Ollennu & Associates is representing patients who have suffered injuries caused by defective medical devices. Even if medical devices are rigorously tested by the medical device and pharmaceutical companies before being manufactured and released, there are numerous medical devices on the market that can have severe side effects which can cause irreparable harm to patients and even death. For a free, no obligation case evaluation, please complete the form on our website or call us at (860) 218-2122.
Injuries Caused by Defective Medical Devices
Every year, there are a number of medical devices and products withdrawn and recalled from the market due to hazardous defects. At Ollennu & Associates, our defective medical device and medication lawyers can help get the compensation you need to recover if you’ve been hurt due to such a device or product.
Essure Contraceptive Device
The Food and Drug Administration is now requiring the manufacturer of Essure, a contraceptive device, to place black box warning labels regarding the side effects of having this device implanted. Black box warnings are the FDA’s highest warning level and indicate that a product may cause serious injury or lead to death.
Essure is a device used for female sterilization, specifically, a type of tubal sterilization that requires no surgical incision. The device consists of two metal coils that are implanted into the fallopian tubes. The type of fibers used in the metal coil cause inflammation, so that ultimately scar tissue develops around the device and prevents contraception.
Essure was developed by Conceptus Inc., which is now a subsidiary of Bayer. Bayer, as the current maker of Essure, promotes the device as a non-invasive form of permanent birth control that is extremely effective and has a quick recovery time. However, since Essure’s FDA approval in 2002, the FDA has received over 5,000 reports of adverse reactions to the device. This includes 11 deaths, five of which were fetal deaths.
Furthermore, a 2015 study in the British Medical Journal found that women who went through Essure sterilization were more than 10 times more likely to require post-procedure surgery than those who underwent laparoscopic sterilization (tubal ligation).
Serious complications from Essure have been reported to the FDA and other sources, including:
- Unintended pregnancies,
- Ectopic pregnancies,
- Severe pain and bleeding, and
- Migration of device and perforation of organs.
If you have suffered complications due to the implantation of an Essure device, please contact our Firm for a confidential and free case evaluation.
Inferior vena cava (IVC) filters are medical devices implanted in the veins of a patient to prevent blood clots (pulmonary emboli) from moving to the lungs. The inferior vena cava is the largest vein in the body and carries deoxygenated blood from the lower body to the heart and, later, to the lungs. Doctors implant IVC filters into patients in this particular vein to prevent blood clots from traveling to the lungs.
IVC filters have been around since the late 1960s, with retrievable filters FDA approved starting back in 2003. However, since 2005, the FDA has received more than 900 reports of adverse events regarding IVC filters. The majority of adverse events are in regards to filter fracture or migration
These serious adverse events can be potentially life-threatening:
- Device migration
- Filter embolization (heart, lung, liver, kidney)
- Filter fragmentation
- Insertion-site thrombosis
- Perforation of the vena cava
- Recurrent deep vein thrombosis
- Recurrent pulmonary embolism
- Thrombotic complications
- Vena cava thrombosis
- IVC trauma
- Penetration of vessel wall
- Filter infection
An FDA Safety Communication published in 2010 warned about the risk of leaving retrievable IVC filters in a patient for too long and recommended that physicians remove the filter once the risk of pulmonary embolism had subsided. An update to that Safety Communication in 2014 again recommended that IVC filters be removed once the risk had passed, as the longer the filter remains, the greater risk of serious medical complications.
If you have suffered complications due to the implantation of an IVC filter, contact our Firm for a free and confidential case evaluation.
Mirena® is an IUD (intra-uterine device) made by Bayer and approved by the FDA in 2000. Mirena® is a long-term contraceptive (birth control) device that is inserted into the uterus by a doctor. Mirena® is designed to prevent pregnancy in two ways: it releases a progestin known as levonorgestrel which prevents the woman’s ovaries from releasing eggs and if an egg still happens to be released. Mirena is designed to disrupt the joining of the sperm and egg.
Mirena® is the only hormonal IUD that has Food and Drug Administration (FDA) approval. Mirena® prevents pregnancy for up to five years after insertion.
Serious adverse side effects and potentially life-threatening complications have been reported following the implantation of this device. These complications include organ perforation, migration of the IUD to outside the uterus, the expulsion of the IUD, and embedment in the uterus, among others.
Complaint records from the Food and Drug Administration, show there have been 70,072 complaints about the Mirena® IUD since 2000.
Other, more common side effects, include uterine bleeding/spotting at irregular intervals, headache, ovarian cysts, vaginitis, pain during menstruation, pelvic pain, and breast tenderness.
Pharmaceutical companies have a responsibility to adequately warn people of the dangers associated with their drugs or devices. Women who have or have had a Mirena® IUD and experienced complications are encouraged to talk with a medical device Lawyer for a free and confidential consultation.
Morcellator Surgical Device
The morcellator is a surgical tool that has been on the market since 1993. The device is intended to more easily remove large clusters of unwanted tissue by cutting the tissue into very small pieces. However, it has recently been discovered that in many cases not all of the tissue was removed, and instead, that remaining tissue has the ability to relocate to other parts of a patient’s body. In extreme cases, this loose tissue was cancerous and therefore spreads cancer to other parts of the body. These recently discovered cases of cancer in female patients who have undergone surgery during which a morcellator was used has caused the FDA to launch an investigation, and Johnson & Johnson to pull their products from the market.
Some primary dangerous side effects of the morcellator include abnormal tissue grown in the patient. Power morcellation is also linked to the spread of cancer.
Have I Been Affected?
If you, or someone you know, has undergone a myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries) or salpingectomy (removal of the fallopian tubes) and were diagnosed with Sarcoma or other uterine cancer after undergoing this surgery, please contact our Firm for a free and confidential case evaluation.