For Immediate Release
Essure Victims Challenge Global Sales Numbers of Essure Reported by Bayer
By Michelle Garcia
November 11, 2013
Miami, Florida: Women injured by Essure are crying foul to the statements made by Bayer that more than 750,000 women have been implanted by Essure worldwide, and they are using the company’s own documentation to support their claims.
“The number of women implanted have been grossly overstated in what can only be perceived as a blatant attempt to minimize the suffering caused to so many women by this device,” said Angie Firmalino, a victim of Essure who is working directly with Erin Brockovich to get Essure off the market. Bayer’s own documentation seems to support this statement. Page 3 of the Essure Instructions for Use, with a copyright date of 2013, which is found on the company’s own website, http://www.essuremd.com/, states the ”number of pregnancies reported from worldwide commercial launch in 2001 through end of 2010. 497,306 Essure kits sold during this time.” If this number is correct, then Bayer sales of Essure nearly doubled in a period of approximately one year. The same document also states “the number of devices actually implanted is not known.”
Angie Firmalino is one of the leaders of a Facebook group called Essure Problems which is challenging the safety and effectiveness of Essure, as well to help the many who at times, find themselves shunned by the doctors. She also maintains a website, www.essureproblems.webs.com, which has numerous photographs of mangled coils that have been surgically removed.
There is a perception that kits sold equates to women implanted. There are many women who have documentation which states that multiple kits were used during their procedure. “A sold kit is not a patient,’ says Firmalino, who is using evidence from ladies in her own group. A number of ladies in the group, including those who lead the group with Firmalino have multiple lot numbers, including one who was implanted on two separate days as her physician was unable to successfully achieve bi-lateral placement on the first visit. It took a second visit a month later to place the second coil. These women have patient information cards and medical records from their implanting doctors confirming that multiple kits were used during implantation. These same women wonder if Bayer has any idea of how many women have actually been implanted.
For information about the women who have been harmed by Essure, including contact information to interview women from specific cities or medical experts concerned about the safety of Essure, contact Michelle Garcia via email at Essureproblems@yahoo.com.
Tuesday, November 12, 2013
Saturday, November 9, 2013
Essure Victims Meet With Executive Committee of AALG to Raise Awareness
For Immediate Release
Essure Victims Meet With Executive Committee of AALG to Raise Awareness
By Michelle Garcia
November 9, 2013
National Harbor, Oxenhill, MD: The leaders of the Essure Problems Facebook Group came to the Nation’s Capital ready to raise awareness to the harm caused to thousands by Essure. They found themselves unable to walk down the street without being approached by Surgeons who are familiar with Essure. These doctors expressed genuine sincerity about the issues women implanted by Essure have experienced and also expressed their gratitude for the efforts of the leadership to raise awareness to the dangers and unknown side effects caused by this device.
The greatest accomplishment was a meeting with the same leadership group and the Executive Committee of the AAGL, http://www.aagl.org/. Members of the Executive Committee, including Dr. Kenneth Loffer, FACOG, Executive VP/Medical Director and Ms. Linda Michels, Executive Director, were fully engaged for the hour long discussion where concerns were presented along with supporting documentation. The leadership of the AAGL committed to assisting women harmed by Essure with finding physicians with Essure removal, as well as unbiased studies into the safety and effectiveness of the device and most important, sending a memo to the thousands of physicians in their organization about the issues being raised so that proper attention can be paid to women who may be suffering because of adverse effects caused by Essure.
The meeting was planned to coincide with Essure Awareness Day, which is November 10th. This is also the start of Global Congress on Minimally Invasive Gynecology held just outside Washington D.C. at the Gaylord Convention Center.
For information about the women who have been harmed by Essure, including contact information to interview women from specific cities or medical experts concerned about the safety of Essure, contact Michelle Garcia via email at Essureproblems@yahoo.com.
Essure Victims Meet With Executive Committee of AALG to Raise Awareness
By Michelle Garcia
November 9, 2013
National Harbor, Oxenhill, MD: The leaders of the Essure Problems Facebook Group came to the Nation’s Capital ready to raise awareness to the harm caused to thousands by Essure. They found themselves unable to walk down the street without being approached by Surgeons who are familiar with Essure. These doctors expressed genuine sincerity about the issues women implanted by Essure have experienced and also expressed their gratitude for the efforts of the leadership to raise awareness to the dangers and unknown side effects caused by this device.
The greatest accomplishment was a meeting with the same leadership group and the Executive Committee of the AAGL, http://www.aagl.org/. Members of the Executive Committee, including Dr. Kenneth Loffer, FACOG, Executive VP/Medical Director and Ms. Linda Michels, Executive Director, were fully engaged for the hour long discussion where concerns were presented along with supporting documentation. The leadership of the AAGL committed to assisting women harmed by Essure with finding physicians with Essure removal, as well as unbiased studies into the safety and effectiveness of the device and most important, sending a memo to the thousands of physicians in their organization about the issues being raised so that proper attention can be paid to women who may be suffering because of adverse effects caused by Essure.
The meeting was planned to coincide with Essure Awareness Day, which is November 10th. This is also the start of Global Congress on Minimally Invasive Gynecology held just outside Washington D.C. at the Gaylord Convention Center.
For information about the women who have been harmed by Essure, including contact information to interview women from specific cities or medical experts concerned about the safety of Essure, contact Michelle Garcia via email at Essureproblems@yahoo.com.
Monday, November 4, 2013
Essure Awareness Day
For Immediate Release
Women Harmed by Bayer’s Essure Permanent Birth Control Rally in Washington, DC To Demand New Safety Studies
Miami, Florida: With the support of Erin Brockovich, women representing the thousands of women harmed by Essure Permanent Birth Control are coming to Washington, DC on Sunday, Nov 10 from 9am to 6pm and Monday, Nov 11 from 9am to Noon to demand that doctors and the FDA conduct new safety studies. The women are from across the country, including Miami, Boston, Chicago, Baltimore, Cleveland, New York, Tampa and countless other cities across the country.
Essure is a permanent birth control device made by Bayer and approved by the FDA based on company studies indicating low complication rates and high effectiveness. A new investigation, http://www.nbcnewyork.com/investigations/Essure-Birth-Control-FDA-Pain-Studies-I-Team.html, indicates that women suffering from debilitating pain were inaccurately reported by the company as having “excellent” responses to the birth control and being “very satisfied” with the device.
Sunday, Nov 10 will be Essure Awareness Day, as the women rally at the annual conference of the Global Congress on Minimally Invasive Gynecology will be held just outside Washington D.C. at the Gaylord Convention Center. http://www.aagl.org/annual-meeting/
The women will rally to demand that the FDA require new studies to replace the biased data revealed by NBC-TV’s Investigative team, http://www.nbcnewyork.com/investigations/Essure-Birth-Control-FDA-Pain-Studies-I-Team.html.
For information about the women who have been harmed by Essure, including contact information to interview women from specific cities or medical experts concerned about the safety of Essure, contact Michelle Garcia via email at Essureproblems@yahoo.com.
Women Harmed by Bayer’s Essure Permanent Birth Control Rally in Washington, DC To Demand New Safety Studies
Miami, Florida: With the support of Erin Brockovich, women representing the thousands of women harmed by Essure Permanent Birth Control are coming to Washington, DC on Sunday, Nov 10 from 9am to 6pm and Monday, Nov 11 from 9am to Noon to demand that doctors and the FDA conduct new safety studies. The women are from across the country, including Miami, Boston, Chicago, Baltimore, Cleveland, New York, Tampa and countless other cities across the country.
Essure is a permanent birth control device made by Bayer and approved by the FDA based on company studies indicating low complication rates and high effectiveness. A new investigation, http://www.nbcnewyork.com/investigations/Essure-Birth-Control-FDA-Pain-Studies-I-Team.html, indicates that women suffering from debilitating pain were inaccurately reported by the company as having “excellent” responses to the birth control and being “very satisfied” with the device.
Sunday, Nov 10 will be Essure Awareness Day, as the women rally at the annual conference of the Global Congress on Minimally Invasive Gynecology will be held just outside Washington D.C. at the Gaylord Convention Center. http://www.aagl.org/annual-meeting/
The women will rally to demand that the FDA require new studies to replace the biased data revealed by NBC-TV’s Investigative team, http://www.nbcnewyork.com/investigations/Essure-Birth-Control-FDA-Pain-Studies-I-Team.html.
For information about the women who have been harmed by Essure, including contact information to interview women from specific cities or medical experts concerned about the safety of Essure, contact Michelle Garcia via email at Essureproblems@yahoo.com.
Sunday, October 13, 2013
Essure's Lost Souls
Hello,
Many of you have read the story about baby Julius and the story about baby Machin. They are just two of the countless victims who might be forgotten if it wasn’t for the story I’m about to write. These are the babies that were never born or the babies that didn’t grow to develop a heartbeat, or even a heart, the babies lost because these simply weren’t meant to be. This entry is dedicated to the e-babies lost due to a miscarriage and to their mom who suffered emotionally when they lost the baby.
On its website, Essure claims to be permanent birth control “to help you live without the worry of an unplanned pregnancy.” Women find out they are pregnant and the initial feeling are shock. After all, they have been told pregnancy is impossible by their doctors. Women are nurturers by nature, and after the shock wears off, the same feelings they felt with their other pregnancies start to surface. Pregnancy brought joy and happiness to these families. Even though their “family is complete,” they were going to make room for one more. Sadly, for so many, their unplanned pregnancy ended with a heart breaking miscarriage.
Florence has only one tube left because of damage caused by Essure. She was e-free at the time of her miscarriage, a baby conceived only 5 short weeks ago. This little life didn’t stand a chance. The fertilized egg was not able to travel into her uterus because of the significant scar tissue present in the one remaining tube. She suffered from the physical pain of an ectopic pregnancy and the emotional pain of a miscarriage. Had the decision been hers, she would have given birth to this little miracle baby, however, the decision wasn’t hers to make. She is so grateful that she didn’t have to undergo surgery to removal the tubal pregnancy as her body made the decision for her, the excitement of pregnancy taken away.
Maria is 35 years old. She is the mother of three boys and she didn’t want more children. She ended up with Essure when her doctor didn’t want to perform a tubal ligation because it ‘seemed to be too much trouble” over the weekend. He also said Essure was 100% effective and has no side effects. She feels like she was lied to, and based on everything I know, I have to agree with her. She wasn’t able to get an HSG because she lost her insurance. Sadly, she wasn’t even aware she was pregnant when she suffered a miscarriage. She was woken from a deep slumber on the morning of July 21, a Sunday she’ll never forget. She was in severe pain and passing very large baseball sized blood clots. She bled like this for 12 days thinking is was another one of those “abnormal” periods which had become the norm since Essure. The pain continued and she was also experiencing fevers and chills. She finally went to the emergency room where she was told she was pregnant and this pregnancy was ectopic. She also learned the Essure device had migrated and was logged in her fallopian tube. On August 27, she suffered a miscarriage and the baby left her body. She calls August 27th the worst day of her life. Sadly, she continues to suffer with the other symptoms which seem to be caused by Essure including mood swings, sharp abdominal pain, migraines and muscle pain. Essure is an endless nightmare that caused her heartbreak.
Heartbreaking is how Melissa describes the experience of knowing she lost her baby. She woke in the middle of the night covered in blood, and managed to get to the bathroom to clean up. She then started passing clots. Because she had been sterilized with Essure, being pregnant was the furthest thought from her mind. Thirteen months prior, her marriage had crumbled and she was now very happily involved with a new man who she was going to marry. Sadly, the children they wanted together weren’t possible, at least, weren’t’ supposed to be possible. After all, Essure is ‘highly effective’ and ‘permanent.’ Three days before the miscarriage, a home pregnancy test showed she was pregnant. She and her fiancé were over the moon with joy. A visit to the doctor’s office confirmed her worst fear; she suffered a miscarriage that night. When she lost the baby, she didn't know how to feel. She cried all night for the baby she lost and everything Essure has made me lose since I had it done. She is not the person she was before Essure. Time with her kids was gone, her marriage was gone, and the dream of a second chance family to add to her family with her first husband was also lost. Instead of joy, she is now looking at a hysterectomy at 31.
Tammy kept telling herself she wasn’t pregnant, but she was feeling pregnant. She was second guessing how she was feeling because she had Essure and Essure is permanent and effective. About a month later, her husband told her she pregnant. She remembers yelling at him in denial. She remembers saying ‘I can’t get pregnant.’ She even went as far as to show him the Essure website just to prove to him and to herself that she wasn’t carrying a baby. She took three home pregnancy tests and they all showed negative. She then looked on the web expecting to find more proof to show him. Instead, she found that Essure wasn’t as effective as she was told by her doctor and it’s possible she was pregnant. Tammy and her husband have always dreamed of a big family. Sadly, the big family wasn’t an option and she suffered four miscarriages before Essure. She chose to get Essure because of the emotional toll of the miscarriages. Little did she know, Essure would only lead to more pain. An ultrasound confirmed she was pregnant. The same ultrasound showed she had an Essure coil expelling out of her fallopian tube into her uterus. She was sent to the emergency room where she suffered her fifth miscarriage, and first caused by Essure. She experienced joy and sadness all in one day. This is more emotions than one person should have to process in one day.
Marcia found herself 16 days late and feeling nauseous and tired. She was also experiencing breast pain, which is a common sign of pregnancy. She had had Essure for 7 months and like the other ladies in these stories, pregnancy was the further from her mind. Essure is, after all, very effective. She took a pregnancy test anyway, and was shocked to see a positive result. Three days later, she drove to Illinois and unpacked her van. A few hours later, she was suffering from severe back pain, and cramping. She went to the bathroom thinking her period finally started. She simply didn’t believe the positive home test because she had Essure. Remember it’s highly effective. Her ‘period’ wasn’t normal at all. She was passing clots of all sizes and grey looking tissue. She sent pictures to a friend who is a nurse. Her friend asked her about the results of the home pregnancy test. When Marcia told her it was positive, her friend told her that she already knew what it was. Marcia estimates she was about 7 weeks when she lost this baby. She had two babies under three at home, including one that was suffered with severe reflux. They say that you are never given more than you can handle, and what happens next is in God’s hands. Even though she was in denial, she was actually getting used to the idea of being pregnant. She held in lots of emotions until she got home. She cried in her husband’s arms and somehow manages to get along with daily life. She didn’t mourn until very recently when the realization hit her. She would have had a 1 year old running around with her 3 1/2 year old and 2 year old.
Gina had Essure done in 2011. In October, 2012, she suffered the sadness that comes with a miscarriage when she lost the baby she had been carrying for 13 weeks. She was shocked, and super excited when she found out she was pregnant. Her husband, active duty military, had just deployed and she couldn’t wait to give him the news via Skype. Sadly, she wouldn’t be able to share the news of a positive test. Instead, through tears and across thousands of miles, she would have to share with her husband that she suffered horrible bleeding which resulted in her going to the emergency room. While at the emergency room, she would watch on an ultrasound screen the image of her baby as it slowly lost its heartbeat one the screen in front of her. She watched her baby die. Gina had to deliver this baby, which was a baby girl that she named Aurora. Her doctor believes that an Essure coil caused a perforation that resulted in the miscarriage. Aurora will always be in Gina’s heart. She is the reason that Gina fights against Essure. No one should stare a screen and watch their baby die.
These are just a few of the stories representing the unborn babies lost because of Essure. These little ones never had a chance and their mom’s will never forget them.
Many of you have read the story about baby Julius and the story about baby Machin. They are just two of the countless victims who might be forgotten if it wasn’t for the story I’m about to write. These are the babies that were never born or the babies that didn’t grow to develop a heartbeat, or even a heart, the babies lost because these simply weren’t meant to be. This entry is dedicated to the e-babies lost due to a miscarriage and to their mom who suffered emotionally when they lost the baby.
On its website, Essure claims to be permanent birth control “to help you live without the worry of an unplanned pregnancy.” Women find out they are pregnant and the initial feeling are shock. After all, they have been told pregnancy is impossible by their doctors. Women are nurturers by nature, and after the shock wears off, the same feelings they felt with their other pregnancies start to surface. Pregnancy brought joy and happiness to these families. Even though their “family is complete,” they were going to make room for one more. Sadly, for so many, their unplanned pregnancy ended with a heart breaking miscarriage.
Florence has only one tube left because of damage caused by Essure. She was e-free at the time of her miscarriage, a baby conceived only 5 short weeks ago. This little life didn’t stand a chance. The fertilized egg was not able to travel into her uterus because of the significant scar tissue present in the one remaining tube. She suffered from the physical pain of an ectopic pregnancy and the emotional pain of a miscarriage. Had the decision been hers, she would have given birth to this little miracle baby, however, the decision wasn’t hers to make. She is so grateful that she didn’t have to undergo surgery to removal the tubal pregnancy as her body made the decision for her, the excitement of pregnancy taken away.
Maria is 35 years old. She is the mother of three boys and she didn’t want more children. She ended up with Essure when her doctor didn’t want to perform a tubal ligation because it ‘seemed to be too much trouble” over the weekend. He also said Essure was 100% effective and has no side effects. She feels like she was lied to, and based on everything I know, I have to agree with her. She wasn’t able to get an HSG because she lost her insurance. Sadly, she wasn’t even aware she was pregnant when she suffered a miscarriage. She was woken from a deep slumber on the morning of July 21, a Sunday she’ll never forget. She was in severe pain and passing very large baseball sized blood clots. She bled like this for 12 days thinking is was another one of those “abnormal” periods which had become the norm since Essure. The pain continued and she was also experiencing fevers and chills. She finally went to the emergency room where she was told she was pregnant and this pregnancy was ectopic. She also learned the Essure device had migrated and was logged in her fallopian tube. On August 27, she suffered a miscarriage and the baby left her body. She calls August 27th the worst day of her life. Sadly, she continues to suffer with the other symptoms which seem to be caused by Essure including mood swings, sharp abdominal pain, migraines and muscle pain. Essure is an endless nightmare that caused her heartbreak.
Heartbreaking is how Melissa describes the experience of knowing she lost her baby. She woke in the middle of the night covered in blood, and managed to get to the bathroom to clean up. She then started passing clots. Because she had been sterilized with Essure, being pregnant was the furthest thought from her mind. Thirteen months prior, her marriage had crumbled and she was now very happily involved with a new man who she was going to marry. Sadly, the children they wanted together weren’t possible, at least, weren’t’ supposed to be possible. After all, Essure is ‘highly effective’ and ‘permanent.’ Three days before the miscarriage, a home pregnancy test showed she was pregnant. She and her fiancé were over the moon with joy. A visit to the doctor’s office confirmed her worst fear; she suffered a miscarriage that night. When she lost the baby, she didn't know how to feel. She cried all night for the baby she lost and everything Essure has made me lose since I had it done. She is not the person she was before Essure. Time with her kids was gone, her marriage was gone, and the dream of a second chance family to add to her family with her first husband was also lost. Instead of joy, she is now looking at a hysterectomy at 31.
Tammy kept telling herself she wasn’t pregnant, but she was feeling pregnant. She was second guessing how she was feeling because she had Essure and Essure is permanent and effective. About a month later, her husband told her she pregnant. She remembers yelling at him in denial. She remembers saying ‘I can’t get pregnant.’ She even went as far as to show him the Essure website just to prove to him and to herself that she wasn’t carrying a baby. She took three home pregnancy tests and they all showed negative. She then looked on the web expecting to find more proof to show him. Instead, she found that Essure wasn’t as effective as she was told by her doctor and it’s possible she was pregnant. Tammy and her husband have always dreamed of a big family. Sadly, the big family wasn’t an option and she suffered four miscarriages before Essure. She chose to get Essure because of the emotional toll of the miscarriages. Little did she know, Essure would only lead to more pain. An ultrasound confirmed she was pregnant. The same ultrasound showed she had an Essure coil expelling out of her fallopian tube into her uterus. She was sent to the emergency room where she suffered her fifth miscarriage, and first caused by Essure. She experienced joy and sadness all in one day. This is more emotions than one person should have to process in one day.
Marcia found herself 16 days late and feeling nauseous and tired. She was also experiencing breast pain, which is a common sign of pregnancy. She had had Essure for 7 months and like the other ladies in these stories, pregnancy was the further from her mind. Essure is, after all, very effective. She took a pregnancy test anyway, and was shocked to see a positive result. Three days later, she drove to Illinois and unpacked her van. A few hours later, she was suffering from severe back pain, and cramping. She went to the bathroom thinking her period finally started. She simply didn’t believe the positive home test because she had Essure. Remember it’s highly effective. Her ‘period’ wasn’t normal at all. She was passing clots of all sizes and grey looking tissue. She sent pictures to a friend who is a nurse. Her friend asked her about the results of the home pregnancy test. When Marcia told her it was positive, her friend told her that she already knew what it was. Marcia estimates she was about 7 weeks when she lost this baby. She had two babies under three at home, including one that was suffered with severe reflux. They say that you are never given more than you can handle, and what happens next is in God’s hands. Even though she was in denial, she was actually getting used to the idea of being pregnant. She held in lots of emotions until she got home. She cried in her husband’s arms and somehow manages to get along with daily life. She didn’t mourn until very recently when the realization hit her. She would have had a 1 year old running around with her 3 1/2 year old and 2 year old.
Gina had Essure done in 2011. In October, 2012, she suffered the sadness that comes with a miscarriage when she lost the baby she had been carrying for 13 weeks. She was shocked, and super excited when she found out she was pregnant. Her husband, active duty military, had just deployed and she couldn’t wait to give him the news via Skype. Sadly, she wouldn’t be able to share the news of a positive test. Instead, through tears and across thousands of miles, she would have to share with her husband that she suffered horrible bleeding which resulted in her going to the emergency room. While at the emergency room, she would watch on an ultrasound screen the image of her baby as it slowly lost its heartbeat one the screen in front of her. She watched her baby die. Gina had to deliver this baby, which was a baby girl that she named Aurora. Her doctor believes that an Essure coil caused a perforation that resulted in the miscarriage. Aurora will always be in Gina’s heart. She is the reason that Gina fights against Essure. No one should stare a screen and watch their baby die.
These are just a few of the stories representing the unborn babies lost because of Essure. These little ones never had a chance and their mom’s will never forget them.
Thursday, October 3, 2013
Life Interrupted, the Story of Baby Machin
Hello,
As one of the administrators of the Essure Problems support page, I have read countless stories of pain and suffering caused by this nightmare device. A few months ago, a young woman reached out to share her story with me privately. Outside of her immediate circle, I was the only person who knew of the pain caused to her and her family by Essure. I write this one knowing that no matter how hard I try, I can never come up with the words to express that pain that Angela has felt. Those words just don't exist.
In June of 2011, Angela gave birth to her third child. She and her husband decided that Angela would have the Essure procedure done as it was highly recommended by her doctor. She had the procedure done in September of 2011, and at the time, she didn't regret her decision to be sterilized. She knew her family was complete. Three months later, in December, the HSG was performed and this test showed that her tubes were occluded and she was sterile.
Angela noted that she started having side effects shortly after the devices were implanted. Like so many women, she is allergic to nickel and she was not aware that Essure coils are made of a nickel alloy. Some of her symptoms included heavier periods, night sweats, fainting, cramping and severe lower back pains which resemble the back pain that women experience when they are in labor. Staying awake for longer than a few hours became a challenge and she felt like she was living in a drug induced state. Angela had three children, the youngest of which was not even a year old, and the issues with her health were impacting her ability to be a mom.
In April of 2012, Angela took a home pregnancy test. She didn't expect it to be positive as her doctor assured her that she could NOT get pregnant on Essure, especially after her HSG confirmed her fallopian tubes were blocked. The results of that home pregnancy test were positive. If that test was correct, she was now pregnant with her fourth child. Her doctor’s office refused to believe that Essure had failed and she was pregnant. A rep for Essure had even told her doctor that pregnancies with Essure are only the result of errors committed by the physician. Her doctor performed a blood test and this also showed she was pregnant.
Angela was told it was likely the pregnancy would be ectopic or end in a miscarriage due to the Essure devices. She thought this was a case as she was having significant cramping and spotting. Her doctor’s office performed an ultrasound and they shared with Angela that the gestational sac was about 4 times larger than normal, indicative of a pre miscarry situation. For the next several days, Angela lived with the symptoms of what she thought was a miscarriage. She and her husband struggled to come to terms with this sad loss. This, after the shock of finding out they were pregnant in the 1st place. Two weeks later, Angela was told by her doctor that she had not miscarried and that the pregnancy was progressing. This was just one of many moments on the emotional roller coaster for George and Angela. They had experienced the complete shock & then acceptance of an unplanned pregnancy, had decided to embrace the situation as they decided (along with the doctor) that it was a miracle baby. Then, they had mourned the impending loss of the miracle, only to have renewed joy when they learned the baby wasn't lost.
Angela's doctor was still very concerned about the baby. The enlarged gestational sac simply wasn't normal and he referred her to a gestational specialist. Over two separate visits, tests revealed the most heartbreaking scenario. The specialist determined that the baby was not developing properly. A diagnosis of extreme radial dysplasia or radial clubbing was shared with Angela and George. The doctor described the case as one of, if not the most, extreme he had seen. At first, they were told it was only on one side of the upper body, then it became both sides, and then it became club foot as well. The miracle baby was severely deformed. Sadly, they also learned that children with radial conditions generally experience other potentially life threatening disorders including cardiac and renal conditions. There were also strong concerns that neurological disorders may be present.
Angela started to research what may have caused this condition as she was assured that it was not genetic, and her 3 other children were all healthy. The only difference in this pregnancy was the presence of Essure. Angela discovered that Radial Clubbing is most often caused by exposure to a carcinogen during the first seven weeks of pregnancy. Essure is made out of nickel, which is a carcinogen. Angela lives in Texas and had no other environmental factors which would have contributed to this condition.
The news that was shared with George and Angela about the health issues impacting the baby were not shared in one visit. It happened over the course of several closely spaced visits. Each time they saw their doctor, it just got worse and worse. For this baby to have any chance at a somewhat normal life, multiple surgeries would have been necessary as soon as the baby was born, and that is only if the baby was able to be carried to term, and survived outside the womb. Normalcy for this baby would include a life bound to a wheelchair, as well as the necessity of other medical support devices. Again, that is if this baby survived outside the womb. Sadly, the odds were against this happening. With the doctor’s prognosis, George & Angela had to consider what would happen to the quality of life for their three existing children as well as the quality of life for the unborn baby.
Angela is riding this nightmarish roller coaster of emotions and with George; they were living out the most painful experience of their lives. During this heart wrenching ordeal, Angela's aunt called to tell her that she had dreamt of Angela's deceased younger sister. In the dream, her sister was in heaven, holding and caring for George and Angela's baby. Her aunt also told her "not all angels are born in heaven." George and Angela made the very painful and personal decision to send this Angel back to God’s loving embrace by terminating the pregnancy. In July of 2012, she had a partial hysterectomy. Since that surgery, her other side effects have subsided. It was confirmed that she was fully occluded at the time of the hysterectomy and her coils never migrated.
Angela hopes that sharing this story will somehow make a difference. Maybe her story will stop someone from getting Essure or it may enlighten women who are pregnant to the risks this device poses to an unborn child. There are women who have given birth to babies, e-babies, conceived while they had Essure. These babies may already have or may develop health issues that have not yet been connected to Essure.
I'm going to end this blog by quoting something Angela recently typed on our Essure Problems Facebook Group, "if we E survivors can’t get justice for the circumstances forced upon us, then hopefully we can at least help someone else make a more informed decision. Maybe we can even save a life."
As one of the administrators of the Essure Problems support page, I have read countless stories of pain and suffering caused by this nightmare device. A few months ago, a young woman reached out to share her story with me privately. Outside of her immediate circle, I was the only person who knew of the pain caused to her and her family by Essure. I write this one knowing that no matter how hard I try, I can never come up with the words to express that pain that Angela has felt. Those words just don't exist.
In June of 2011, Angela gave birth to her third child. She and her husband decided that Angela would have the Essure procedure done as it was highly recommended by her doctor. She had the procedure done in September of 2011, and at the time, she didn't regret her decision to be sterilized. She knew her family was complete. Three months later, in December, the HSG was performed and this test showed that her tubes were occluded and she was sterile.
Angela noted that she started having side effects shortly after the devices were implanted. Like so many women, she is allergic to nickel and she was not aware that Essure coils are made of a nickel alloy. Some of her symptoms included heavier periods, night sweats, fainting, cramping and severe lower back pains which resemble the back pain that women experience when they are in labor. Staying awake for longer than a few hours became a challenge and she felt like she was living in a drug induced state. Angela had three children, the youngest of which was not even a year old, and the issues with her health were impacting her ability to be a mom.
In April of 2012, Angela took a home pregnancy test. She didn't expect it to be positive as her doctor assured her that she could NOT get pregnant on Essure, especially after her HSG confirmed her fallopian tubes were blocked. The results of that home pregnancy test were positive. If that test was correct, she was now pregnant with her fourth child. Her doctor’s office refused to believe that Essure had failed and she was pregnant. A rep for Essure had even told her doctor that pregnancies with Essure are only the result of errors committed by the physician. Her doctor performed a blood test and this also showed she was pregnant.
Angela was told it was likely the pregnancy would be ectopic or end in a miscarriage due to the Essure devices. She thought this was a case as she was having significant cramping and spotting. Her doctor’s office performed an ultrasound and they shared with Angela that the gestational sac was about 4 times larger than normal, indicative of a pre miscarry situation. For the next several days, Angela lived with the symptoms of what she thought was a miscarriage. She and her husband struggled to come to terms with this sad loss. This, after the shock of finding out they were pregnant in the 1st place. Two weeks later, Angela was told by her doctor that she had not miscarried and that the pregnancy was progressing. This was just one of many moments on the emotional roller coaster for George and Angela. They had experienced the complete shock & then acceptance of an unplanned pregnancy, had decided to embrace the situation as they decided (along with the doctor) that it was a miracle baby. Then, they had mourned the impending loss of the miracle, only to have renewed joy when they learned the baby wasn't lost.
Angela's doctor was still very concerned about the baby. The enlarged gestational sac simply wasn't normal and he referred her to a gestational specialist. Over two separate visits, tests revealed the most heartbreaking scenario. The specialist determined that the baby was not developing properly. A diagnosis of extreme radial dysplasia or radial clubbing was shared with Angela and George. The doctor described the case as one of, if not the most, extreme he had seen. At first, they were told it was only on one side of the upper body, then it became both sides, and then it became club foot as well. The miracle baby was severely deformed. Sadly, they also learned that children with radial conditions generally experience other potentially life threatening disorders including cardiac and renal conditions. There were also strong concerns that neurological disorders may be present.
Angela started to research what may have caused this condition as she was assured that it was not genetic, and her 3 other children were all healthy. The only difference in this pregnancy was the presence of Essure. Angela discovered that Radial Clubbing is most often caused by exposure to a carcinogen during the first seven weeks of pregnancy. Essure is made out of nickel, which is a carcinogen. Angela lives in Texas and had no other environmental factors which would have contributed to this condition.
The news that was shared with George and Angela about the health issues impacting the baby were not shared in one visit. It happened over the course of several closely spaced visits. Each time they saw their doctor, it just got worse and worse. For this baby to have any chance at a somewhat normal life, multiple surgeries would have been necessary as soon as the baby was born, and that is only if the baby was able to be carried to term, and survived outside the womb. Normalcy for this baby would include a life bound to a wheelchair, as well as the necessity of other medical support devices. Again, that is if this baby survived outside the womb. Sadly, the odds were against this happening. With the doctor’s prognosis, George & Angela had to consider what would happen to the quality of life for their three existing children as well as the quality of life for the unborn baby.
Angela is riding this nightmarish roller coaster of emotions and with George; they were living out the most painful experience of their lives. During this heart wrenching ordeal, Angela's aunt called to tell her that she had dreamt of Angela's deceased younger sister. In the dream, her sister was in heaven, holding and caring for George and Angela's baby. Her aunt also told her "not all angels are born in heaven." George and Angela made the very painful and personal decision to send this Angel back to God’s loving embrace by terminating the pregnancy. In July of 2012, she had a partial hysterectomy. Since that surgery, her other side effects have subsided. It was confirmed that she was fully occluded at the time of the hysterectomy and her coils never migrated.
Angela hopes that sharing this story will somehow make a difference. Maybe her story will stop someone from getting Essure or it may enlighten women who are pregnant to the risks this device poses to an unborn child. There are women who have given birth to babies, e-babies, conceived while they had Essure. These babies may already have or may develop health issues that have not yet been connected to Essure.
I'm going to end this blog by quoting something Angela recently typed on our Essure Problems Facebook Group, "if we E survivors can’t get justice for the circumstances forced upon us, then hopefully we can at least help someone else make a more informed decision. Maybe we can even save a life."
Wednesday, September 25, 2013
Labor with Essure - Life Altering
Hello,
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.
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
Hello,
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:
Chair
Dr. Thommaso Falcone
Professor and Chairman of Obstetrics & Gynecology
Cleveland Clinic Foundation
Cleveland, OH
Dr. Ann J. Davis
Professor
Dartmouth Medical School
Hanover, NH
Dr. Frank W. Ling
Obstetrics and Gynecology
Obstetrician
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?
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:
Chair
Dr. Thommaso Falcone
Professor and Chairman of Obstetrics & Gynecology
Cleveland Clinic Foundation
Cleveland, OH
Dr. Ann J. Davis
Professor
Dartmouth Medical School
Hanover, NH
Dr. Frank W. Ling
Obstetrics and Gynecology
Obstetrician
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?
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