cbsnews.com
Essure Birth Control Device Faces 27,000 Complaints, FDA Scrutiny
The Essure permanent birth control device, despite FDA approval, has prompted nearly 27,000 complaints since 2002 due to reported severe side effects like pain and organ perforation, leading to sales restrictions, a black box warning, and a mandated FDA post-market trial concluding in 2023.
- What are the immediate health consequences and systemic impacts stemming from the reported side effects of Essure, and how has the FDA responded?
- Tens of thousands of women have reported severe side effects from Essure, a permanent birth control device, including pain, allergic reactions, and organ perforation. The FDA has received nearly 27,000 complaints since 2002, leading to sales restrictions and a black box warning. Women report significant impacts on their lives, some undergoing hysterectomies.
- What are the underlying causes of the reported adverse events associated with the Essure device, considering both Bayer's and physicians' perspectives?
- The Essure device, despite Bayer's claims of low adverse event rates, has prompted widespread complaints and impacted sales. Doctors like Brett Cassidy, initially an Essure implanter, have since performed over 100 hysterectomies to remove the device due to severe patient reactions. The FDA's mandated post-market trial, concluding in 2023, aims to compare Essure's side effects to tubal ligation.
- What are the long-term implications for medical device regulation and patient safety, given the scale of Essure-related complaints and the ongoing FDA investigation?
- The Essure case highlights the challenges of post-market surveillance and the potential disconnect between manufacturer claims and patient experience. While Bayer asserts acceptable risk rates, the high volume of complaints and reported severe consequences necessitate a critical review of long-term safety and efficacy. The 2023 FDA report will be crucial in assessing the true scope of Essure's health impacts.
Cognitive Concepts
Framing Bias
The narrative is structured to highlight the negative consequences of Essure. The headline (not provided, but inferable from the text) likely emphasizes the suffering of women and the high number of complaints. The opening paragraph immediately establishes a negative tone with the mention of "painful and serious side-effects." The inclusion of quotes from women detailing their negative experiences, placed prominently throughout the piece, further reinforces this framing. The counterarguments from Bayer and its consultant are included, but they are placed later in the article and presented in a less emphatic way. This arrangement of information influences the reader to perceive Essure primarily as harmful.
Language Bias
The article uses emotionally charged language to describe the negative experiences of women who had complications with Essure, such as "painful and serious side-effects," "severe allergic reactions," and "perforated organs." These phrases contribute to a negative perception of the device. While the article attempts to present some counterarguments, the emotional descriptions of negative experiences overshadow them. Neutral alternatives could include more clinical language or a greater emphasis on statistical data to balance the emotional impact.
Bias by Omission
The article focuses heavily on the negative experiences of women who suffered side effects from Essure, giving a strong platform to their accounts. However, it omits the perspectives of women who had positive experiences with the device. While mentioning that over a million women worldwide have used Essure, the article doesn't include data on the percentage of those women who experienced no significant side effects. This omission creates a skewed perception of the overall safety and efficacy of the device.
False Dichotomy
The article presents a false dichotomy by focusing primarily on the negative experiences with Essure, thereby implicitly suggesting that the only possible outcomes are severe side effects or no problems at all. The complexity of individual responses and the range of experiences (from mild discomfort to severe complications) are not fully explored.
Gender Bias
While the article focuses on women's experiences, it does so to highlight their suffering related to a medical device. The gendered nature of the issue (Essure being a female birth control device) is not presented in a biased way. There is no evidence of gender stereotypes or the use of language that disproportionately focuses on physical appearance or other irrelevant details.
Sustainable Development Goals
The article highlights numerous cases of women experiencing severe adverse health consequences, including chronic pain, allergic reactions, and organ perforation, due to the Essure birth control device. This directly contradicts SDG 3, which aims to ensure healthy lives and promote well-being for all at all ages. The device's negative impact on women's health, coupled with the significant number of complaints and subsequent FDA actions, clearly demonstrates a substantial setback to achieving this goal.