Defective medical devices have impacted tens of thousands of Americans in recent years, particularly faulty hip implants, breast implants and transvaginal mesh—the last 2 of which exclusively affect women.
In addition to defective medical devices for only female patients, women also experienced the most negative post-surgery effects of supposedly gender-neutral devices, such as heart and hip implants.
For these reasons, American women are more likely to be harmed by medical devices than men.
Why is this happening?
According to one researcher, there exists gender biases at all stages of design and use of medical implants.
Medical device regulation and clinical trials
Some efforts have already been made to identify loopholes within the regulation system to try and reduce the negative effects experienced by patients. For instance, in May 2019 the FDA ended its alternative summary reporting program.
However, many women still experience pain and suffering after surgery because companies who design, produce and sell their medical products are cutting corners when it comes to testing that allows them to market their products before they’ve met the requirements set forth by the U.S. Food and Drug Administration (FDA).
For example, women aren’t always included in medical trials for gender-neutral devices. Other challenges when it comes to how medical devices impact women include, the consideration of patient activity aren’t and doctor-patient relationships.
Clinical trials lack proper testing
Data collected during clinical trials is often skewed due to the lack of women participants, and yet the FDA still approves the devices with little to no evidence of how those devices might affect females differently than males.
The patient’s level of activity is also commonly ignored when it comes to medical device testing. Across the board, patients have different tasks and daily performance levels which can vary the stress placed on a medical device.
For example, if one patient enjoys running 5 miles every day, they may require a different joint implant than a patient who doesn’t jog at all. Or, if a woman has an infant or more than one child, she might be using her joints and muscles more than a woman in her 80s with no children or grandchildren.
Medical trials rarely account for these vital lifestyle factors.
Having a doctor who listens and takes the patient’s concerns into account has always been important. In recent years, though, there’s been an increasing demand for such doctors — especially for female surgeons since they’re often more knowledgeable when it comes to how gender-neutral medical devices will affect the female body and can inform their patients of these differences.
Across the globe
It’s not just women in the United States who are experiencing difficulties with gender-neutral medical devices. Australia and the U.K. are also facing a higher number of medical device recalls without explanations as to why, as well as devices being approved by officials based on inaccurate data.
If you or a loved one are suffering from a medical device such as a joint or heart implant, our Tennessee medical device lawyers can help you file a claim and receive the benefits you deserve to cover any medical costs caused by a faulty device.