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.

Does Essure Fail Every Test?

“It is estimated, however, that nearly 10,000 of U.S. Essure patients required additional operations after their original procedure. This is due to anything from severe side-effects, the device traveling to different areas of the body, or perforations and tears requiring medical procedures. Dr. Katy Moncivais, PhD, Medical Writer tells me: “Essure fails every test – it’s less safe, less effective, and more side effect prone than most other methods of birth control.” ” (https://www.girlsglobe.org/2019/04/03/womens-reproductive-health-under-attack/).

How Did Essure Get Approved? Here’s One Opinion

https://www.hormonesmatter.com/essure-debacle/

“The FDA requires a Premarket Approval (PMA) to review and evaluate the safety and effectiveness of Class III medical devices like Essure. FDA regulations require that this takes 180 days, and normally longer, but there are records that show that this process was expedited and several trial candidate’s records were altered to obscure unfavorable data. Some patients were completely thrown out of the clinical trials when their data reflected poorly on the device. According to the citizen’s petition linked above, there were many adverse events that Essure manufacturers and PMA holders failed to report and/or covered up. Additionally, over 16,000 patient complaints were withheld from the FDA. When the manufacturing facilities were inspected, many unsettling thing came to light, starting with the facility’s lack of license. The manufacturer of Essure were operating without a license for three years.” (https://www.hormonesmatter.com/essure-debacle/).

MESH & OXYCONTIN!

“Her last surgery—ostensibly to remove the mesh—was five years ago. “My surgeon told me the mesh was impossible to remove because it was stuck to my bowel and had even migrated to my intestines. Next up I went to a pain management clinic: I have this constant aching pulling feeling and sharp pains like someone is kicking at me. It started just above my belly button but now the pain has spread… and I’ve been on oxycontin [the brand name for Oxycodone] since 2015.”” (https://www.lawyersandsettlements.com/legal-news/mesh-complications/abdominal-mesh-victim-prescribed-oxycontin-could-pain-have-been–23068.html).

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).