Thousands of Essure Adverse Events Reported to the FDA
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In July 2018, Bayer announced that it would no longer sell Essure, the permanent birth control device. This decision to…
Cancer-Linked Breast Implants Are Being Permitted to Stay On US Market
American health authorities opted to permit a kind of breast implant to stay on the market recently. The objection from many in the medical field is that this particular implant has been linked to an unusual type of cancer. The decision makers argued that the risks posed by this implant are not great enough to...
Strict Regulations From the FDA on E-Cigarette Sales
E-cigarettes are increasingly becoming the “safer alternative” to regular cigarettes, but the truth is that e-cigarettes are not 100% safe and have unique risks, despite being different than a tobacco cigarette. This new e-cigarette trend is being used by both former smokers and minors who have easy access to the product. Due to the large...
Fisher-Price Issues Recall of Rock ‘n Play Sleepers After Being Linked to Infant Death
When you purchase new items for your baby, you never dream that the item will ultimately end up causing the death of your infant. Unfortunately, that is exactly what has happened to 32 children whose parents purchased the Fisher-Price Rock ‘n Play Sleeper. As a result, all models of the Fisher-Price Rock ‘N Play sleepers...
Transvaginal Mesh Sale and Distribution Stopped by FDA
The United States Food and Drug Administration (FDA) published a press release on April 16th, 2019 that stated the sale and distribution of transvaginal surgical mesh within the United States was now banned, and that all major manufacturers had been officially and directly ordered to stop. The press release from the FDA specifically named Boston...
Breast Implant Manufacturers Issued Warning From FDA
Breast manufacturers Sientra Inc. and Mentor Worldwide were issued warning letters from the U.S. Food and Drug Administration (FDA). The manufacturers did not follow the FDA’s requirements for post-approval reports on their products. The reports are supposed to show long-term health risks linked to their silicone breast implants. All manufacturers of silicone breast implants are...
Medical Device Review Process Gets Updated by the FDA
On Monday, November 26, the U.S. Food and Drug Administration (FDA) stated it will be updating the review process for most medical devices before they are cleared for marketing. The FDA is implementing the update to encourage manufacturers to rely less on their older devices in showing that their new products are safe and effective....
California Appeals Panel Revives Suits Over Diabetes Drugs
On Tuesday, November 4, a California appeals court revived claims that diabetes drug makers, including Merck & Co., failed to warn consumers about their drugs’ pancreatic cancer risks. The revival of claims comes after the state appeals panel found that a lower court misinterpreted the U.S. Supreme Court’s ruling in Buckman Co. v. Plaintiffs’ Legal...
Polio Like Illness Diagnosed in Georgia
3 cases of Acute Flaccid Myelitis, AFM, have been reported in Georgia. So far, there have been 62 confirmed cases across the United States. AFM, which has polio-like symptoms, is on the rise. AFM affects the nervous system, specifically the spinal cord, and can cause paralysis. It can cause weakness in one or more limbs...
Silicone Breast Implants Increase Risk of Cancer
Although silicone implants were introduced as a more lifelike alternative to saline bags, studies warn that they also increase a woman’s risk of developing breast cancer, as well as the likelihood of a stillbirth. Based on research by medical professionals at MD Anderson, there are some unfavorable consequences of getting breast augmentation or reconstruction with...