FDA Strengthening Warnings on Essure

Posted by Terry Boyd on April 8, 2016 | Categories: Class Action Post

For women who seek sterilization, usually, surgery is the main option. Bayer tried creating a permanent form of birth control through the Essure device. The device, called Essure, is manufactured by Bayer and is a permanent and non-reversible form of birth control. But it has dangerous health risks that the FDA now recognizing.

In early March, the Food and Drug Administration (FDA), announced that the device would have to be packaged with a stronger warning about possible complications. The announcement came after some 5,000 reports of complications, including chronic pain, bleeding, and allergic reactions.

The birth control method is to be used by women who no longer want any children. The FDA reports that when inserted correctly, the device has less than a 1% chance of becoming pregnant. The device requires no surgery – a woman’s doctor can insert the device into a woman’s vagina, through her cervix, and up into her fallopian tubes. Once there, scar tissue begins building up around the device and after time, the sperm can no longer pass through to fertilize the egg.

The FDA states that it still considers Essure an appropriate method of birth control for women who no longer wish to have children. However, serious problems and side-effects have been reported by women who have had the device implanted. These included persistent pain, abnormal bleeding, allergic reactions. Some other complications included perforation of the uterus or the fallopian tubes.

The FDA is requiring that a stronger warning must be placed on the packaging for the device. They are also requiring that doctors go over a checklist with their patients to determine risk factors. Women will have to undergo testing three months after Essure is implanted, making sure that the device is placed correctly. In addition to these actions, the FDA is also requiring that Bayer conducts additional studies looking into the risks of unplanned pregnancy and other complications.

If you have suffered an injury or another adverse health event due to the implantation of an Essure device, you may be entitled to compensation. Contact the law offices of John Foy & Associates. The “Strong Arm” attorneys will help you get the compensation you deserve. Contact us today.

Nearly $1 Billion in Settlements and Verdicts

$75,000 While traveling North on GA 92, our client Q.E. was struck in the rear while slowing for traffic. Our client suffered back injuries.

$100,000 While traveling on US Highway 80 at Ladonia Drive our client W.C. was struck by a vehicle failing to yield the right of way. Our client was transported by CARE Ambulance to Columbus Medical Center with severe injuries.

$100,000 Our client R.S. was a passenger in a vehicle traveling West Bound on Akers Mill Road at Powers Ferry Road when a Dodge Dakota turned left in front of the vehicle causing a collision. Our client was transported by Metro Ambulance to Southern Regional with back injuries.

$100,000 While traveling South on GA 61 South of Rock Creek Drive a truck exited the Murray County Landfill turning into the path of our client E.G. upon impact the truck spun striking our clients vehicle sending her off the left side of the roadway where she struck a guardrail with her front-end coming to an uncontrolled rest. Our client was transported by ambulance with multiple injuries where immediate surgery was necessary.

$105,000 Our client S.W. was a passenger in the rear seat of a vehicle that was traveling Northwest on North Druid Hills Road entering the intersection at LaVista Road. The driver of the vehicle veered out of its lane leaving the roadway as it was exiting the intersection the vehicle struck a traffic light pole, which spun the vehicle around coming to a final rest. Our client was seriously injured and was transported to Grady Memorial Hospital.

$125,000 While traveling North Bound on Burnt Hickory Road a van pulled into our clients J.R.’s lane causing an immediate impact. Our client was transported to Cartersville Medical Center with injuries to the lower extremities.

$128,500 While traveling East on Highway 138 an SUV turned directly in front of the vehicle in which our client D.C. was a passenger. Our client was transported by MED 5 to Atlanta Medical Center with chest, back and leg injuries.

$150,000 While stopped at a red light waiting to turn left at 10th Street and Monroe Drive our client D.W. was struck by a tractor trailer that was turning right onto Monroe Drive. The tractor trailer’s left rear side struck our clients vehicle on the right side. Our client suffered shoulder and lower back injuries.

$174,000 While traveling North on Highway 92 our client S.P. slowed down for a vehicle turning left onto Seay Road and was struck in the rear from behind by a vehicle that was traveling at a high-rate of speed. Our client S.P. was transported by MEDIC 42 to Piedmont Fayette Hospital with injuries.

$200,000 When traveling on Peachtree Industrial Boulevard our client E.A.’s vehicle broke down at the intersection of Jones Mill and Peachtree Industrial Boulevard. Our client E.A. exited the vehicle and was standing next to it when at a high rate of speed a vehicle came from behind swerving and struck our clients body. Our client was transported to GMC Lawrenceville for injuries.

$225,000 While our client C.L. was driving in the center lane a tractor trailer attempted to change lanes into the center lane striking our client. Our client was treated for injuries.

$225,000 While traveling North on Hickory Flat Highway our client J.P. stopped from traffic and was rear-ended by another vehicle. Our client suffered neck and back injuries.

$250,000 While traveling as a passenger South on Helen Highway a vehicle turned in front of the vehicle that our client B.W. was a passenger, pushing the vehicle into a stopped car. Our client was transported by ambulance to NE Georgia Medical Center with shoulder and abdominal internal injuries.

$250,000 While traveling North on Georgia 61 in the left lane our client J.H. was struck by a vehicle turning left that pulled out into his path. Our client’s vehicle rotated approximately 180 degrees counterclockwise and then backwards approximately 99’5” before traveling onto the East shoulder coming to a rest facing West. Our client was transported by Emory Life Flight with multiple internal injuries.

$265,000 While traveling on 285 North, our client K.H. was struck by a vehicle spinning out of control. Client suffered shoulder and neck injuries.

$270,000 While traveling South on GA 87, our client stopped to make a left turn. Upon stopping, a tractor trailer traveling behind was unable to stop striking our client in the rear. After impact our client came to an uncontrolled stop South of the impact area. Our client was transported by EMS Air to Macon Medical with Spinal Injuries.

$280,000 While traveling EB on Upper Riverdale Road our client was stopped at a light that had turned red. Upon stopping our client was rear-ended by a tractor trailer. Our client was transported to Southern Regional Medical Center due to head, neck and back injuries.

$300,000 While traveling East on I-20 in the middle lane a vehicle merged left into our client E.D.’s vehicle causing him to swerve left losing control, hit another vehicle and a guardrail. Our client was transported by Life Flight to Atlanta Medical Center with multiple injuries.

$300,000 While traveling N on SC187, our client was a passenger in a vehicle that had stopped for traffic and a vehicle that was driving too fast for conditions swerved and hit the vehicle in which our client was a passenger. Our client was transported by ambulance to AnMed Health Emergency Department with injuries to her head, neck, shoulder and ankle.

$300,000

Our client B.W. was driving East Bound on Honey Creek Road passing through the intersection at I-20 when a vehicle pulled out of a parking lot at the corner of the intersection and struck our client’s vehicle. Our client suffered back injuries that required surgery.

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