A permanent birth control method, Essure (female sterilization), has been linked to serious side effects and complications. The Food and Drug Administration (FDA) approved Essure on November 4, 2002 for use under the Pre-market Approval (PMA) process. At the time of approval, Essure was manufactured and marketed by Conceptus, Incorporated (Bayer acquired Conceptus on June 5, 2013).
Since it’s approval, numerous PMA supplements have been reviewed and approved by the FDA, some resulting in labeling changes, notably:
- 2011: physician labeling updated to substitute a warning for a contraindication related to nickel. Current Essure labeling includes a nickel sensitivity warning.
- 2012: patient and physician labeling updated to include results of 5-year follow-up of subjects in Phase II and pivotal trials and information on pregnancies that have occurred in the commercial setting (i.e., outside of clinical trials).
- 2013: patient labeling updated to include risks of chronic pain and device migration.
While Essure offers benefits to patients requiring a permanent birth control method, there are also some side effects of which every user should be made specifically aware. Some side effects are mild and easily treated, but there are some other side effects that can signal a more serious and potentially deadly complication. If you suffer serious harm, we can help you pursue compensation from the medical device manufacturer or another liable party.
Essure is inserted through the vagina and cervix into the fallopian tubes. The procedure does not require a surgical incision. Some common side effects include mild to moderate pain, cramping, vaginal bleeding, dizziness, pelvic or back discomfort. If you experience any of these symptoms, you should notify your doctor right away.
Allergic foreign-body response reactions are possible with the use of this device. Emergency medical care should be sought in such cases.
Long-term risks to patients reported in clinical trials include unintended pregnancy, pelvic pain, perforation of the uterus or Fallopian tubes, migration of Essure inserts through the Fallopian tubes or uterus into the lower abdomen and pelvis.
Essure is also linked to other reactions following placement, not reported in clinical trials but included in medical device reports submitted to the FDA such as allergy or hypersensitivity reactions (nickel based device), joint or muscle pain, muscle weakness, excessive fatigue, hair loss, weight changes, mood changes, and/or or persistent fever. The FDA also required a black box warning (the most serious of all pharmaceutical warnings) that warned users of the risk of chronic pain and device migration. Patients who suffer from serious complications may speak with us about legal options.
The FDA conducted a search of the Manufacturer and User Facility Device Experience (MAUDE) database. From Nov. 4, 2002 (FDA approval date) through December 31, 2015, the FDA received 9,900 medical device reports related to Essure. The majority of reports received since 2013 have been voluntary reports, mostly from women who received device implants.
The most frequently reported patient problems during this period were pain/abdominal pain (6989), heavier menses/menstrual irregularities (3210), headache (2990), fatigue (2159), and weight fluctuations (2088). Most of the reports received listed multiple patient problems in each report. The most frequent device problems reported were patient-device incompatibility (2016) (for example, possible nickel allergy), migration of the device or device component (854), device operating differently than expected (490), device breakage (429), device difficult to remove (280), malposition of the device (199), and device difficult to insert (187). Multiple device problems can also be listed in each report.
Talk to Essure Attorneys if You Suffer Serious Side Effects
Patients or loved ones who have suffered serious side effects or died due to this device can file a claim for compensation from the drug manufacturer. Enlist the assistance of our lawyers to help build your case and advise you of your rights.
Gacovino, Lake & Associates specializes in cases like this, and our team is available to answer your questions and help you through the process of seeking reimbursement for losses and damages. Our attorneys will help you determine what course of action is most practical for the situation and will help ensure a positive outcome for your case. Call us today at 800-550-0000 for a free case review.