ESSURE – Approved – 2002; Black Box – 2016; Off Market – 2019; Damaged Patients – Forever

“Essure is a permanent sterilization device intended for women who have decided against any, or any more, pregnancies. The aim of the permanent implant is to trigger tissue growth that blocks the fallopian tubes and prevents sperm from entering the ducts.” ( “Conceptus Inc., a subsidiary of Bayer AG, developed Essure which is a Class III device for permanent surgical sterilization in women. Essure was approved by the Food and Drug Administration (FDA) on November 4, 2002. The device has two metal coils made from polyester fibers, nickel-titanium, stainless steel, and solder which are placed in fallopian tubes to induce fibrosis and block the fallopian tubes to prevent fertilization. Since 2002, it is estimated by Bayer that 750,000 women have received the Essure IUD.” (

“In an official posting, FDA Commissioner Dr. Scott Gottlieb said the FDA is working with Bayer to “revise and strengthen” its post-market study of Essure, which was ordered by the federal watchdog in 2016. The trial will now follow patients who received the Essure device for five years rather than the initially requested three years, giving the agency “longer-term information on adverse risks of the device, including issues that may lead women to have the device removed,” Gottlieb wrote in the posting.” ( “On April 9, 2018, FDA restricted the sale of Essure device to only those doctors and healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”. In July 2018, Bayer announced Essure would be wiped out of the market by December 31, 2018.” (

“There are also currently over 16,0000 lawsuits alleging harm caused by Essure. There are serious concerns regarding the approval process of the device along with the post-approval studies, and a current study ordered by the FDA. Patient activist groups, such as the Essure Problems Facebook group, have created platforms for support and education. Before making your decision, you should consult your doctor and make sure to ask a lot of questions, such as… Why are you recommending this product after Bayer has announced pulling it from the market? How many of these procedures have you done? Do you have a copy of the current patient checklist we are mandated to review and the black box warning we can discuss? What is your failure rate in placing Essure correctly in one attempt? Do you use general anesthesia to place Essure, or will I be awake the entire time? Have you ever removed essure? If so, how?” (

If you, a family member, a loved one, a friend, or anyone you know is experiencing problems with an Essure device, it may be time for you or that other person to contact a lawyer. There are statutes of limitations (deadlines), so waiting too long can mean no case. Paul J. Molinaro, M.D., J.D. offers free consultations on Essure cases for patients who reside in California.

18,000 Essure Lawsuits

As of February 2019, Bayer was facing about 18,000.00 Essure plaintiffs. ( “Plaintiffs claim that the manufacturer failed to inform patients and physicians of possible dangerous side effects. Some women have been forced to have additional operations in an attempt to correct complications that the device caused. Women’s organs have been perforated, devices have broken inside fallopian tubes, and many women have endured years of pain and suffering. Women are seeking several types of damages as a result of the pain and suffering from Essure, from compensatory damages for medical costs, to general damages for mental and emotional anguish. Consumers are also seeking punitive damages in order to punish Bayer for developing and selling a harmful product and to stop the company from making this negligent practice into a habit.” (

#essure #perforation #organperforation #brokendevice #fallopiantubes #painandsuffering #defectivemedicaldevice #bayer #conceptus #lawsuit #lawyer

Essure: No Longer Sold or distributed in U.S.

“Tens of thousands of women say they suffered painful and serious side-effects from Essure, a medical device meant as a permanent birth control option. The device is the subject of nearly 27,000 complaints to the FDA since its approval in 2002. Women reported excessive pain, severe allergic reactions and, in some cases, perforated organs.” ( “Essure will no longer be sold or distributed in the U.S. after December 31, 2018, a decision that was made by the manufacturer, Bayer, for business reasons. Health care providers can implant Essure for up to one year from the date the device was purchased.” ( “The Essure system is a type of permanent birth control for women. It cannot be reversed. This type of female sterilization involves placing small metal and fiber coils in the fallopian tubes, which creates scar tissue that prevents sperm from reaching an egg. During the procedure, the doctor inserts a flexible tube with a small camera (hysteroscope) through the vagina and cervix and up to the uterus. From here, the doctor can see the opening to the fallopian tubes and place the Essure system coils into them. It takes about three months for the Essure system to prevent pregnancy. In some women, it may take up to six months. During this time, you must use another form of birth control to prevent pregnancy. Essure doesn’t protect you against sexually transmitted infections (STIs). The company that manufactures Essure plans to stop production of this contraceptive device at the end of 2018.” (

Is the New Mesh Better than the Old Mesh?

“Scientists from the University of Sheffield have developed a material that could be used as an alternative to the current vaginal mesh material, polypropylene, used to treat pelvic organ prolapse and stress urinary incontinence.” ( Polyurethane possesses much more elasticity than polypropylene and is therefore better equipped to sustain the pelvic organs — the bladder, bowel and vagina — exerting pressure on the pelvic floor every day. ( “Polypropylene (PP) is a nonabsorbable polymer, used widely because of its high tensile strength compare to that of steel. PP is a linear aliphatic hydrocarbon with a methyl group attached to alternate carbon atoms on the chain backbone (-C3H6-). As a result, it is nonpolar in nature, highly hydrophobic, electrostatically neutral and resistant to biological degradation.” ( “The overriding benefit of a PP mesh, however, is that even with its propensity to incite infection; the infections often been treated themselves without the removal of mesh. Additionally, many of the risks associated with PP are being modulated by adjusting mesh weight and porosity to promote more or less tissue in-growths. Though obviously not an inert material, PP meshes are considered to be a stable material provides an adequate service to save life.” ( The comments are all recent… so, which do you believe?


More than 100,000 women have filed lawsuits against mesh manufacturers for their injuries, resulting in multimillion dollar verdicts and more than $1 billion in settlements. In 2011, the FDA reported receiving 4,000 adverse event reports caused by transvaginal mesh in the previous six years. In 2016, the FDA changed the classification of transvaginal mesh used to repair POP from a moderate-risk device to a high-risk device. The FDA orders apply only to transvaginal use of surgical mesh to treat POP, and not to the use of transvaginal mesh for SUI. ( “If you wish to find more information on transvaginal mesh, the FDA publishes information about transvaginal mesh and its risks on their website, and there are several transvaginal mesh patient advocacy groups as well as publications such as Public Citizen and Mesh Medical News Desk, which serve to educate the public about the risks of mesh and also information about safer alternatives.  ” (

Unsafe Mesh Was Marketed as Safe

Mesh Was Marketed as Safe: “Mesh material, used to treat pelvic organ prolapse and stress urinary incontinence, was marketed by its manufacturers as a durable surgical method for repairing these challenging problems compared to other corrective surgeries with a high failure rate.” ( “Early clinical trials suggested excellent efficacy and many surgeons saw advantages over traditional open-surgery procedures, which took longer to perform, involved a longer recovery for patients and were associated with their own range of complications. By contrast, a TVT procedure typically takes 3o minutes, is performed using keyhole surgery and patients often go home the same day. Meanwhile, the traditional treatments for pelvic organ prolapse, which included suturing to reconstruct and repair the affected organs and surrounding tissue, were proving less successful, with reports of up to 29%of women suffering another prolapse after treatment. Hysterectomy is another treatment option, which some women wish to avoid. “Because outcomes of using the mesh for incontinence and hernia were so good people were enthusiastic and confident it would also be good for prolapse,” said Christopher Maher, a urogynaecologist and associate professor at the University of Queensland. “That’s what the mindset was when it was introduced for prolapse around 2002.”” (

Mesh Was Used and Used a Lot: “Millions of women over the last two decades have undergone vaginal mesh surgery, but it has recently become clear just how many have experienced severe complications.” ( “About 300,000 women in the U.S. underwent surgery to repair POP in 2010. Surgical mesh was used in about one out of three procedures. About 250,000 women in the U.S. underwent surgery to repair SUI in 2010, with mesh placement being used in over 80% of the procedures.” (

Mesh Was Not Safe: “We estimated that 9.8% of patients undergoing surgical mesh insertion for SUI experience a complication peri-procedurally, within 30-days or within 5 years.” ( “Due to reports of complications during or after surgery for POP, in 2016 the FDA changed the classification of surgical mesh to repair POP transvaginally from a moderate-risk device to a high-risk device. The FDA orders apply only to transvaginal use of surgical mesh to treat POP. The orders don’t apply to the use of transvaginal mesh for SUI.” ( Vaginal mesh erosion “is the most common complication following the use of surgical mesh devices to repair pelvic organ prolapse and stress urinary incontinence. Non-absorbable synthetic surgical mesh, such as that made of polypropylene or polyester, can break down or wear away over time. Part of the mesh may become exposed or protrude through the vagina. ( Along with Scotland, the United Kingdom, and Australia, New Zealand had something to say about the so called safety of transvaginal mesh, even going to the point of effectively banning its use: “New Zealand’s Ministry of Health wrote letters to the manufacturers of mesh – including midurethral slings – requesting that they stop marketing their products in the country, unless they could produce evidence proving their safety and efficacy. This effectively results in a ban in all transvaginal mesh, including SUI treatments.” (

If you, a family member, a loved one, a friend, or anyone you know has had pelvic surgery that involves mesh and had complications wherein the mesh fell apart, it may be time for you or that other person to contact a lawyer. There are statutes of limitations (deadlines), so waiting too long can mean no case. Paul J. Molinaro, M.D., J.D. offers free consultations on mesh cases for patients who had surgery in California.

Removing Vaginal mesh Is “Possible”

“Transvaginal mesh removal is a technically complex surgical procedure in which surgeons attempt to remove as much of the mesh as possible. Complete transvaginal mesh removal is possible for some women, while only part of the mesh can be removed in other women due to complicated issues from the type of mesh that was originally used.” ( Well, anything is possible… highly likely… very probable… those would be better terms for the victims to hear… if true.


Some Quick Points about Transvaginal Mesh

"Unfortunately, an increasing number of women report serious complications from transvaginal mesh
used for prolapse that severely impact their quality of life."

"Research has shown that surgical mesh for transvaginal repair of POP can cause complications such
as mesh erosion, pain, infection, bleeding, pain during sex, organ perforation and urinary problems.
Many of these complications require additional treatment, including surgery."

"Report: FDA panel wants more extensive data, quality of life outcomes for vaginal mesh products."

"Australia and Britain have stopped vaginal mesh implants — California should, too."