Product Liability

Power Morcellator: Clearly not a Safe Device

Posted by on Oct 15, 2014 in Injury Law, Product Liability

Research from the National Institutes of Health has concluded that majority of the women in the United States will need to undergo a hysterectomy before they reach the age of 60. This surgical procedure is performed to remove a part of the whole uterus (or the womb) due to serious health conditions, such as uncontrollable vaginal bleeding, chronic pelvic pain, presence of oversized uterine fibroids (or myomas), infections, cervical cancer, ovarian cancer, uterine cancer, uterine prolapse (a condition wherein the womb or the uterus slips out of the cervix and drops halfway into the vagina or birth canal), endometriosis (which causes pain during or after sex, bleeding between periods, severely painful periods, and so forth), heavy, painful periods due to adenomyosis (this happens when the tissues lining the uterus grow inside the uterus walls instead), and pelvic inflammatory diseases.

There are different ways through which hysterectomy is performed:

  • Abdominal hysterectomy or open surgery: This traditional way of performing the surgical procedure requires an incision (can be vertical or horizontal, which is along the bikini line) on the abdomen that is five to seven inches long. It is a major surgery that is performed under general anesthesia and which necessitates a 6-week recovery period.
  • Vaginal hysterectomy: Instead of making a cut on the abdomen to remove the uterus from there, the incision (a smaller one which is stitched up afterwards) is made on the vagina itself to remove the uterus or the organ that causes the health problem.
  • Laparoscopic (or minimally invasive) surgery: This particular procedure requires about three to four 0.5 – 1cm incisions where instruments, such as a laparoscope and a morcellator need to be inserted. A laparoscope is a thin telescope-like instrument that is used to see inside the woman’s body to guide the cutting, or morcellation, of the uterus and other organs that need to be removed. A morcellator is a device that cuts or minces uterus and other organs into fragments tiny enough to be suctioned outside the body.

Morcellators were introduced in the early 1990s; but these gained immediate acceptance in the medical field as these allowed doctors to perform hysterectomies and myomectomies (the removal of uterine fibroids) faster, safer, more accurately, and with lesser pain and blood loss. Johnson & Johnson, particularly, was one of the giant companies that released its own models of power morcellators – the Gynecare X-Tract, the Gynecare Morcellex and the Morcellex Sigma. Despite the benefits offered by these devices, in general, and the even better benefits provided by the J&J models, in particular, a notice that discouraged doctors from the further use of these devices in laparoscopic surgeries was still issued by the US Food and Drug Administration after reports were made about the devices causing the spread of uterine sarcoma, an undetected deadly cancer tissue, beyond the uterus.

In the safety communication notice it released on April 17, 2014, the FDA also advised doctors not to use the power morcellator in women suffering from uterine cancer, besides persuading them against the use of the device on those with uterine fibroids as this can likely threaten a woman’s long-term survival.

Private morcellator lawsuits have already been filed in different courts in the US and the many women who had been treated with a power morcellator in the past and who might now be suffering from cancer are encouraged to seek legal counsel to know what options they have.

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Sertraline – The Most Prescribed Anti-depressant Drug in the US

Posted by on Feb 22, 2014 in Product Liability

Selective serotonin reuptake inhibitors or SSRIs, a certain class of drugs that have earned high recognition due to their effectivity and safety, has been the most frequent content of prescriptions issued to treat problems of depression and various forms of disorders.

SSRIs increase the performance of serotonin or neurotransmitters, the chemical that enables the nerves within the brain to communicate with one another. Neurotransmitters are produced, released and re-absorbed by the brain; SSRI drugs are developed to prevent the brain from re-absorbing neurotransmitters, allowing more of them to stimulate the nerves of the brain to enable changes and improvement in the mood state of the patient.

Besides treating depression, SSRI drugs have also been used to treat major depressive disorders, panic disorders, anxiety disorders, social anxiety disorders, eating disorders, obsessive–compulsive disorder (OCD), posttraumatic stress disorder (PTSD) and chronic pain.

One of the drugs in the SSRI class is the generic drug called Sertraline (the brand name of which is Zoloft). In 2011, exactly 20 years after the medicine was introduced by Pfizer and approved for distribution in 1991, Sertraline became the number two most prescribed medicine to treat depression, with more than 37million prescriptions. Furthermore, a comprehensive study involving Sertraline and 11 other anti-depressants gave results that Sertraline is one of the most effective and accepted medicines in treating unipolar major depressions in adults.

The many SSRIs have known side effects, including muscle rigidity, confusion, high fever, sweating, fast or uneven heartbeats, dizziness, nervousness, insomnia, nausea, skin rash, headache, diarrhea, loss of appetite, abnormal ejaculation, loss of coordination and shallow breathing. Males, who use the drug, sometimes experience prolonged erection that lasts for four hours or more. Experiencing any of these symptoms would be an indication that you will have to inform and talk to your doctor about the possibility of either stopping or still continuing with the intake of this medication.

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