FDA Finalizes Guidance on Essure Birth Control Boxed Warning After Essure Side-Effects Investigation

   

Essure Birth Control Lawsuits Claim Women Have Suffered Serious Injuries Such As Punctured Organs, Miscarriages, And Hysterectomies.

Essure-Birth-Control-Lawsuits-Southern-Med-LawAs Essure birth control lawsuits are filed by women, the U.S. Food and Drug Administration (FDA) has finalized its guidance for the boxed warning and patient decision checklist for the Essure birth control system. The FDA has been investigating Essure side effects for over a year after receiving numerous complaints the birth control device can cause unintended pregnancies, miscarriages, chronic pain, organ perforation, hysterectomies and fetal death. The FDA believes this will help women understand the benefits and risks associated with the contraceptive. While the FDA intends to require these components on Essure’s labeling, critics of Essure have called for the federal agency to ban the device from the market. Women around the country have been filing Essure birth lawsuits stating Bayer failed to adequately warn of Essure’s serious side effects.

“It is important for doctors to make sure that their patients understand every item on the checklist and the possible complications that may occur after having an Essure implant,” says Dr. François Blaudeau, founder of Southern Med Law, who is also a practicing obstetrician/ gynecologist and a strong advocate for woman’s medical issues. Dr. Blaudeau has won and settled serveral cases where women’s health is involved.

The firm is currently representing numerous women in Essure birth control lawsuits. You can arrange for a no obligation legal review to learn more about your options. To speak with one of the firm’s attorneys you can call 205-547-5525 or visit www.southernmedlaw.com to fill out a contact for and receive more information.

The FDA’s finalized document included some updates from its draft of Essure’s boxed warning and patient decision checklist. For instance, the boxed warning in the draft mentioned that adverse events had been reported with Essure. The final guidance listed the adverse events that include:

• Perforation of the uterus and/or fallopian tubes
• Identification of inserts in the abdominal or pelvic cavity
• Persistent pain
• Suspected allergic or hypersensitivity reactions

The finalized boxed warning also adds that a “surgical procedure will be required” if Essure needs to be removed to address adverse events. The patient checklist highlights the risk and benefit information of Essure which the FDA says should be reviewed and signed by the patient and physician. The checklist is also grouped in topics that include birth control options, long-term risks of Essure, and information on effectiveness and chances for unintended pregnancy and ectopic pregnancy, including a statement that no contraceptive device is 100 percent effective. Prior to finalizing its guidance document, the FDA sought input from the public and received more than 1,300 comments.
[fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM488020.pdf]

Essure is a permanent birth control system approved by the FDA in 2002. The small device has flexible coils that are placed into each fallopian tube. Insemination is prevented because the fallopian tubes are blocked by scar tissue that forms around the coils over a three-month period. Since Essure’s approval on November 4, 2002 to December 31, 2015, the FDA received more than 9,900 reports about Essure. According to the agency, the most frequently reported complaints patients were pain/abdominal pain, menstrual irregularities, headache, fatigue, and weight fluctuations. Additionally, four adult deaths were reported, along with 15 incidences of pregnancy loss, and two incidents of a death of an infant after live birth.
[fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm]

Court documents in Essure birth control lawsuits indicate that the Essure complaints allege that Bayer, which manufactures Essure, failed to adequately warn that its permanent birth control system causes allergic reactions to nickel, pelvic pain, fatigue, headaches, ectopic pregnancies and other side effects. In September, about 55 Essure side effects complaints representing 900 women were consolidated for pretrial proceedings in the Alamada County Superior Court in Oakland, California. In addition, more than 30 Essure lawsuits representing over 1,000 women are pending in federal courts nationwide.

About Southern Med Law And Filing An Essure Birth Control Lawsuit

Throughout his career, Dr. Blaudeau has worked hard to develop a strong reputation in healthcare litigation. His first-hand knowledge of medicine has made Southern Med Law an aggressive and effective advocate for those who were harmed due to negligent medical device manufacturers. If you or a loved one were injured by Essure side effects, please contact Southern Med Law today to learn more about your legal rights. You can arrange for a free, no obligation Essure side effects lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.

Contact:
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525

Fax: 205-547-5526
francois@southernmedlaw.com

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