Archive for the ‘FDA’ Category

FDA to Investigate Safety of Essure Birth Control

August 6th, 2015 at 12:11 pm

birth control safety, safety of essure birth control, Westport Personal Injury LawyerReports of serious concerns over a popular contraceptive, used by countless women, is coming under federal review due to multiple reports of dangerous medical complications suffered by women who have used the device.

The Food and Drug Administration (FDA) has announced that they are reviewing the safety of the implant Essure. The contraceptive device is manufactured by Bayer and has been on the market since 2002. The device is made of two metal coils which are inserted into the fallopian tubes as a way to block contraception.

However, the FDA says that they have received more than 5,000 complaints of medical issues, including abdominal pain, fatigue, headaches, and weight fluctuations, by female patients prescribed Essure since its approval. More than 400 women and/or their doctors have reported the coils moving away from the fallopian tubes and into other parts of the patient’s reproductive system.

There have also been reports of five fetal deaths, which occurred when the Essure device failed to prevent pregnancy.

Since its approval, the Essure device has been implanted into approximately 750,000 women. Based on the number of complaints the FDA has received, this means approximated one in every 150 women has had a problem with the device.

The FDA has scheduled a public hearing to be held on September 24, 2015 to review the safety of the product. The hearing will include the agency’s Obstetrics and Gynecology Devices Panel. This hearing is being scheduled due in part to a New York television news channel’s investigation regarding the inconsistencies which took place during the clinical trials of Essure. These trials, which failed to disclose complaints by trial patients, were presented to the FDA in order to get the agency’s approval for the device.

If you have experienced medical complications or other issues from having the Essure device implanted, or any other medical device issues, contact an experienced Westport personal injury attorney to find out what legal recourse you may have for your pain and loss. For a free initial consultation about your case, call Attorney Richard H. Raphael at 203-226-6168 today.

More Top Hospitals Ban the Use of Morcellators for Hysterectomies

May 12th, 2014 at 7:00 am

banned surgical devices, Connecticut medical malpractice attorney, have a hysterectomy, hysterectomies, morcellators, painful fibroid tumors, pre-operative testing, remove fibroid tumors, spread of cancer, surgical device, uterine cancer

Brigham and Women’s Hospital, Massachusetts General Hospital, the Cleveland Clinic, and the University of Pennsylvania Health System have been added to the growing list of prominent hospitals who have suspended the use of a surgical device used in hysterectomies because it can cause the spread of cancer.

Forty percent of hysterectomies are done because of the presence of painful fibroid tumors. The device that these hospitals have banned is a power morcellator, which is used to help remove fibroid tumors during hysterectomies.

The use of a morcellator involves making a small incision near the belly button to remove the uterus. Recovery time is three to five days, compared to four to six weeks when the uterus is removed via conventional surgery.

Surgeons use the morcellator to slice up the fibroids or the entire uterus, thus allowing the tissue to be removed through the tiny incision that was made.

But the Food and Drug Administration (FDA) recently announced the dangers associated with morcellation because the procedure can spread any cancer cells that may be present in the fibroids or the uterus, leaving them behind in the abdomen and pelvic area.

According to the FDA, one in every 350 women who undergo the procedure has uterine cancer which goes undetectable in any pre-operative testing. The spreading of these cancer cells by this procedure significantly decreases rates of long-term survival.

A solution to the issue is to put a bag around the device while the procedure is being performed in order to catch any of that tissue. However, adding the bag would require additional training for surgeons and this could drive up the cost of the procedure.

Studies revealing the dangers of the procedure spreading cancer cells have been around for several years. In 2011, researchers from South Korea presented at a medical conference in Florida their findings of a study they did comparing morcellating tumors or removing them whole. In the group of patients whose tumors were removed whole, 19 percent died within five years. In the group of patients whose tumors were morcellated, 44 percent died within three years. There have been similar results in studies done by studies done in Boston and in Germany.

If you have been left struggling with serious health problems after having a hysterectomy done, contact an experienced Connecticut medical malpractice attorney to find out what compensation you may be entitled to for pain and loss.

Unsterile Medications Recalled

February 21st, 2014 at 12:00 pm

medication recall IMAGEIn late December, Abrams Royal, a compounding pharmacy based in Texas, voluntarily recalled all products produced at its Dallas plant meant for sterile use, according to a Food and Drug Administration (FDA) press release. “Recalled products include injectable medications, intravenous (IV) injections, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments that were distributed between June 17, 2013 and December 17, 2013,” the FDA reports. Because these products are meant for sterile use, patients who come into contact with them face serious risk of infection or injury.

Abrams was made aware of the situation after just one adverse event. A patient in California who received a mineral IV injection “had blood cultures that tested positive for Stenotrophomonas maltophilia, a gram-negative bacterium that can cause many types of infection,” according to the FDA. Such infections range from pneumonia to meningitis.

Howard Skalmberg, director of the Office of Compliance at the FDA said in the statement that patient safety is the agency’s top priority. “Using these products puts patients at an unacceptable risk,” Skalmberg said, “and we urge health care professionals to follow recall instructions issued by the firm.”

It’s not just unsterile medications, such as those recalled by Abrams, which cause infections in the hospital, however. Dr. Peter Pronovost, director of the Quality and Safety Research Group at Johns Hopkins told CNN that about 100,000 people die every year from infections they receive at the hospital. “Take the two most deadly types of infections hospitals give their patients: infections from ventilators and infections from catheters. Together, those kill 65,000 people a year,” he said.

If you or someone you know has been infected while at the hospital in Connecticut—either from faulty or unsterile medications, such as what has been recalled by Abrams, or because of hospital conditions—the most important step is to seek legal counsel. Don’t go through it alone. Contact Richard H. Raphael, Attorney at Law, today.

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