Food and Drug Administration

Posts Tagged With ‘Food and Drug Administration’

The United States Food and Drug Administration announced a mandatory clinical study of the birth control implant Essure. The study will examine risks for particular groups of women.

The FDA also announced new plans to change the labels on Essure. A new boxed warning and a Patient Decision Checklist will help highlight potential risks and make sure women understand what they are getting into with the device.

Essure is a permanent form of birth control that has garnered much attention – good and bad – over the years. Essure coils are inserted into the fallopian tubes through the cervix and vagina. Over a three month period of time, scar tissue forms around the coils. This scar tissue creates a barrier, preventing sperm from getting through and therefore preventing pregnancy. Though the FDA insists that Essure is safe and a good option for some women, there have been some scary side effects in some users.

Persistent pain is just one nasty side effect. Some women experience perforation of the fallopian tubes and uterus when the Essure device migrates in the body. Others have experienced abnormal bleeding, allergic and hypersensitivity reactions.

The FDA is also requiring Bayer, the maker of Essure, to conduct a study on the risks of the device in the real world. The results will be compared against more traditional forms of permanent birth control like tubal ligation.

We applaud the FDA for mandating this new clinical study. The results of the study will help medical professionals and Essure users alike better understand the way the device helps – or harms – patients.

Essure Injury Lawsuits

The Law Offices of Richard J. Serpe, PC are currently investigating potential injury claims for anyone who has suffered from complications or has been seriously injured by an Essure permanent birth control device. If you’d like to discuss your situation, contact us to set up a free consultation 877-544-5323.

When a woman determines that she’s done having kids, most turn to doctors for tubal ligations. In recent years, however, medical advances have made it possible to forgo this surgery in favor of an implanted medical device. Sounds great, right?

Instead, women experienced painful symptoms. Severe abdominal pain. Rashes. Itching. Fatigue, headache and weight fluctuations. No woman would ask for these symptoms, yet women around the country are experiencing them thanks to a defective medical device known as Essure. The device, designed to permanently prevent pregnancy, has been in the spotlight recently because of its failures. Not only are women getting pregnant in spite of having Essure implanted, many are seeing dangerous – and even deadly – symptoms related to the device.

Essure was created as an alternative to traditional sterilization processes like tubal ligation. The small, flexible coils are inserted into the fallopian tubes by a doctor with no surgery required. Over the span of a few months, tissue grows around the device, creating a blockage that prevents sperm from reaching a woman’s eggs. The initial procedure only takes about ten minutes, with a follow up appointment held a few months later to determine the progress of the tissue growth. It sounds like an ideal alternative to getting your tubes tied, but Essure can have dangerous side effects.

The Food and Drug Administration reports that short-term risks related to the device include cramping, mild bleeding and pelvic or back discomfort. Unfortunately, those symptoms are just the beginning for some women using Essure. Because it is made out of nickel, some people report itching and rashes related to nickel allergies. Shockingly, the flexible coils that make up the device have been known to break apart and travel throughout the body. Attempts to remove the broken implant can require multiple surgeries, and some women have needed their entire uterus removed.

The FDA has received thousands of complaints about Essure over the years, yet no recall has been announced for this device.

Essure Birth Control Injury Lawsuits

The Law Offices of Richard J. Serpe, PC are currently investigating potential injury claims for anyone who has suffered from complications or has been seriously injured by an Essure permanent birth control device.

If you or a loved one has suffered from an injury related to an Essure permanent birth control device, you may want to contact an attorney. Our dangerous and defective products attorneys offer a free, no obligation, consultation. Additionally, our no fee promise means you don’t owe us any legal fees unless we settle or win your case. Contact us to discuss your situation today 877-544-5323.

How often do you read warning labels on the products you use regularly? And how much weight do you give those warnings?

FDA Requiring Bayer to Complete A Post-Market Study

The Food and Drug Administration has announced a new requirement for Essure packaging: warning labels and a patient decision checklist. The FDA will also require Bayer, the medical device’s manufacturer, to conduct post-market studies of the sterilization coils. This decision comes after more than 5,000 adverse event reports from women who have had Essure implanted in their Fallopian tubes. The device, designed to permanently prevent pregnancy, has been known to break apart and move around within the body. For some women, these complications have meant chronic headaches, bleeding, unintended pregnancies and even hysterectomies. The FDA is now requiring Bayer to complete a post-market study of the device.

Some Say the Essure Device Should be Recalled

For some anti-Essure advocates, the FDA’s requirements don’t go far enough to protect women who might consider using Essure. Though the studies required of Bayer might seem like a good idea to better understand the potential problems with the device, Essure remains in the marketplace, potentially harming countless other women as the research is conducted. As long as Essure remains on the market, the critics say,  there is risk for women.

When the Risks Outweigh the Benefits

The decision to choose the birth control that is right for you is a critical one. We need to ensure women have all the facts about a given product, and when that product’s risks outweigh its benefits, it needs to be taken off the shelf. No woman would expect to experience the symptoms related to this device, nor would they anticipate needing multiple surgeries to remove Essure. Yet this exact scenario has occurred time and time again. The study and its results should have been factored into the initial approval of the product, not an afterthought more than a decade after its release.

While we applaud the FDA for implementing the new warning label requirement of Bayer, more needs to be done to protect the women who are considering using Essure.

Free Consultation, No Fee Promise.

The Law Offices of Richard J. Serpe, PC are currently investigating potential injury claims for anyone who has suffered from complications or has been seriously injured by an Essure permanent birth control device.

If you or a loved one has suffered from an injury related to an Essure permanent birth control device, you may want to contact an attorney. Our dangerous and defective products attorneys offer a free, no obligation, consultation. Additionally, our no fee promise means you don’t owe us any legal fees unless we settle or win your case. Contact us to discuss your situation today 877-544-5323.

Talcum Powder LawsuitsWe trust the companies we buy from to have our best interests in mind. After all, our best interests are their best interests, right? Unfortunately, this isn’t always true – and that’s where federal oversight of the products we buy and use daily is so important. But what if federal agencies like the Food and Drug Administration didn’t have all the facts presented to them accurately?

In 2014, a plaintiff claimed that Bayer, the creator of Essure, actively concealed negative reports from the Food and Drug Administration. This concealment allowed for the pharmaceutical giant to gain premarket approval for the device, which guards a company against product liability lawsuits. The lawsuit also claims that doctors were inadequately trained in the implanting process. Three coils – instead of the intended two – were implanted into the plaintiff’s Fallopian tubes, eventually leading to five hospitalizations and a hysterectomy.

Two years later, the FDA has mandated new warnings for Essure. It recently announced it will require black box warning labels for the device, calling attention to “serious or life-threatening risks.” The FDA will also require Bayer to study women undergoing the sterilization process, be it through Essure or another method.

Still, some advocates say this is not enough. The device still remains on the market and there is no enforcement for the FDA’s recommendations for Bayer. “I feel as if the FDA truly failed these women,” one advocate told CNN.

More than 5,000 adverse events have been reported to the FDA in the years following the approval of Bayer’s Essure permanent birth control device. Complaints range from abdominal pain to unintended pregnancy to organ perforation.

Free Consultation, No Fee Promise.

The Law Offices of Richard J. Serpe, PC are currently investigating potential injury claims for anyone who has suffered from complications or has been seriously injured by an Essure permanent birth control device.

If you or a loved one has suffered from an injury related to an Essure permanent birth control device, you may want to contact an attorney. Our dangerous and defective products attorneys offer a free, no obligation, consultation. Additionally, our no fee promise means you don’t owe us any legal fees unless we settle or win your case. Contact us to discuss your situation today 877-544-5323.