The Essure System : Evaluating The Contraceptive Device

The Essure System was approved and marketed as a non-incisional approach to permanent birth control by the FDA on November 4, 2002.  The Essure procedure involves placing a small, flexible device called a micro-insert into each of your fallopian tubes.  The inserts are made from polyester fibers and metals (nickel-titanium and stainless steel).  Once the inserts are in place the body tissue grows into the inserts, blocking the fallopian tubes.  Blocking the tubes is intended to prevent sperm from reaching and fertilizing the egg, ultimately preventing pregnancy.

From November of 2002 to present, it is reported that the FDA has received more than 4,000 adverse event reports on Essure and that the original manufacturer has received 16,047 complaints.   Complaints received by the FDA range from symptoms such as naseua, chronic fatigue, hives, abdominal pain, pain during and after intercourse, headaches and abnormal menstrual bleeding to misplaced and protruding coils.  The side effects have been severe enough to warrant surgical removal of the coils or total hysterectomies.

It was reported in April of 2015 that the FDA opened an investigation of the Essure system after allegations that the company falsified and altered medical records during clinical trials, failed to report adverse events, deceived the public and the FDA about the device’s safety and efficacy and used defective materials in manufacturing.  In 2002, Essure was given premarket approval which shielded the manufacturer from product liability and litigation.  If Conceptus violated the conditions of it’s premarket approval, they may lose their protective status.

Click here to contact us to schedule a free consultation to see if you have a case.

At Hudson & Castle, we approach each case ethically, honorably, and skillfully, beginning with a free consultation, continuing with the convenience of flexible appointments, and finally, charging you nothing unless we win or settle. We also handle cases on behalf of our clients who are Delaware residents but have been injured in nearby Pennsylvania. Please call Hudson & Castle at 302-428-8800 (Monday-Friday, 8:30am- 5:00pm, ET) or contact us, and we will get back to you shortly to discuss your case.  

Breast Cancer

According to the Center for Disease Control, each year in the United States more than 2000,000 women get breast cancer and more than 40,000 die from the disease.  Other than skin cancer, breast cancer is the most common cancer among American women.  Less than 1 % of breast cancer occurs in men.  Women over the age of 50 are at a greater risk for breast cancer, but about 11% of new cases of breast cancer in the United States occur in women younger than 45 years of age.  Most women who develop breast cancer have no known risk factors and no family history of the disease, though family history does increase your risk for breast cancer.  Symptoms of breast cancer can include changes to the size or shape of your breast, pain in the breast and nipple discharge other than breast milk, including blood.  A new lump in the breast or underarm is a symptom of breast cancer also.  If you have any of these symptoms, contact your doctor immediately.

The United States Preventative Services Task Force recommends a screening mammogram every two years for women 50 to 74 years of age.  Below are other ways you can reduce your risk of breast cancer.

Click here to contact us to schedule a free consultation to see if you have a case.

At Hudson & Castle, we approach each case ethically, honorably, and skillfully, beginning with a free consultation, continuing with the convenience of flexible appointments, and finally, charging you nothing unless we win or settle. We also handle cases on behalf of our clients who are Delaware residents but have been injured in nearby Pennsylvania. Please call Hudson & Castle at 302-428-8800 (Monday-Friday, 8:30am- 5:00pm, ET) or contact us, and we will get back to you shortly to discuss your case.  

Uterine Cancer

Uterine fibroids are non-cancerous growths in the uterus. They are very common and can cause symptoms such as heavy or prolonged menstrual bleeding, pelvic cramps and frequent urination.  If these symptoms are severe enough, a woman may opt for treatment or removal of the uterine fibroids via hysterectomy or laparoscopic surgery. Though both of these surgical procedures remove uterine fibroids and require an incision in the lower abdomen, laparoscopic surgery uses smaller incisions and requires that the fibroid or uterine tissue be broken down into smaller pieces prior to removal.  Laparoscopic surgery is marketed as being more cost effective, less invasive than an open abdominal hysterectomy and promises a shorter recovery time for the patient.

Until recently, power morcellators, a surgical tool manufactured by Johnson & Johnson, were used to break up the fibroids and uterine tissue intrauterinely prior to laparoscopic removal. After public debate and an FDA investigation Johnson & Johnson, the manufacturers of the surgical tool, pulled the device from hospitals as early July 2014. At one time it was estimated that only 1 in 10,000 women with uterine fibroids were at risk for actually having uterine sarcoma, but after a high profile case in Boston in 2014, the FDA has said that women undergoing surgery for fibroids have a 1 in 350 risk that the growths are actually cancerous.  The process of using this tool to break up fibroid or uterine tissue before removing it laparoscopically has been found to inadvertently spread unknown malignancies and other disease tissue throughout the body.  Before pulling the tool from hospitals, the FDA estimated that it was being used in 50,000 hysterectomies a year not including use during the removal of fibroids.

Click here to contact us to schedule a free consultation to see if you have a case.

At Hudson & Castle, we approach each case ethically, honorably, and skillfully, beginning with a free consultation, continuing with the convenience of flexible appointments, and finally, charging you nothing unless we win or settle. We also handle cases on behalf of our clients who are Delaware residents but have been injured in nearby Pennsylvania. Please call Hudson & Castle at 302-428-8800 (Monday-Friday, 8:30am- 5:00pm, ET) or contact us, and we will get back to you shortly to discuss your case.  

Informed Consent

Doctors must fully inform their patients about the risks involved in any proposed medical procedure, treatment or test. A patient has the right to be informed about the potential risks so that they can decide whether to have the proposed medical procedure, treatment or test. This information must be explained in words that a non-medical person would understand and not just done in writing. The patient must understand these risks as clearly as possible before making their decision. This is what lawyers and doctors term “informed consent.” If a doctor does not get informed consent and a patient is injured the patient may have grounds to sue the doctor for medical malpractice.

Not all risks must be disclosed and the standard for determining whether the risk was important enough to be disclosed can be confusing. Ultimately, it must be proven that the risk was statistically likely enough to have made disclosure worthwhile. In addition, there are times when informed consent is not required, as in emergencies. There may not be time to describe risks involved in a medical procedure that a physician must perform in order to save a life. Medical malpractice law is highly complicated and the law varies from state to state. It is important to involve a highly trained medical malpractice attorney if you suspect your physician was negligent in acquiring your informed consent. Acquiring informed consent is critical to the law of medical malpractice.

Click here to contact us to schedule a free consultation to see if you have a case.

At Hudson & Castle, we approach each case ethically, honorably, and skillfully, beginning with a free consultation, continuing with the convenience of flexible appointments, and finally, charging you nothing unless we win or settle. We also handle cases on behalf of our clients who are Delaware residents but have been injured in nearby Pennsylvania. Please call Hudson & Castle at 302-428-8800 (Monday-Friday, 8:30am- 5:00pm, ET) or contact us, and we will get back to you shortly to discuss your case.  

Birth Injuries

Birth injuries occur to a baby when complications arise during the labor or delivery process.  For every 1,000 babies born in the United States, 5 will be injured during birth.  A birth injury can happen because of an obstetrician’s failure to correctly assess or respond to conditions and/or disorders and complications during a woman’s pregnancy or delivery.  For example, a doctor may fail to recognize a disorder like hypertension during a woman’s pregnancy or he may fail to properly assess the babies overall health in the womb.  The use of an improper medical device or the improper use of a medical device such as a vacuum or forceps can cause a birth injury also.  In these cases, a lawsuit will involve a medical malpractice claim against the physician and/or hospital in which the treatment or delivery took place.

Another common birth injury results during pregnancy when a woman has taken a prescription drug, under the guidance of her doctor or pharmacist.  In this case, you may also have a right to legal compensation from the drug manufacturer and/or pharmacist who assisted you with your prescription.

When a baby is born it can be difficult to determine if a newborns injury was due to a birth injury or defect.  One example is Cerebral Palsy, which is commonly an unpreventable birth defect.  It can also be an avoidable birth injury if the child born was not given enough oxygen during labor.

Unfortunately, complications can arise during delivery and pregnancy which result in permanent injury to the baby.  If harm was avoidable, it is important to protect the legal rights of the baby and parents.

Click here to contact us to schedule a free consultation to see if you have a case.

At Hudson & Castle, we approach each case ethically, honorably, and skillfully, beginning with a free consultation, continuing with the convenience of flexible appointments, and finally, charging you nothing unless we win or settle. We also handle cases on behalf of our clients who are Delaware residents but have been injured in nearby Pennsylvania. Please call Hudson & Castle at 302-428-8800 (Monday-Friday, 8:30am- 5:00pm, ET) or contact us, and we will get back to you shortly to discuss your case.