The Food and Drug Administration allows some medical devices to be approved under what many consider to be a regulatory loophole called the 510 (k) Premarket Notification Process. This procedure allows medical devices to be approved by showing evidence that they are "substantially equivalent" to devices that are already on the market.

Devices approved under this process are not subject to the same intense scrutiny as other new devices that have to go through the full review process. The Stryker Rejuvenate and ABG II Modular Neck Hip Stem implants were both approved under this process, as were many other medical devices that have been linked with dangerous side effects.

E-mails obtained by the Associated Press show that health officials in North Carolina knew about the possibility of a fungal meningitis outbreak for five days before they notified the public. The most recent figures from the Centers for Disease Control show that 44 people have died since the outbreak began and 678 have been infected.

The e-mails show that CDC officials e-mailed state health officials to say that there was a possible case of fungal meningitis in North Carolina and that there was a possible link to the outbreak that began in Tennessee. The fungal meningitis outbreak has been linked to tainted steroid injections produced by the New England Compounding Center, which has since been closed and is under investigation.

Despite that notification, North Carolina state health officials did not issue a public alert until five days later, according to documents obtained by the Associated Press. There have been 17 cases of fungal meningitis in North Carolina since the outbreak began, and one person has died.

North Carolina state health officials say they waited to alert the public because they wanted to have all the facts before releasing information. A spokeswoman also said that North Carolina does not have a protocol in place for informing the public about health threats and so decisions are made on a case-by-case basis.

The Associated Press found that Indiana also waited nearly a week to inform the public of the outbreak.

No information has been released about how the state plans to change its protocol for notifying the public about future health risks (or if it does).

North Carolina Dangerous Drugs Lawyers

If you received one of the contaminated steroid injections from the New England Compounding Center and believe you suffered serious side effects as a result, you may be entitled to compensation for your injuries. Call the North Carolina dangerous drugs lawyers at the Law Offices of James Scott Farrin right now at 1-866-844-4262 for a free evaluation of your case.

Numerous studies have shown a link between taking certain antidepressants while pregnant and a higher incidence of birth defects. These antidepressants are known as SSRIs and they include popular brands such as Zoloft, Prozac, Wellbutrin, Lexapro, Paxil, Effexor, and Celexa.

The birth defects linked to these antidepressants are vast and range from malformations such as cleft lip or palette to life-threatening conditions such as neural tube defects or cardiovascular problems. Developmental disabilities are also possible.

Family planning shouldn't have to mean putting your life at risk. However, some women who received the Mirena contraceptive intrauterine device suffered serious health complications as a result.

The Mirena IUD is a flexible, T-shaped piece of plastic that is inserted in the uterus and releases the hormone levonorgestrel to help prevent pregnancy for a period of up to five years. The Mirena is also used to treat heavy menstrual bleeding.

Many potentially serious side effects have been linked to the Mirena IUD, including perforation of the uterus or cervix, embedding of the device in the uterine wall, expulsion of the device, infection, and pelvic inflammatory disease, or PID. The device has also been linked to reproductive issues including ectopic pregnancy, infertility, and miscarriage.

There have been some reports of an increased risk of certain kinds of cancers linked to the Mirena IUD, but research studies have been inconclusive.

The Food and Drug Administration warned the manufacturer of the Mirena, Bayer Healthcare Pharmaceuticals, about misleading marketing practices in 2009. In April, the agency sent a letter stating that its online marketing practices made "representations and/or suggestions about the efficacy" of the Mirena, "but fail to communicate any risk associated" with its use. Later that year, the FDA sent another letter warning that a script used for promotional events known as "Mirena parties" held in homes and other private locations also used misleading marketing practices by overstating the product's effectiveness while downplaying its risks.

The Mirena IUD was marketed deceptively for years, and thousands of women may have taken it and been put at risk for potentially serious health complications. If you received the Mirena IUD and believe you suffered serious side effects as a result, you may be entitled to compensation for your injuries. Call the Law Offices of James Scott Farrin at 1-866-844-4262 for a free evaluation of your case.