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Essure 14 articles

FDA promises continued oversight of Essure despite its withdrawal from market

Bayer’s controversial permanent nonsurgical contraceptive device Essure will no longer be sold or distributed in the United States after the first of the year in response to thousands of complaints, but the Food and Drug Administration (FDA) will continue its oversight of the device still implanted in thousands of women. Its manufacturer also is required to continue to study Essure side effects for the next five years and provide reports to the FDA. “When new safety concerns arise for particular devices, we’re committed to taking action to develop post-market information that can help patients and providers make more informed decisions ... Read More

Netflix documentary reveals dangers of medical devices

The Netflix documentary The Bleeding Edge, directed by Kirby Dick, casts a dim light on the $400 billion-dollar medical device industry and the regulatory agency charged with protecting consumers against dangerous drugs and medical devices. The documentary focuses on several people who received or were treated with a medical device – from vital devices like hip implants and blood clot catchers to elective ones like breasts implants and contraceptive devices. These patients trusted their devices were safe, but later found the products were never tested for safety and efficacy, learning they were essentially guinea pigs. One patient is an orthopedic ... Read More

Bayer halts sales, distribution of Essure birth control

Bayer’s permanent birth control device Essure will no longer be sold or distributed after Dec. 31, 2018, the company announced. The decision comes after a safety action by the Food in Drug Administration (FDA) in April during which the agency restricted the sale and distribution of the device. It was a unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance that Essure was safe and effective. This action resulted in a 70 percent decline of Essure sales in the U.S., Bayer reported. As a result, the company decided to stop ... Read More

FDA restricts sales of permanent birth control device Essure

Sales of the permanent birth control device Essure have been restricted by the Food and Drug Administration (FDA) for only doctors and health care facilities that agree to go over a checklist with women before the device is implanted explaining possible risks. The action comes more than a year after the FDA ordered manufacturer Bayer to update the safety label of Essure to include a black box warning about potential injuries associated with use. Essure was approved by the FDA in 2002. It consists of two nickel alloy coils that are inserted into the each of the fallopian tubes. Over ... Read More

FDA chief updates public about Essure side effects review

Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., last month met with a group of women who claim to have been injured by the permanent birth control device Essure, and issued a statement updating the public on steps the agency has taken and plans to take in the future to better ensure patient safety. Essure is a device that consists of two small, metal coils that are implanted in the fallopian tubes. The device is designed to prevent sperm from reaching the egg. It is a permanent form of birth control that has been used on more than 750,000 ... Read More

Women want Essure cases in state court

Nearly five dozen women suing Bayer over claims that its permanent birth control device Essure perforated their uteruses and is linked to other injuries asked a California federal judge to send their case back to state court, arguing that only state law applies, according to Law360. The case was originally filed in Contra Costa County Superior Court in February, but was removed to federal court a month later. The complaint alleges Bayer violated California negligence, strict products liability, warranty and fraud statues. Bayer argued the case belonged in federal court because it implicates the Federal Food, Drug and Cosmetic Act ... Read More

FDA approves Bayer’s Kyleena IUD

Pharmaceutical company Bayer may be embroiled in lawsuits over its permanent birth control device Essure, but that isn’t keeping the company from pushing yet another contraceptive device. The company announced that it has just won Food and Drug Administration (FDA) approval for Kyleena, an intrauterine device, or IUD, designed to prevent pregnancy in women for up to five years. The device is similar to Bayer’s currently marketed IUDs, including Mirena and Skyla. All three are T-shaped devices that release a small amount of the hormone levonorgestrel. Actavis Plc, now known as Allergan Plc., won approval for the hormonal IUD Liletta ... Read More

FDA approves Bayer’s study plan for tracking Essure side effects

The Food and Drug Administration (FDA) has given the go-ahead to Bayer’s updated post-market surveillance study plan for its non-surgical permanent birth control device Essure. The controversial contraceptive has been linked to tens of thousands of adverse events including allergic reactions, autoimmune reactions, unintended pregnancies, miscarriages and fetal deaths, and four cases of adult death. The device can also migrate from its intended position in the fallopian tubes and damage neighboring tissue and organs. Essure, made by Bayer and approved for marketing in the U.S. in 2002, consists of two nickel alloy coils that are inserted into the fallopian tubes ... Read More

Ariel Grace’s law aims to give people harmed by medical devices their day in court

On June 8, exactly one year after the death of Ariel Grace, a bipartisan bill was introduced in the U.S. House of Representatives that would allow citizens claiming they were harmed by certain medical devices the opportunity to sue the manufacturer. Ariel Grace’s law (H.R. 5403) stems from a U.S. Supreme Court ruling (Riegel vs. Medtronic) that protected manufacturers of certain medical devices from litigation. It is named to honor the in utero loss of Ariel Grace, who died at 27-28 weeks gestation due to the failure of a permanent device, Essure. Essure, made by Bayer, was approved in 2002 ... Read More

Rep. Fitzpatrick to announce medical device reform bills

This week, Rep. Mike Fitzpatrick (R-PA) along with Rep. Louise Slaughter (D-NY) will announce a package of bills aimed at strengthening the Food and Drug Administration’s (FDA) medical device review process and increasing the accountability for dangerous products. They will be joined by women and families affected by medical devices including the permanent birth control method Essure and the laparoscopic hysterectomy device power morcellator. Speakers will share the emotional effects they say they experienced as a result of these allegedly failed medical devices, and their fight for justice. Fitzpatrick has been the leading voice in Congress calling for medical device approval ... Read More