Tens of thousands of women have reported experiencing painful and severe side effects from Essure, a medical device intended for permanent birth control. Since its approval in 2002, the device has been the subject of nearly 27,000 complaints submitted to the FDA due to excessive pain, severe allergic reactions, and in some cases, organ perforation. In response to these concerns, the FDA has restricted sales to providers who offer a checklist of risks and implemented a black box warning for the product.
| Article Subheadings |
|---|
| 1) Overview of Essure and Its Approval |
| 2) Personal Stories of Pain and Suffering |
| 3) Medical Perspectives on the Device |
| 4) Bayer’s Response and Ongoing Litigation |
| 5) Future Directions and Regulatory Actions |
Overview of Essure and Its Approval
Essure is a medical device developed as a form of permanent birth control without the need for surgery. The device consists of two small, flexible coils that are inserted into a woman’s fallopian tubes, where they are intended to cause the formation of scar tissue that blocks the tubes hence preventing pregnancy. Approved by the FDA in 2002, Essure was initially marketed as a minimally invasive option that allows women to return to their normal activities almost immediately.
Despite its widespread use, Essure has faced scrutiny due to serious side effects reported by numerous patients. The FDA, recognizing the growing number of complaints, mandated a black box warning for the device in 2016, indicating that potential users need to discuss the risks comprehensively with their healthcare providers. This warning highlights severe adverse effects associated with the device, raising concerns about patient safety.
Personal Stories of Pain and Suffering
Women affected by Essure have shared their distressing experiences, describing life-altering pain and health complications. One such woman, Amanda Rusmisell, recounted how her life transformed after she received the Essure device. Initially seeking a solution for permanent birth control after having two children, she felt confident after her doctor described the device as non-invasive and straightforward.
“You can go back to work the next day, it’s not invasive, it will be no problem at all,”
she recalled. However, her situation quickly deteriorated as she experienced intense pain and debilitating menstrual issues. As her condition worsened, her physician dismissed her symptoms as age-related, ultimately leading to a recommendation for a hysterectomy at the age of 38. Rusmisell expressed her despair and feeling of helplessness during this period, struggling to find support among those who faced similar challenges.
Through social media, she discovered a community of women grappling with similar complications after undergoing Essure procedures. Shared experiences included drastic weight changes, rashes, and other severe side effects. Some even submitted images as evidence, reportedly showing damage caused by the device, such as perforated fallopian tubes.
Medical Perspectives on the Device
Many healthcare professionals have also begun to scrutinize the effects of Essure. Dr. Brett Cassidy, an Illinois doctor who initially endorsed the device, experienced a change of heart after treating patients with alarming symptoms linked to Essure. Among these were neurological issues, including migraines and brain fog, that seemed unlikely to be associated with a device designed for birth control.
After performing numerous hysterectomies, he found that removing the Essure devices led to immediate improvements in his patients’ health. “Within a week she was feeling 100 percent better,” he stated about one particular case. The implants made from nickel and polyester fibers can trigger inflammatory responses, leading to systemic reactions. This has raised questions about the long-term implications of having such devices implanted in a person’s body.
Bayer’s Response and Ongoing Litigation
Bayer, the manufacturer of Essure, has responded to the complaints by emphasizing that they take safety concerns seriously. They have maintained that their studies indicate a low and acceptable risk of adverse events associated with the device. In light of the complaints, Bayer has indicated that many of the symptoms reported by women might be hormonally related and not directly linked to Essure.
Amid rising discontent, women like Rusmisell have taken legal action against the company, reflecting their determination to hold Bayer accountable. They argue that the device should be removed from the market altogether, citing the profound impact on their lives. According to Bayer, the sales of Essure have tapered off, likely due to the ongoing scrutiny and negative publicity surrounding the product.
Future Directions and Regulatory Actions
The FDA is taking steps to assess the safety of Essure more rigorously by requiring Bayer to conduct a post-market trial. This trial aims to compare the side effects of Essure with those of traditional tubal ligation procedures, with a final report expected by 2023. This action underscores the ongoing evolution of regulatory oversight in light of rising health concerns and public pressure regarding the safety of medical devices.
Bayer’s head of communications emphasized that Essure has undergone extensive testing, claiming that its safety profile is comparable to that of tubal ligation. However, the compelling narratives shared by women impacted by the device continue to shape the public’s perception and the future of Essure as a birth control method.
| No. | Key Points |
|---|---|
| 1 | Essure has been associated with severe pain and health complications for many women. |
| 2 | The FDA has restricted sales and mandated a black box warning for the device due to safety concerns. |
| 3 | Healthcare professionals have reported correlations between Essure and various unexpected health issues. |
| 4 | Bayer maintains that the device’s benefits outweigh its risks, but women have pushed for its removal from the market. |
| 5 | Ongoing regulatory actions and lawsuits reflect the serious dilemma surrounding Essure’s safety. |
Summary
The ongoing controversy surrounding Essure highlights the complex balance between medical innovation and patient safety. As women continue to advocate for their rights and seek accountability for their suffering, the implications extend beyond individual cases, reflecting broader issues within the regulatory and healthcare landscapes. With the FDA’s upcoming trials and Bayer’s responses, the future of Essure remains uncertain but underscores the crucial need for informed medical decision-making.
Frequently Asked Questions
Question: What are the reported side effects of Essure?
Women have reported various side effects, including severe pain, heavy menstrual bleeding, allergic reactions, and even organ perforation.
Question: What actions has the FDA taken regarding Essure?
The FDA has restricted sales of Essure and implemented a black box warning, indicating serious potential risks associated with the device.
Question: How is Bayer responding to the complaints against Essure?
Bayer asserts that the device has been tested extensively and claims that its safety profile is acceptable compared to other forms of permanent birth control. They also emphasize that many reported symptoms may not be directly related to the device.
