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K. Lindsay Rakers
K. Lindsay Rakers
Attorney • (314) 588-8500

Dangerous Medical Devices and Drugs Harming Women

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Recently, some medical devices and drugs that are used to treat women’s health issues have been in the news for simply making matters worse. From anti-depression medication like Zoloft to transvaginal mesh implants to surgically repair pelvic organ prolapse, these medical products have resulted in unnecessary harm to patients or their unborn children. Here’s just a few that have been making headlines recently:

Transvaginal mesh implants: Countless women suffer from pelvic organ prolapse (POP), a condition where the lower abdominal muscles weaken—often as a result of child birth—causing abdominal organs, such as the bladder, to drop or “prolapse”. It can be an extremely painful condition and may even require surgical repair. Last year, however, the FDA notified the public that an increasingly popular treatment method that uses a mesh implant to repair the damaged muscle tissue “may expose patients to greater risk” despite “no evidence of greater clinical benefit.

Zoloft and Paxil: Nearly 15 million individuals in the United States experience depression each year, the majority of them women. Effective treatment often might include medications known as selective serotonin reuptake inhibitors (SSRIs), some of which are marketed and sold as Zoloft and Paxil. But, some studies reveal that this class of drugs presents serious risks to the unborn children of women who take SSRIs during pregnancy. As the FDA noted as recently as December, there is potentially increased risk of a serious heart and lung condition known as persistent pulmonary hypertension in the newborn. While the research is not entirely conclusive, women who are seeking drug treatment for depression and who are considering a pregnancy have very difficult treatment options to take into consideration.

Depakote: Similar to the risks of antidepressant medications taken during pregnancy, Depakote and other drugs containing valporic acid, also present risks to unborn children if taken during pregnancy. This class of drugs is approved for the treatment of seizures, the symptoms of bipolar disorder, and migraine headaches. Ceasing treatment of any of those conditions may rarely be an option and doing so presents its own risks to unborn infant. But, so too does taking depakote during pregnancy. These drugs in particular have been linked to major birth defects, including neural tube defects, craniofacial defects, cardiovascular malformations and even spina bifida. The risk is so great that the FDA advises women and healthcare professionals to consider alternative therapies and reminds women to use effective contraception as the risk to the fetus is highest during the first trimester.

Of course there are problem drugs out there that aren’t just risky for women. Take Actos, for example. Actos is a drug that is typically used to treat Type II Diabetes or non-insulin dependent diabetes. But in June of last year, the FDA warned that long-term usage of Actos may be associated with an increased risk of bladder cancer, advising against its use for patients who have bladder cancer of have a history of bladder cancer.