MDL – Multidistrict Litigation

When many plaintiffs suffer similar injuries as a result of defective prescriptions or medical devices, the United States federal court system will have the cases transferred to one courtroom under one judge. This process is commonly known as uses multidistrict litigation (“MDL”). This process allows common issues to be decided one time and in the same way. Discovery and motions are done one time. Thus, the cases benefit from speed, efficiency and uniformity of rulings. MDL cases. Pending MDL cases as of April 15, 2019 are listed here: https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-April-15-2019.pdf.

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.” (https://www.medpagetoday.com/washington-watch/fdageneral/77134). “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.” (https://www.neuralit.com/mass-torts/devices/essure).

“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.” (https://www.massdevice.com/fda-updates-on-post-market-study-revisions-oversight-for-bayers-essure/). “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.” (https://www.neuralit.com/mass-torts/devices/essure).

“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?” (https://www.nwhn.org/bayer-has-recently-announced-they-will-remove-essure/).

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.

Removing Mesh Is Like Removing Rebar from Concrete

Medicine is supposed to be about risk/benefit. And the numbers here are important because the doctors told me that there have been estimated 4 million women worldwide have had mesh implanted. About 5 percent of them have complications. Well, that equals 200,000 people. And from reading about the complications, half of those people with complications require surgery. And the complications are very hard to get rid of. The one thing I was told: removing mesh from the human body is like getting bubblegum out of hair. Another analogy I heard was getting rebar out of concrete. So it’s a lifelong problem.” (https://news.wttw.com/2019/02/12/fda-assessing-risks-vaginal-mesh-amid-thousands-lawsuits).

18,000 Essure Lawsuits

As of February 2019, Bayer was facing about 18,000.00 Essure plaintiffs. (https://www.jurist.org/commentary/2019/02/female-filings-a-look-into-the-current-essure-lawsuits/). “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.” (https://www.jurist.org/commentary/2019/02/female-filings-a-look-into-the-current-essure-lawsuits/).

#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.” (https://www.cbsnews.com/news/essure-birth-control-fda-women-report-pain-side-effects/). “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.” (https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/essurepermanentbirthcontrol/ucm452250.htm). “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.” (https://www.mayoclinic.org/tests-procedures/essure/about/pac-20394017).

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."
(http://obgyn.ucla.edu/mesh-related-complications).

"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."
(https://www.mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/in-depth/transvaginal-mesh-complications/art-20110300).

"Report: FDA panel wants more extensive data, quality of life outcomes for vaginal mesh products."
(https://www.massdevice.com/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."
(https://www.sfchronicle.com/opinion/openforum/article/Australia-and-Britain-have-stopped-vaginal-mesh-13315968.php).

Surgically Implanted Mesh: Risks, Benefits, Complications

“Surgical mesh is a medical device that is used to provide extra support when repairing weakened or damaged tissue. Most surgical mesh devices are made from synthetic materials or animal tissue.” (https://www.mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/in-depth/transvaginal-mesh-complications/art-20110300). No doubt, you’ve seen the reports (some disguised as commercials) about the dangers of pelvic mesh. You probably wouldn’t have found this posting if you weren’t looking for more information. Let me start by saying the idea of surgical repair using a net is not new, not bad in and of itself, and has helped many women. Let me also say that this product has made an enormous amount of money for the manufacturers and distributors of mesh. And, it has made a lot of money for the surgeons who implant this mesh. When there is so much money to be made, people get greedy and downplay risks while overemphasizing benefits. Misrepresentations were made to the public and to the doctors.

Some doctors quickly realized the dangers of mesh surgery for Pelvic Organ Prolapse (“POP”) and Stress Urinary Incontinence (“SUI”) and reserved the procedure to those limited situations where the benefits outweighed the risks. “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. (https://www.mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/in-depth/transvaginal-mesh-complications/art-20110300). ” The FDA has “planned to convene an advisory committee meeting to share the available evidence and seek expert opinion on the evaluation of the risks and benefits of these devices. The Committee will be asked to provide scientific and clinical input on assessing the effectiveness, safety, and benefit/risk of mesh placed transvaginally in the anterior vaginal compartment, as well as identifying the appropriate patient population and physician training needed for these devices.” (https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm). “The complication rate within 5 years of the mesh procedure was 9.8 [9.6:10.0]% ” (https://www.nature.com/articles/s41598-017-11821-w).

Some doctors believe that, despite the high risks of complications, they can implant mesh safely. “Vaginal mesh can be a safe and effective treatment option when used for the right candidates by experienced surgeons who are skilled in the appropriate surgical techniques. “Complications can occur with any surgery,” explained Dr. Visco, but those complications can be minimized when surgeons select appropriate candidates for the procedure and when doctors are skilled in the proper surgical techniques and experienced with vaginal mesh procedures.   In addition, surgeons who utilize mesh should have had training on how to manage mesh complications.” (https://www.dukehealth.org/blog/vaginal-mesh-dangerous-learn-facts).

And then, it appears that some doctors turned a blind eye to the risks and implanted mesh in any patient they could talk into getting surgery, because “millions” of women had mesh implanted. “In the last two decades, millions of women have turned to vaginal mesh implants as a possible solution to two annoying problems: urinary incontinence and pelvic organ prolapse, where body parts shift out of place due to childbirth or the ageing process.” (https://www.thedailybeast.com/the-million-dollar-deal-behind-the-vaginal-mesh-implant-mess).

According to the Cleveland Clinic, some complications associated with mesh implants are:
– Vaginal mesh erosion: This 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
– Vaginal mesh contraction: Shortening or tightening of the mesh over time can cause vaginal shortening, tightening, or pain
– Pain during sexual intercourse
– Urinary problems
– Infections
– Bleeding
– Tearing of organs
– Pelvic organ prolapse that returns
– Emotional problems

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.