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‘I’m rotting from the inside out’: woman tells of vaginal implant gone wrong
Sep 5, 2015 | The Courier Mail
By Rhian Deutrom
A BRISBANE woman whose body rejected a controversial pelvic implant at the centre of a class action has spent the past decade in agony. -
The Low-Down on Vaginal Mesh for Prolapse
Sep 4, 2015 | Everyday Health
By Emily Willlingham
It happened to a queen of England, and it will happen to as many as 50 percent of women over the age of 40 today: pelvic or vaginal prolapse, a condition in which the muscles of the pelvic floor weaken so much that they no longer support the organs resting on them -
Media Coverage Leaves Tainted Impression of Mesh Injury Surgeries and Medical Lien Companies
Sep 3, 2015 | Mehs Meidcal Device News Desk
By Jane Akre
A recent series of Reuter’s articles takes a broad swipe at the industries that helps women find the resources they need to obtain mesh-removal surgeries. -
Women Revolt Against The FDA
Sep 6, 2015 | Vocativ
By Tracy Clark-Flory and Leigh Cuen
The Essure activists will be joined during the meeting by activists fighting the FDA over two other women’s health issues: transvaginal mesh and power morcellators.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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‘I’m rotting from the inside out’: woman tells of vaginal implant gone wrong
Sep 5, 2015 | The Courier Mail
By Rhian Deutrom
A BRISBANE woman whose body rejected a controversial pelvic implant at the centre of a class action has spent the past decade in agony.
Dee Nelson, 46, has been fighting for specialists around the country to address severe complications caused by a common vaginal implant.
While the mother-of-two looks perfectly healthy, she believes the tension-free vaginal tape sling, distributed by Johnson & Johnson Australia, is slowly killing her
Ms Nelson received the implant in 2005 for weak pelvic muscles following the birth of her daughter. Two weeks later, she was rushed to the emergency department with heavy bleeding and a high fever.
According to Ms Nelson, her body rejected the implant but no one would believe her. Doctors told the mother her symptoms were “all in her head”, and at one point, a psychiatric assessment was suggested.“I have a beautiful partner ... but I can’t love him and he can’t love me,” Ms Nelson said.
“I knew what the problem was, as did millions of other women across the world, but no one would listen,” Ms Nelson said.
“These people were playing with my life, but if I went back and said there was something wrong, they just wiped their hands of me.
“I have been handed around the system from one specialist to another, and in the meantime, women are dying from these foreign objects inside them.”
For the next 10 years, Ms Nelson’s health rapidly deteriorated as her nerves and muscles grew through the plastic implant, wreaking havoc with her confidence.
“I have aged so much, and I’m in constant pain,” she said.
“I can’t hold down a job, eat during the day or stand up for long periods … I feel like I’m 90 years old. It’s horrific.”
Surgeons around the country have refused to remove her implant as it has been inside her for too long.
Ms Nelson said the side effects have taken a significant toll on her family as well.
“When my children were young and needed me, I couldn’t be there for them because I was in agony,” she said.
“They have had to watch me deteriorate … it’s devastating.”Dee Nelson before receiving the tension-free vaginal tape sling.
For Ms Nelson, even the thought of having sex with her husband was painful.And Ms Nelson afterwards: “I’ve aged so much.” Picture: Tara Croser
For Ms Nelson, even the thought of having sex with her husband was painful.
“I have a beautiful partner who I have been married to since I was 16 years old, but I can’t love him and he can’t love me,” she said.
“To go through life without love and not be a woman isn’t right.”
Ms Nelson is one of about 40,000 Australian women who received mesh implants before they were withdrawn from sale in 2012. Shine Lawyers’ class actions solicitor Bridget Cook toldThe Courier-Mail a lawsuit was filed against distributor Johnson & Johnson Australia and manufacturer Ethicon in 2012 on behalf of 400 women who suffered the devastating side effects.
“We allege the products were introduced without any pre-market testing … the implants were not fit for their purpose,” Ms Cook said.
A spokeswoman for Johnson & Johnson Australia said the company was “always concerned when a patient experiences adverse medical events”.
She said Ethicon is “vigorously defending” all lawsuits concerning the allegedly faulty implants.
“We are confident the evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of its pelvic mesh product s.
“We have made patient safety a top priority, and will continue to do so,” the spokeswoman said.
While the lawsuit inches closer to a trial, Ms Nelson remains housebound, praying to regain control of her life. Her only hope is to travel to the US to undergo $40,000 surgery to finally have the mesh removed.
“Knowing what I know now, I would never have gone through with it … It’s rotting me from the inside out,” she said.
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The Low-Down on Vaginal Mesh for Prolapse
Sep 4, 2015 | Everyday Health
By Emily Willlingham
It happened to a queen of England, and it will happen to as many as 50 percent of women over the age of 40 today: pelvic or vaginal prolapse, a condition in which the muscles of the pelvic floor weaken so much that they no longer support the organs resting on them. After Queen Victoria’s death, her physician found that she had a prolapsed uterus, which isn’t too surprising considering that the famously fertile queen was the mother of nine children.
“The primary risk factor is childbirth,” says Steve Abramowitch, PhD, assistant professor of bioengineering and obstetrics, gynecology, and reproductive sciences at the University of Pittsburgh. “While most women will not prolapse, the ones who will usually have had one, two, or more children.” He says that vaginal birth bumps up a woman’s risk by four times with the first child. That risk goes up 11 fold by the third vaginal birth.
Other risk factors for pelvic prolapse are obesity and a history of constipation, says Dr. Abramowitch. While lifestyle interventions might help with those, we can’t do much about one of the risks: our genetics.
“You can’t choose your parents, and part of it is genetic,” says Lauren Streicher, MD, associate clinical professor of obstetrics and gynecology at Northwestern University’s Feinberg School of Medicine and Everyday Health columnist. She says that some women even go so far as to try to ask for a cesarean section with their first pregnancies because of a family history of pelvic prolapse. But for women considering a cesarean after they’ve already given birth vaginally? “Don’t bother," she says. "The damage is already done with the first baby.”
One thing any woman can change about her risk for prolapse, says Dr. Streicher, is smoking. “You can’t control baby size and genetics,” she says, “but you can control smoking, and that’s going to be a huge factor.” Although the reasons are not clear, large studies have shown smoking is one of the risk factors, and one we can modify, notes the University of Texas Southwestern Medical Center in Dallas.
For many women, a vaginal delivery is already part of their history. For those who go on to develop prolapse, what can they do?Support for Women’s Organs After a Prolapse
A temporary, nonsurgical measure is a pessary, a plug that can be inserted into the vagina to keep the prolapsed organs supported. “Some women have success with that, but many patients become a little frustrated with it, because it requires constant insertion and cleaning and it can start to wear against the vaginal wall,” says Abramowitch. But for many patients, this measure is a bridge to having a surgical intervention.
And that’s where the choices become a little tough. One method to keep the organs where they belong is to implant a support that will hold up the organs against the pull of gravity. The two options women have are a synthetic mesh or a repair using their own tissues. Each option carries its own risks, as the legal and medical dramas unfolding around the meshes illustrate.Pros and Cons of Synthetic Mesh
“The main reason the meshes started to become popular was because many of the native tissue repairs were failing,” says Abramowitch. Tissue repairs of prolapse failed as often as 40 percent of the time, he adds, so that women often had to return for a second surgery. Sometimes, that second surgery isn’t a possibility because the tissue is just too fragile to use for support.
But the meshes, while sturdier, carry the possibility of complications, as with any medical intervention. Abramowitch says reports of mesh complication rates vary. While certain studies suggest a complication rate as high as 30 percent, studies that he characterizes as “better” set the complication rates at 10 to 15 percent. “It’s been a success for a large number of patients,” Abramowitch says. “Unfortunately, with the litigations, it’s scaring patients into believing that mesh is not a viable option now.”Prolapsed Bladder: A Patient’s Experience With Mesh
One patient who did decide to go ahead with the mesh is 73-year-old Kathryn S. of Stanhope, New Jersey. Kathryn discovered her condition one day while she was in the bathroom. “I remember going, ‘where did this come from?’” she recalls about finding her prolapsed bladder. “I don’t know how to describe it — it was like a little head, it was really soft, and you could push it back up.”
Kathryn started treatment for her prolapse with a pessary while she investigated her other options. She read medical reports online about the procedure and determined that many of the drawbacks were linked to how the device was inserted by the surgeon.
After doing her research, Kathryn decided to go with the transvaginal mesh implant. At a few weeks after her procedure, except for a little expected fatigue, she says, “my experience is all positive.”
She thinks that many women may have her condition but don’t want to talk about it, much less seek help for it. “A woman I work with, she called me the other day,” she relates, “and she said, ‘I get that, too, and I just push it back up.’”
Kathryn turned to Michael Ingber, MD, a urologist at Morristown Medical Center in New Jersey, for her procedure. Ingber specializes in pelvic surgeries, and Kathryn chose him because of his extensive experience.
RELATED: Fitness for Your Pelvic Floor, not Just Your Abs
Streicher says that when a woman does decide to go the surgery route, seeking clinicians with the right experience is critical. “People really don’t understand that there are plenty of doctors out there who are truly not experienced in the things they say they are,” she says.
What a patient needs to know isn’t a specific number of procedures performed but how routinely a surgeon does the work. “You want to hear ‘I do them every week,’” Streicher says. “Don’t be afraid of offending a doctor by asking about or questioning their experience,” she adds.Pelvic Mesh Procedures
Two procedures are possible when using mesh to address prolapse, says Dr. Ingber. One involves going through the abdomen, and the other involves implanting the mesh vaginally. The choice of which route to go depends on individual patient factors.
“Every patient is different,” he says. “In a young, sexually active woman who’s maybe 40 years old who’s had a bladder or uterine prolapse, the better procedure is to go in through the abdomen.” For women over age 70, who have a different anatomy and might not be as sexually active, the vaginal route might be preferable because it’s a faster surgery with a quicker recovery.
Kathryn’s surgeon, Ingber, is one of the investigators in a post-marketing surveillance study for a mesh that is currently on the market. These studies are designed to track patients using these marketed products as a way to keep tabs on emergent problems. Kathryn finds her recovery manageable so far. “I think the mesh is a great thing,” she says. “I feel like me, which I haven’t felt like since I discovered that thing trying to come out.”
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Media Coverage Leaves Tainted Impression of Mesh Injury Surgeries and Medical Lien Companies
Sep 3, 2015 | Mehs Meidcal Device News Desk
By Jane Akre
A recent series of Reuter’s articles takes a broad swipe at the industries that helps women find the resources they need to obtain mesh-removal surgeries.
With 100,000 plaintiffs now joined in litigation against seven mesh manufacturers, removal of the polypropylene mesh implant may be the only avenue to find some relief for those disabled by the permanent medical device, used to treat incontinence and prolapse.
As a result of “The Lien Machine,” HERE many women may be scared off from seeking and funding the surgeries they desperately need now, rather than later when their case settles if it ever does.
Knowing what questions to ask is an important tool for women who need surgery. Most mesh injuries do not improve over time, in fact, they often get worse, leaving a woman to suffer.
The following is intended to offer some clarity to this story for those who may seek medical management of their mesh cases to make the road an easier one. (Disclosure- no surgical lending or debt buying firm is a supporter of Mesh News Desk).
Drawing courtesy of JadeR.
CASH ADVANCE OR DEBT PURCHASE
There are two ways to obtain financial help to fund your mesh removal surgery when private insurance does not. A recent story on MND on Lawsuit Financial LLC, (one-time supporter of this site) provides consumers with guidance on how to borrow conservatively. These cash advances, used to finance surgery or pay a lapsed mortgage, accrue interest, just like a credit card over time, and therefore can become very expensive.
Dollar sign Scott Steiner, WikiCommons
See What You Need to Know Before You Borrow” HERE.
The cash advance company places an uncollateralized lien on her eventual settlement or jury award. It is expensive money because there is no assurance it will ever be repaid. The percentages accrue over time.Another vehicle to fund mesh-removal surgery is provided byMedStar, an Austin-Texas-based company that was the focus of the unflattering Reuters reports. In this type of assistance,MedStar, known as a factoring company, buys the discounted medical debt counting on it to eventually be paid by placing a lien on a plaintiff’s settlement or a jury award.
The medical provider determine the debt. There is no interest accruing. It is not unlike the exchanges between banks offering home mortgages. Your bank may sell your mortgage to another lender to collect. It does not change what you owe on your home. The downside- the cost is often not discounted to the extent it would be for an insurer, Medicare or Medicaid. That is disclosed up front in the fine print.Bottom Line- Eventually the woman will be expected to pay for her surgery from the settlement money is she is receives or is awarded by a jury. If there is no settlement or award, the bill will be excused by a cash advance company. It may be adjusted or reduced by a factoring company though she is technically on the hook to pay that debt.
WHAT SHOULD A PELVIC MESH REMOVAL SURGERY COST?
In the OR, Miklos and Moore
The fundamental problems with the Reuters story is it cites insurance reimbursement as indicative of the relative value of a mesh surgery. The insurance industry is slow to catch up with the realities of mesh complications, called by removal surgeon Dr. Veronikis, one of the “darkest chapters in women’s health.”
The Reuters report accuses the surgeon in the story of charging an “inflated bill,” however, without knowing the cost of a surgery, it’s difficult to accuse someone of overcharging.
So what should a pelvic mesh removal surgery cost?
First, it can take anywhere from 20 minutes (partial removal in the office setting usually) to a 4, 5 or 6 hour difficult surgery maneuvering around pudendal nerves, scar tissue, mesh fragments, bladder, urethra, mesh arms, etc.- in other words, a challenge not fit for an amateur.
Dan Christensen, MedStar Funding LLC
Dan Christensen of MedStar concurs; there is no standard sticker price for a mesh surgery.
“The surgeries come in all shapes and sizes, all done by different doctors in different geographical areas with different levels of experience. It may depend where they practice and their level of expertise. You will see widely differing costs of surgeries also because the surgeon doesn’t know what they are going to encounter.”
In questioning readers what their surgeries cost,Mesh News Desk got the following answers:
One woman from the Midwest said her bill tallied $14,188; another from Canada has been quoted $39,800 by the hospital. That number does not include travel from another country or accommodations. A woman from Florida says her surgery and three-night hospital stay was $76,894.63.
Those numbers may or may not include the cost of a consult ($1,000) the translabial ultrasound ($1,000), or the urodynamics test (upward of 5,000 to 8,000).
Another woman from New Zealand raised $100,000 to cover the cost of travel to the States to have her mesh removed.
Meanwhile insurance reimburses as little as $350 to $1,600 at UCLA, according to Dr. Shlomo Raz, a leading mesh removal surgeon at UCLA.
Because insurance reimburses so little, many doctors say they are not being adequately compensated for their skill-set or time and do not want anything to do with removal or excision surgeries, not to mention the potential liability.
The doctor in the Reuters story charged $17,000 for a mesh removal surgery, which is in line with the findings of our unscientific survey but again, the reporters used the anemic insurance reimbursement as a standard to declare it an “inflated bill.”
Adding concierge care, that is, book hotels, arranging flights, covering the cost of an OR, thousands more can easily be added to the bill you’re expected to pay.Bottom Line- Comparing an insurance reimbursement to the actual cost of a surgery is inaccurate and minimizes the severity of these injuries and surgeries needed to correct complications. Insurance companies and the government receive a discount. In the case of a factoring company, the discount essentially benefits the company purchasing the debt. That’s how they’re paid.Know what you are buying and what it will cost. Like any purchase- get it in writing. Get the surgical estimate in writing as well. The patient, doctor and lawyer should all have a good idea what the surgery will cost after a medical assessment by an experienced mesh-removal expert.
WHO IS EXPECTED TO PAY THE BILL?
Every time we see a doctor, we are promising to pay the full amount of the charges. A trip to the emergency room and often the first question is – ‘Who will pay the bill?’ Despite the fact you are bleeding, you often must first sign a paper agreeing to pay the charges.
In the case of a factoring company, the company buys the debt (the medical bill) and becomes the assignee that expects to be paid, whenever. The win-win is the doctor is paid immediately instead of waiting years to receive payment. The bill is dictated by the medical care she provides and according to MedStar it must be, “usual, customary and reasonable.” In other words, not inflated.
Rick Tadrick, National Director of Business Development for Medfin, another factoring company says in practical terms, if the lawsuit fails, the medical provider and/or the funder is not going to be able to collect anything.
“If it’s diminish value did not reach the threshold we did not estimate it to be, MedFin will sit down with attorney and have to discuss some aspect of a reduction. Everyone participates in the pain of a case that does not meet the threshold we anticipated in recovery.”
Tadrick adds he may not work with that attorney again.Bottom line– That’s why it is so important a mesh-injured woman has an accurate assessment from a mesh-removal expert, not a doctor who is unfamiliar with mesh complications. The latter may devalue the case. The former not only makes it easier to obtain funding but eventually it will reflect the actual value of her case when it comes time to settle.
IS THE PATIENT TOLD WHAT THAT SURGERY WILL COST?There should be no surprises. After a medical workup, the patient and lawyer consult with the doctor to determine an estimated cost of the surgery.
Absolutely, says Christensen of MedStar.
“We inform the patient and the lawyer what the expected charges will be before the procedures are done. If the patient or her attorney feel the charges are too high, they can elect to shop around to other providers. To say someone doesn’t know it was going to be that much in the end means she didn’t read the documents.”
As far as the need to obtain surgery, it could be construed as malpractice if a lawyer knows of a way to a client to receive aid and they neglect or refuse to inform the client of that solution.
Christensen says as far as MedStar, there is no “referral fee” or “kickback” for the lawyer who contacts them.
For her part, the only patient quoted in “The Lien Machine,” said she was not adequately informed about the costs. MND asked Traci Rizzo if she received paperwork and estimates in advance of her surgery.
“No comment lol” she said via email.Bottom line– If a middleman provides you “concierge services” such as travel, hotel airfare, expect that will increase your bill as well. Get an estimate in writing. Read the fine print which appears in Rizzo’s contract. “PATIENT further acknowledges that medical providers typically receive more for their services when paid by contractual arrangements, such as this, than if they were paid by health insurance companies, government programs such as Medicare or Medicaid, or by the patient in cash.”
Doctors, WikiCommons, Olga
ARE MIDDLEMEN OPERATING IN THE SHADOWS?A Mesh News Desk story HERE originally reported in October 2013, may have been the basis for theReuters story.
The allegations of a “scheme” to profit from transvaginal mesh injuries were made by American Medical System after it was tipped off by one of their consultant/doctors. It refers to middlemen who work in the shadows as brokers. AMS deposed the participants last year though there has since been no follow-up.
Dan Christensen, owner of MedStar, is also an attorney, therefore is required to be an officer of the court. He says AMS alleged the doctor was told to falsify information in a medical report to increase the value of cases. He says that was a misunderstanding.
“I would never be involved with someone who would do something like that. All anyone saying is whatever you do or don’t do or observe, on these cases you need to document everything! Treatment notes could be a few lines of chicken scratch and that’s it. That may suffice in a managed care case being submitted to Blue Cross. When you talk about litigation, it’s important to document everything he sees or does.”
In the case of TVM (transvaginal mesh) litigation, MSO’s (Medical Service Organizations) typically are the middlemen that assist in coordinating care.
Christensen gives an example of how an MSO works.
“Take a surgical facility. It’s empty Saturday morning. The MSO will say ‘I can fill it where it will otherwise go empty and I will pay you x-dollars whether I use it or not. The facility will say yes. Now this MSO says I will buy that block of time at this rate. Through those relationships, the MSO can negotiate good pricing and guarantee payments to make the medical providers comfortable about doing these surgeries. “
Mesh News Desk has reported on another type of middle man – lead generators who solicit clients to sign up for litigation, whether or not they are injured. How they obtain your name and number is a mystery. Your editor was even called by one that promised I might be able to recoup dollars by joining in litigation. See the story of “Patrick” HERE.Bottom Line- Hang up if someone is trying to solicit you over the telephone. A mesh-injured woman should seek a qualified law firm, preferable one that specializes in cases naming her mesh manufacturer. See the Southern District of West Virginia, HERE, a federal court in Charleston, where 80,000 mesh cases are consolidated. Click on your manufacturer then on your mesh maker and in the fine print above see which law firms are taking these cases to trial (See Steering committees, Lead and Liaison Counsel).
CAN A WOMAN WALK AWAY WITH NOTHING?
If a woman receives a settlement that doesn’t cover the cost of her medical bills, she can simply refuse it. Her lawyer will not be happy. He or she is paid only when the plaintiff agrees to accept the settlement offer and some law firms have spend a million dollars or more to bring one plaintiff to trial. Medicare will get nothing and neither will the doctor.
In that case, MedStar’s Christensen says the companies will put their heads together and come up with a compromised amount and try to get something in her pocket.
Another factoring company that buys medical bills is Arizona-based MedFin. Rick Tadrick, National Director of Business Development for MedFin says that is why it’s so important a realistic medical assessment of her injuries be done before the surgery is performed.
“Miklos and Moore may say she is not surgical; They will not do one simply to do one. No doctor will. Any of these others, I don’t believe they will do one to bump up a case either.”
If she qualifies for surgery, Tadrick will more likely buy that debt after a review with her attorney to make sure it is a solid case.Bottom Line – If your case offers a disappointing settlement, most companies will work with you and your attorney to make sure the woman has something. If a jury does not award anything on a case, the debt may be excused completely, even though technically you are still obligated to pay.
HOW THIS ARTICLE MIGHT HURT THE MESH-INJURED PLAINTIFFS
Scales of Justice, WikiCommons
The fundamental problems with “The Lien Machine” is it cites insurance reimbursement as the relative value of a mesh surgery. In the process it diminishes the seriousness of a mesh-injury and the degree of complication involved in removing an implanted medical device that was intended to be permanent, though never tested on humans before being marketed.
Mesh News Desk has interviewed many doctors who complain that insurance reimbursement rates are an insult to those already hurt by the medical profession and mesh makers. Unless they receive a salary, many opt to do the mesh explants only if insurance is not involved.
Christensen defends MedStar and the way it does business.
“The procedures we have in place I am completely satisfied with in that we do notify what the expected charges are. We have no control over the charges, they are dictated by the medical provider. Unfortunately they are trying to characterize MedStar is trying to take advantage or gouging these patient but that’s not the truth,” he tells Mesh News Desk.
Reuters takes a swipe at trial attorneys as well. In a follow-up story, it asked the American Tort Reform Association (ATRA) to weigh in on trial lawyers and medical funders. ATRA is behind the tort reform movement and funded by the very big industries, asbestos, tobacco that attorneys take to trial.
Christensen is concerned that the story is being repeated on the internet and held up as an authoritative piece of journalism when in fact, no one from Reuters talked to him or anyone from his company before writing, “The Lien Machine.”
How then as he quoted for the article? Christensen’s comments were taken from his deposition with AMS last year, he says, therefore were out of context.
He has a point. The Society of Professional Journalists (SPJ) Code of Ethics makes it clear – Give the focus of your story an opportunity to answer all criticisms. It says “Diligently seek subjects of news coverage to allow them to respond to criticism or allegations of wrongdoing.”
See the code HERE.
“Clearly these journalists had an agenda. What could be the net effect is funding entities decide they don’t want anything to do with mass tort clients because of the target they could become if they are trying to help.
“The market needs to be informed, not incited,” he says. #
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Sep 6, 2015 | Vocativ
By Tracy Clark-Flory and Leigh Cuen
Later this month, 35-year-old Angela Desa-Lynch plans to go camping—at the Food and Drug Administration. She will pitch a tent and roll out a sleeping bag in front of the FDA’s Washington D.C. headquarters, along with a couple dozen other pillow-toting friends. There, they will be conducting a hunger strike. The goal is to get the agency to remove from the market Essure, a medical device that they believe is hurting and even killing women.
“We’re just gonna stay there,” she says. “After five days is over, we’ll give them a couple months, and if they don’t pull Essure from the market, then we’re coming back and we’ll do it again.”
Essure is a metal spring that is inserted into each fallopian tube. It causes scar tissue to grow, which eventually blocks the entrance of sperm or movement of the egg. It’s the only permanent non-surgical birth control option approved by the FDA and as such it has been heralded as a major breakthrough for women’s reproductive healthcare.
Not everyone sees it that way. Desa-Lynch is one of nearly 20,000 women who belong to the Facebook group “Essure Problems.” The majority of its members have or used to have Essure and claim that it caused them a host of debilitating medical problems, ranging from hair loss to swollen abdomens to perforated fallopian tubes. They also question the device’s claim of 99.83 percent effectiveness at preventing pregnancy; Desa-Lynch says there have been around 600 pregnancies among group members with Essure. (This number, which would put the device’s effectiveness at about 97 percent, may be high due to the self-selecting nature of the group. Or it may actually be low: Dr. Aileen Gariepy, an assistant professor of obstetrics, gynecology and reproductive sciences at the Yale School of Medicine, has calculated that one in 10 women who’ve had Essure implanted would become pregnant over 10 years, according to The New York Times.)
It’s a tight-knit, highly active community with its own particular language. Throughout the day, they commiserate with their “e-sisters” about their “e-hell” and all the “e-motions” that come along with it. They share before and after photos of their “e-bellies.” They post about their “e-viction” dates once surgery has been scheduled and post “e-free” updates after the fact. Then there are the “e-babies” that they say were conceived despite Essure—and with them stories of miscarriages, abortions, birth defects and newborn death.
Recently, a peer-reviewed study recruited more than 1,000 women from the Essure Problems Facebook group to try out an app for reporting “adverse events” to the FDA. Nearly 78 percent reported “serious events,” including hospitalization and disability. The most frequent reported experiences were fatigue, back pain, pelvic pain, mental impairment, “device dislocation,” meaning the coil moved from its intended place in the fallopian tube, and salpingectomy, the surgical removal of the fallopian tube. Also of note: lost libido, metal allergies (the coils contain nickel) and hair loss. The researchers also found suicidal ideation among 14 of the women and two suicide attempts. (A long-term study of Essure recently reported that 99 percent of participants evaluated their comfort with the device as “good” to “excellent.” Most “adverse events” reported by the participants were rated as “mild” or “moderate.” Three “severe” events were reported—abdominal pain with heavy periods and irregular menstruation—in only two participants.)
The FDA, which has received 5,093 reports related to Essure, has noted some similar findings. The most frequent complaints were pain, heavier or irregular periods, headaches, fatigue and weight change. The agency has also received 11 reports of deaths related to Essure: five of fetal demise and six relating to four adult deaths.
Dr. Shawn Tassone, an OB-GYN in Austin, Texas, performed hundreds of Essure procedures before he stopped in 2013. That was thanks to a call he received from a doctor in another state about a former Essure patient of his—she had moved and was in the E.R. with an ectopic pregnancy. “I started thinking, doctors don’t usually call each other and say, ‘I saw your patient,’ so it struck a nerve that maybe there’s more people out there that had more complications like this.” That’s when he discovered the Essure Problems Facebook group. Now, Tassone, who has accompanied the Essure activists to a past meeting with the FDA, only performs procedures to remove the device. “I’m seeing some pretty crazy things: distended abdomens that are gone in a few days to weeks, rashes that are disappearing, pain that’s getting better. It’s really interesting.”
That isn’t to say that he believes all of the symptoms and experiences described in the Essure Problems group can be necessarily attributed to the device. But he does believe that Essure can cause adverse effects in a minority of patients and that there should be a better way of removing it from women who are experiencing problems. “The only safe way to take out these Essures is hysterectomy,” he says, explaining that coils can easily break into pieces during removal, “and that’s a major problem.”
Desa-Lynch, a single mom, underwent the Essure procedure in 2008 shortly after having her third child. Not too long after, “little things started happening,” she says—night sweats, depression and migraines, for starters. At first, she says, “I chalked it up as, ‘Well, I just had a baby and now I got fixed and my body’s going nuts—so, hormones.’” But the symptoms kept coming, and getting worse: hair loss, jaundice, weight gain, fatigue. “I hurt so bad I couldn’t get out of bed,” she says. “I just felt like, ‘I’m dying. I don’t know what this is, but it’s killing me.'” That’s when she began investigating her symptoms online and found the Essure Problems group.
In 2012, she decided to have the Essure coils taken out. At the time, the only way to do that was a hysterectomy. “By the time I had surgery, my biggest fear was that I wasn’t going to live through the surgery, ‘cause I was so weak,” she says. “I could barely get out of bed.” Just a few days after the hysterectomy, she says, she already felt better.
The camp-out and hunger strike will begin on September 24, immediately after a scheduled FDA panel meeting featuring anti-Essure activists as well as representatives from Bayer, the device’s maker. That is because, while the agency has agreed to hear their concerns and consider their evidence, spokespeople have publicly clarified that the FDA is not considering reversing approval for the device. “That was just it for me,” says Desa-Lynch, who came up with the idea for the hunger strike. “I was like, ‘I’m not leaving until something is done.'”
An FDA spokesperson told Vocativ that the agency is “seeking input from the panel concerning the safety and effectiveness of Essure.”
The Essure activists will be joined during the meeting by activists fighting the FDA over two other women’s health issues: transvaginal mesh and power morcellators. The first is used to treat pelvic organ prolapse, a condition in which organs bulge into the vagina, and that has been linked to conditions including chronic pain and fatigue. The latter is a surgical tool used to cut up uterine tissue for removal through a small incision, and activists argue—and the FDA has acknowledged—that it can spread previously unrecognized cancerous tissue outside of the uterus, upstaging the cancer and decreasing a patient’s likelihood of survival.
These causes have joined together in part because there is overlap between them all. Desa-Lynch points to the similarity of symptoms between the “e-sisters” and “mesh girls,” as she calls them. Essure Problems also has several women who have undergone the sterilization procedure and then, after experiencing what they believed to be negative side-effects, had the coils and their uterus removed via morcellation. At least one member has undergone all three procedures.
Desa-Lynch also argues that they have sexism in common. “In any one of those three different fights, a woman goes to the doctor and tells them what their problem is, we’re automatically written off as hormonal. We’re not listened to,” she says. “If this was happening to a man, if they had made this product for a man and 20,000 men came out and said, ‘We can no longer have sex anymore,’ I guarantee it would no longer be on the market.”
Tassone questions the cultural norms that drive women to procedures like Essure, when there are better alternatives available for men. “I think you guys get shafted on this whole—well, kind of in general—but definitely in reproductive stuff,” he says. “It’s all your responsibility to not have babies, right? The one time that a guy can actually do something is a vasectomy and nobody does that, hardly!” Tassone always tells his female patients that the best permanent method of birth control is for their male partner to have a vasectomy, a much safer and easier procedure than the equivalent surgery for a woman. “Ninety percent of time they say, ‘Well, that’s not going to happen,'” he says. Many men believe that a vasectomy will hurt their manhood, and plenty are simply accustomed to seeing birth control as a woman’s responsibility.
“We’ve always put the burden on the women,” he says, “but we also minimize them when they have complaints.” Promoted Stories
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