Baltimore Medical Product Liability Lawyers: FDA Investigating Birth Control ImplantOctober 1, 2015
Recently, the Food and Drug Administration held a day-long hearing to address concerns over the popular birth control implant Essure. A panel of experts and members of the pubic discussed the safety and effectiveness of the medical device, marketed as the first and only nonsurgical permanent contraceptive implant currently available. The hearing comes amid a wave of lawsuits filed against Essure’s maker, Bayer HealthCare Pharmaceuticals.
Essure consists of two tiny metallic coils inserted into the fallopian tubes that are designed to induce tissue growth and render the woman sterile. The procedure, which has been marketed as a safe alternative to tubal ligation surgery and other forms of birth control, can be completed in a doctor’s office in just minutes. Approximately 750,000 Essure devices have been sold worldwide since the device became available in 2002.
Reports of problems began soon after Essure hit the market, but have surged in recent years as more women have opted for the implant. Between November of 2002 and May of 2015, the FDA received more than 5,000 complaints by women reporting problems ranging from allergic reactions and unintended pregnancy, to perforations of the uterus and more. Nearly half of those complaints were filed just last year. Commonly reported issues include:
- Device failure – Between 2002 and 2010, there were at least 660 reports of unintended pregnancies by women who thought they were protected by the Essure implant.
- Skin problems, hair loss and allergic reactions – Many women experienced reactions to nickel leaked in small amounts from the device.
- Fatigue, persistent pain, weight gain and depression
- Perforation of the uterus or fallopian tubes
- Intra-abdominal or pelvic device migration
- Abnormal or irregular bleeding
- Stillbirths – In at least one case, a woman gave birth to a stillborn baby after her Essure coil ruptured her amniotic sac.
Other problems were attributed to a lack of proper training for the implantation and removal of the device, as well as a lack of an established protocol for identifying complications. Many women who experienced problems have had to undergo surgery to remove the device. Some were forced to seek a hysterectomy operation because they were unable to find a doctor trained in removing the Essure implant.
Experts are calling for more thorough research into the potential safety risks of Essure, citing a lack of comprehensive studies performed by independent agencies. They also say that more needs to be done to provide women with access to health care systems related to all steps of the Essure system, including access to confirmation tests and access to physicians trained in device removal. For now, the FDA suggests limited use of the Essure implant in women who have a known sensitivity to metal or a history of autoimmune disease, pelvic inflammatory disease or abnormal uterine bleeding.
Maryland Medical Malpractice Lawyers at LeViness, Tolzman & Hamilton Fight For Those Harmed by Dangerous Medical Devices
To learn more about dangerous medical devices and find out what legal options are available to you, call Maryland medical product liability lawyers at LeViness, Tolzman & Hamilton today to schedule a free and confidential consultation. A compassionate and knowledgeable member of our legal team is available to take your call 24 hours a day at 800-547-4LAW (4529) or you can contact us online.
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