c)(3) status is submitted.

Thursday, September 19, 2013

Betrayed by the System


As a child growing up, I was conditioned to trust in the 'system.' That system includes law enforcement, civil servants, health care professionals, religious leaders and our government. It’s just what you're supposed to do. Then, one day, you learn that not everyone in the system can be trusted and you feel an emotion that rattles you - betrayal.

So many of us have been let down in life by one event or another; it happens to all of us; but to be betrayed by those that we elevate on a pedestal? That brings out a completely new set of emotions that some of us have a hard time dealing with.

A few weeks ago, the realization hit me hard that my OB/GYN went into rock star mode for one reason and one alone, to SAVE his butt. I spent a few days in a complete funk. He wasn't treating me to help me; he was treating me to save himself because he should have never implanted me with Essure because of my known allergy and he did it again. He was and is directly responsible for my suffering.

I wish I was the only one in our Facebook group who had to deal with this emotion. Sadly, it’s very common. Women are suffering with real symptoms, experiencing real pain, and they are ignored or worse, they can't get help because so many medical professionals don't know what Essure is. This is very evident with our experiences in emergency rooms.

A woman is in real pain, and she goes to get help from her local emergency pain. She is met with blank stares when she says she has Essure. She gets a CT scan or an x-ray and the technician looks at her funny when she they see a foreign body in her lower abdomen. No one at the hospital is capable of reading the images to determining if the coils are in the proper place or if they are malformed. She's offered pain pills and sent back to her OB/GYN. At her OB/GYN, the treatment is not much better and these are from the physicians who are supposed to be the experts on the device.

How can a physician tell a woman she isn't feeling what she is really feeling?

Patient: I'm in pain
Doctor: No, you're not; it's in your head

Patient: I've been bleeding uncontrollably for months.
Doctor: That's normal. (ummmm - NO)

Patient: I wake up in the morning with a flat stomach. By the time I'm ready for bed, I look seven months pregnant
Doctor: You need to work on your diet (really)

Patient: I went to the ER and they took an x-ray because my pain. The coils don't look right; maybe they have moved
Doctor: No they haven't.
Patient: How do you know?
Doctor: Because I know they don't move. They just don't (Yes, they do)

Those are just a few of the real scenarios that women have faced with their doctors. All of these women had real symptoms of Essure ignored. To get help, we sadly have to suggest to them they don't even mention Essure. To say the word seems to be the kiss of death when it comes to being taken seriously.

When doctors take the Hippocratic Oath, they pledge to prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone.

My ire with the FDA continues to grow every day. Another day has passed, and it’s another day with no type of warning, no type of recall and no response to my FOIA. We've also learned how deceptive they are with their own budgeting and advisory committee meetings. This is the week I had planned to be in Washington DC prepping with the Center for American Justice for a meeting that was on the calendar with the FDA. It’s the advisory committee for OB/GYN devices. The meeting was calendared and the FDA was awarded budget for this. I learned from the FDA that even though it was budgeted and calendared, they don't confirm the meeting and the advisory committee hasn't met in years - and that's our tax dollars hard at work.

The system is a joke and it’s failed every single person impacted by Essure, everyone.

Wednesday, September 18, 2013

The Birth of an Activist


Someone asked me how I went from a Victim to Advocate and then Activist. If you look at organizations like the Susan G. Komen Foundation or Mothers against Drunk Drivers, or the Jimmy Rice Foundation or National Center for Missing and Exploited Children; they all started with a moment in life that changed them forever. Sadly, they are a moment or moments which can only be described as 'Life Altering.'

As you know from previous entries, my Essure coils were surgically removed in October of 2012. I could have just left the Essure Problems Facebook group as I was one of the lucky ones to become e-free, however, that wasn't an option for me. I was already too emotionally invested in the cause and the metamorphosis to Activist had already begun. I had several of those moments caused by Essure which impacted me so deeply that I simply could NOT go away quietly knowing that others could experience what I did.

You see, Essure robbed me of so much. It almost made my child as orphan as I could have died when I started bleeding uncontrollably - I'm the only parent. I could have died on the operating table having the two surgical procedures required to repair the damage caused by Essure and to free me of these nightmarish things. The man I was crazy about walked away from me two days after my bleeding episode because "he didn't sign up for this." The backstage mom of a dancer was stuck in the audience because I was too sick to help my daughter with hair / makeup / costume changes. This doesn't even touch on the things I simply forgot because my short-term memory still isn't the same because of Essure. I lost all of this because of birth control, JUST birth control.

ANGER - it’s a very powerful emotion and when you channel anger, you can change the world. I won't go as far as say that I want to change the world, just a piece of it, the piece that has directly angered me - Essure and the FDA.

When it comes to the FDA, boy, I was sure naive. I foolishly thought they are watching out for me. That couldn't be further than the truth. The FDA approves medical devices, but for them to actually do something when injuries are caused by medical devices, that's almost laughable. They'll let the manufacturer explain "it" away and the complaint will be filed. It's probably filed in the same place as my FOIA request. Anyway, the FDA puts more value on studies paid for and performed by doctors employed by or affiliated with the device manufacturer than they do in the words of women who are injured. The FDA doesn't even do their own studies? The whole process is a JOKE... To date, there have been more women injured by Essure than the total number of women included in the clinical trials.

Essure is now owned by Bayer and they are on a mission to cover their tracks and protect their ass-ets. They know we can't sue them; they purposely sought out PMA to protect themselves from the liabilities they know they are causing. They also know that nickel is a problem. They can't deny this as seven studies have been performed and in each and every one, they purposely exclude women who have nickel allergy. Knowing this, they still sought and received approval to remove the nickel warning from the label. Yes, the FDA approved the label change.

The emotional attachment to so many of the victims of Essure feeds my anger. Anger bread from sadness is more powerful than anger itself. The stories of those who are injured keep me going on the days where I think I can't keep going.

Essure off the market, and then the FDA needs to duck... Can't take out one without the other and they are both in the red zone.

Tuesday, September 17, 2013

The Gates Foundation Includes Essure in its 2011 Contraceptive Initiative


Below is correspondence I sent electronically to many within the Bill and Melinda Gates Foundation. The email was sent after Angela Lynch, one of the administrators of the Essure Problems Facebook group, learned that Essure was included in the Gates Foundation 2011 Contraceptive Initiative. The document is in the link below, and its one simple word, which you can find on page 9.

Here I am, a mom injured by this device, with firsthand knowledge of how crippling the side effects of this device can be if they happen, and one of the most respected women in America, who has the ability to affect change with one word, is dispensing Essure. No, no, no, no, no!!! Can you tell this bothered me? Well, it bothered many of us in the group.

Admittedly, many of us, including me, went off on a tangent that wasn't positive. As I was writing the first draft of the letter, I took a moment to really think about how to approach the Gates Foundation. As large as the Gates Foundation is, there is no way Bill and/or Melinda Gates are involved in every decision made. I have no way of knowing what they actually 'touch' or what is handled on their behalf. Maybe they don't know Essure is included, and more importantly, maybe they don't know about the countless women who have been injured by the device. The letter morphed into knowledge sharing with the hope of establishing a dialogue with someone at the Gates Foundation. I even included my phone number in the email. The email was received by many at the Foundation as only 3 of the 19 email addresses used were not valid. As of the writing of this blog, I've not received a response in any kind from anyone.

Women in the United States struggle with getting relief; who is going to help the women living in a remote village? In a third world country? Living in the mountains? The side effects aren't always gynecological in nature and these women may not know what is making them sick if they become sick. It was the lack of response that inspired the name of the blog. It’s not that I'm against Melinda Gates; she has the ability to do so much good, and she does do a lot of good. There are many working for them and I'm sure each device wasn't fully vetted. Essure is FDA approved, so "it’s got to be safe." If it wasn't safe, the FDA would issue a warning or something. These are reasonable assumptions, until you meet someone like me, who believed the same thing and suffered at levels very few can imagine, appreciate or even understand.

The battle against Essure continues and maybe someday, I'll be able to say that I influenced Melinda Gates to remove the device from those used by the Gates Foundation.


Dear Sir and Madam;

I recently learned that the Bill and Melinda Gates Foundation is supporting the use of Essure as part of your 2011 Contraception Initiative. My first thought was How Could You! My next thought was maybe you don’t know what Essure really does. It’s the latter of the two instincts which prompted this letter.

It is my sincere hope that this letter will prompt a dialogue so I can share with you the knowledge I have about the dangers of Essure with the hope that your organization will immediately withdraw your support of this device. Essure is a form of birth control in which two coils, made of nickel titanium alloy and PET fibers are implanted in the fallopian tubes of fertile women. It’s touted to be the non-surgical alternative to a tubal ligation. This device, by design, causes an auto-immune response which triggers the growth of scar tissue which blocks the tube and inhibits pregnancy. The Essure sales pitch, which was probably delivered to someone in your foundation who is a professional sales person or lobbyist, is sugar coated and it not true to reality. I can say this as I got the same sales pitch from my doctor. Essure is a classic example of “if it sounds too good to be true…..”

I co-admin a Facebook group called Essure Problems. We are over 2000 women strong and growing, and sadly, joined together because we have been severely and significantly damaged by Essure. When I joined the group in May of last year, there were only 30 members, and we are growing exponentially. Women are suffering with a myriad of symptoms, some of which mirror the effects of heavy metal poisoning or a severe reaction to the metals in the device. These symptoms include, but not limited to, severe and debilitating abdominal pain, irregular bleeding, dizziness, numbness, memory loss and tingling in their extremities and many other symptoms. The women in our group have been diagnosed with a multitude of illnesses including fibromyalgia, chronic fatigue syndrome, endometriosis and even multiple sclerosis. All of these women, including me, were healthy and presented none of these symptoms before they were implanted with Essure. Coils are also perforating the fallopian tubes, migrating within the body, being expelled into the uterus and breaking inside the body.

Sadly, many women within the United States are not able to get help from their physicians when they do have complications. They are ignored, told it’s in their head, misdiagnosed, and left to suffer with nightmarish side effects that destroy their quality of life. If women in the United States can’t get help, who is going to help the women in a third world country when/if she begins to suffer side effects?

For those who are fortunate to have the coils removed, the majority of the symptoms dissipate, however, no one is ever the person they were before Essure. The only way to remove the coils is with major surgery, a hysterectomy or salpingectomy. Women as young as 24 have had to have a hysterectomy to remove the devices. The removal protocol available in 2012 states only a salpingectomy is necessary, however, when doctors are performing surgery, the amount of damage caused by the devices requires more tissue to be removed. This protocol also only works if the devices haven’t migrated. There is no removal protocol documented for cases where the coils are no longer in the fallopian tubes.

It is NOT stated on any of the documentation from Bayer / Conceptus, specifically the patient information book, package insert or instructions for use, that a hysterectomy is a possible side effect. This seems to have been a conscious decision as the manufacturer knew no one would chose this product if they knew it could lead to a hysterectomy.

Sadly, some women are unable to get relief because they lack health insurance or the financial means to pay for removal. How are women in India, China, or some African nation supposed to get treated? Did your funding plan for that or are you going to leave them alone to suffer?

As you may have noted from my letter, this cause is very personal to me. I chose to have Essure because it was non-surgical. I ended up having multiple medical procedures to repair the damage caused to me by this device. I am very lucky to be here today writing this letter as my complications were so severe that I hemorrhaged and could have bled to death. I suffered for two years and this impacted my daughter as there were times when I was too sick to be a mom. Children have less of a mom, and husbands have less of a wife, and it’s all because of Essure. No one should have to endure this. Its madness and it needs to stop. Its only a matter of time before someone is not able to survive the complications.

I have a myriad of documents which substantiate that Essure is a form of birth control that simply should not be on the market, including the documents from the clinical trials. Don’t be guided by my story alone. Many women have posted their Essure nightmares at, a website started for us by Erin Brockovich who is also supporting the fight against this device.

I welcome the opportunity to speak with any and all of you, and whomever else within your organization about Essure. I truly believe you didn’t know what was sold to you and this is your opportunity to send a loud and clear message about the dangers of Essure. What has happened to the ladies in my group continues to happen and no one deserves to suffer like this. You have the power to send a loud and clear message about the questionable safety of this device by removing its use from any and all programs supported by the Bill and Melinda Gates foundation.


Michelle Garcia

Monday, September 16, 2013

e-hell - What Essure did to me and my family


I start this entry with a heavy heart as there are 15 women from the Essure Problems Facebook group scheduled for major surgery this week. The specific surgery is a hysterectomy, which is necessary to remove Essure for women who are suffering for severe side effects called by Essure. You may recall that in my first blog, I shared some of the side effects; that is just some of the effects. I'll expand on this after I share with you my personal story of e-hell.

The start of my e-hell began with my never having a normal cycle again. I had a period in June, but it lasted only two or three days. Then nothing for months; no July, August or September. I thought that was weird, but when I asked, the dr. said it was normal. This is the irregular bleeding they spoke about. Then in October, I got two periods in the same month. That has never happened to me before.

In early December, I started bleeding, and I didn't stop for months. I had to wear a pad everyday because something was always coming out of me. I gave up on wearing white and forget about a bathing suit. December was also a sad month for a few other reasons. My daughter was performing at a dance convention in Orlando. I always did her hair and makeup. Sadly, that didn't happen for this event as I was in our hotel room with a migraine from hell and not only did I not do her hair or makeup, I also didn't see her dance. I was the mom who was always there for everything for my child. Essure stole that when it robbed me of my health.

In February or March of 2012, my GYN performed a biopsy to determine why I was constantly bleeding. Those tests came back as negative for anything wrong and negative for a reason why I just kept bleeding. It was about the same time, I noted the sharp, stabbing abdominal pains. The stabs felt like someone had a knife and they were stabbing me from the inside. When they got my attention, the pains would last seconds, with a scale or 5 or 6. I was having two or three episodes a day. Over time, the frequency and severity increased. At its peak, I was having 8 or 9 episodes a day at a pain scale of 9 or 10. Yes, 10.

Finally in April, I suddenly stopped bleeding. It was a relief and my thoughts are maybe I'm finally back to normal. That couldn't be further from the truth. I'll never forget May 18, 2012. The day before, I spotted a bit and wore a pad to work that day. I was sitting in a mid-morning meeting, and I started bleeding a lot. Within seconds, the pad I was wearing was soaked through and I could feel the cushion of the chair I was sitting absorbing the blood also. Somehow, I managed to leave the room without losing my composure, and got to my desk. By this time, I have blood dripping down my leg, I'm very shaky, pale, and my composure is gone. One of my co-workers got me to the hospital. This is what I learned how little hospitals know about Essure or even how to manage patients have a gynecological crisis. I bled for about 2 hours straight, and it stopped on its own after two hours. The hospital performed no diagnostic tests, no CT scan, no ultra-sound, no nothing. They basically said you're not bleeding anymore and sent me on my way. They gave to me a verbal diagnosis, I hemorrhaged, and a diagnosis on paper, heavy periods. I spent the next few days at home laying on the couch with no energy. My mom said something which triggered me to start looking. She said 'maybe the Essure thing is the problem.' It was that day that I found and joined Essure Problems on Facebook, which had maybe 30 members. I was amazed at how much I had in common with these women. We had some very similar issues and we were all convinced it was Essure. I also found a few other pages on other websites which talked about Essure causing problems. These were pages I had never seen before.

I saw my GYN on Monday, showed him what I found, and he said it may be Essure, it may not be and I had tons of tests performed on me that day and for the next few days. My GYN also spoke to my primary physician and it seemed that my primary was going to be engaged with figuring out what was wrong with me. I had been complaining about other symptoms to my primary for months, and he couldn't find anything wrong. Some of the other symptoms included dizzy spells, numbness / tingling in my extremities, my memory wasn't the same, my energy level was gone, and I just generally felt like crap all the time. All the while, I still had that sharp stabbing pain. My migraines also got worse; the increased in frequency and intensity. After getting a battery of tests, I saw my primary and his response to me was lose weight. I know that carrying extra pounds can lead to a few other health conditions, but there is NO WAY that would cause me to lose copious amounts of blood. I left his office and never went back.

My GYN then started ordering tests that would normally be done by the PCP. One of the tests was an abdominal CT scan. My GYN said this test showed I had developed a seroma in my abdomen and this was probably the source of the pain. This test also showed a coil fragment in my abdomen, but he neglected to tell me this. I found out about the coil fragment later. On June 20th, I had an outpatient surgical procedure, which drained the seroma. For a few days, even the sharp stabbing pain went away. That was short lived.

By early July, the stabbing was back. It started slowly, once or twice a day and got progressively worse. Anyone who sat around me at work knew when I was getting stabbed; it showed in my face and they would also see me doubled over grabbing my side. They knew they started again when the same doubling over started again. My GYN referred me to a gynecological surgeon as he agreed to finally take them out. On my first appointment with Dr. Jacob Tangier, I was sitting in the waiting room and there was a woman next to me who was clearly suffering with some form of cancer. I remember telling Dr. Tangier that I could wait if she needed to be seen first. He said that you wouldn't be here if you didn't need to me and I KNEW I had found the doctor who would free me of these coils. He already had a copy of my records and asked that I get a copy of the CT scan I had in June which showed the seroma. The next appointment with him he said before surgery he wants another CT scan to make sure the coil hadn't moved. I said what coil? It was that day I learned that the Essure coil had broke in my body, and the fragment perforated my fallopian tube and it had migrated to my abdomen. My GYN didn't tell me this. Mistake #2.

I used to say that my GYN went into rock star mode. Sadly, I've come to realize that he only went above and beyond to cover his mistakes. I have a known allergy to IV Iodine which was discovered when I was in my early twenties when I went into anaphylaxis during a diagnostic procedure. Because of this known allergy, which is in my chart in his office, I should have never been implanted as the Essure documentation states that anyone with a known allergy should not have the procedure. This is NOT listed on any patient material, but it is on the material for the physicians who perform the procedure. He messed up, got paid and I suffered.

I was scheduled for Essure removal via bi-lateral salpingectomy and removal of the coil fragment in my abdomen. Finally, I would be getting these nightmarish devices of out me. I was about to have major surgery and I was excited. Yes, excited. Something is seriously wrong when major surgery becomes a happy moment. Essure robs you of your quality of life and makes the whole family suffer because Mom is too sick to me a mom. Because of Essure, I suffered physically, emotionally and psychologically. All I did was sign up for birth control, just birth control. To avoid one surgery, I ended up having two. Essure destroyed my insides.

Slowly over time, I'm getting my life back, but my Essure story is far from over.

Sunday, September 15, 2013



Thanks for reading the first of many entries in my blog. I'm sure many of you are wondering why I chose to name Melinda Gates in the title and why an ordinary person is choosing to call out someone extra-ordinary. Well, that's an easy one. I became extra-ordinary the day that a defective birth control device called Essure almost ended my life. How we got to Vs. Melinda Gates is a story two years in the making so let's go back two years and get you caught up.

In April of 2011, I became a patient of Essure. My doctor knew I didn't want any more children; I have one daughter, who is simply the most amazing child. I was 38 years old at the time at the time. Do that math, with child #2 we'd be going through puberty and menopause at the same time. That was as unappealing as the possibility of a high risk pregnancy. I have no regrets about my personal decision to have no more children. I do, however, regret the decision to get Essure every day. Just last week, I learned I should have never been a patient in the first place. We'll get to the later.

You're probably asking what is Essure? I'm happy to tell you. During the past two years, I've learned quite a bit about the device. You see, when you're in a battle against something, you better become an expert. You can't fight what you don't know and I know more about Essure than many doctors. Sad, but true. In fact, there are lots of women who have become experts on this device. One who knows more than me is Angie Firmalino, she's my e-sister and together with a few other amazing ladies, we co-admin a facebook group called Essure Problems. Essure Problems is a group of ladies whose lives have been irreversibly damaged by Essure. We also have a few spouses on the page who support their significant others.

Back to what Essure is - the device is two small coils which are made of a nickel-titanium alloy and PET fibers. When the Essure coils are inserted in the fallopian tubes, an inflammatory response is triggered which causes scar tissue to develop around the coil and this scar tissue is supposed to 'occlude' or block your fallopian tubes. In theory, it sounds great. Sadly, it's only a theory, because for me and the 2000+ women in our group, it's our worst nightmare. I wish I knew in 2011 what I know now. When I was implanted, there was very little about Essure on the web, and despite my research, I never found anything bad about it. It was described as the non-surgical alternative to a tubal ligation. That worked for me as I didn't want surgery. It was also described as virtually painless and easily performed in the doctor's office. I would be back to normal activities the next day. The side effects were described as cramping and irregular bleeding. It sounded like the optimal solution for me. Too bad that Essure is NOTHING like it was described.

Let's start with the day of insertion - they give you medication to take at home so you're comfortable. NO, they give you medication so you end up STONED. By the time of my procedure at 11am, I had already taken four Percocet. Again, this is what they prescribed. The quick and painless procedure was NOT quick and it was NOT painless. Only one coil was successfully implanted that day, and it took over 30 minutes. I remember severe pain that brought me to tears, and cramping that was extreme. If I wasn't so stoned, I probably would have screamed and jumped off the table. I was also given a shot and told to come back in a month to try to place the second coil. I wish I would have never gone back.

After the first coil was placed, I spotted for several days. I was told it was normal. About two weeks later, I got a period and it was nothing like my typical cycle. I was told that was because of the shot. Over time, I learned it may not have been the shot.

I went for the second coil in May and it was just like the first, painful!!! There was also a rep from Conceptus in the room observing. This also took more than 10 minutes. In the Essure documentation provided to physicians, the procedure should be aborted after 10 minutes. My doctor violated this protocol and this is NOT the 1st mistake he made when it came to my care.

Prior to becoming an Essure patient, I had periods that were very regular, and virtually painless. I was the one that everyone else hated because I had no symptoms to go along with a monthly cycle; no cramps, no bloating, no irritability, no nothing. The only way I knew it was that time of the month was the bleeding. My last regular period was in April of 2011, right before I was inserted with Essure.

This leads to the beginning of e-HELL which will be described in upcoming entries.