A Food and Drug Administration advisory committee has convened to
reinvestigate the risks and benefits of using Essure, the only non-surgically implanted birth control device
currently available in the U.S.
Essure is a small metal and polyester coil that is implanted in a woman’s
fallopian tubes to create permanent sterility. Essure users have complained
of side effects including pelvic swelling and pain, dizziness, weight
gain, and fatigue. Bayer Healthcare Pharmaceuticals, the company that
manufactures Essure, maintains that the device is safe and that only a
small percentage of users suffer ill effects.
The expert panel is reviewing evidence and testimony and will make a recommendation
to the FDA regarding whether Essure should be recalled. The FDA is not
required to comply with the committee’s recommendation, but has
often followed other panels’ recommendations.
A medical device is an instrument or machine that is used to treat or diagnose
a medical condition. Common medical devices include hip or knee replacements,
pacemakers, stents, surgical mesh, pain pumps, and other implants.
Unfortunately, some medical devices have dangerous design or manufacturing
defects. These defects can cause side effects or complications, or can
even worsen the very conditions they were designed to treat. They can
also result in a need for further surgeries to correct the problems or
to remove the devices.
The FDA and Manufacturers
Before any medical device goes on the market, it must first go through
a period of testing and be
approved by the FDA. However, after it has been approved, the manufacturer has the responsibility
to keep it safe. Just as with any other product, things may go wrong during
the manufacturing process, and dangerous defects can occur that can put
patients at risk of injury. The manufacturer has the ultimate authority
to ensure the safety of the device and will be liable for injuries caused
by using a defective device.
When a device is found to be faulty, the manufacturer has the responsibility
to inform the FDA and the public of the defect and to recall the device.
If it does not do so, it will be liable for any injuries or deaths occurring
as result of use of the defective device.
Expert testimony is important in cases involving defective medical devices.
Because of the level of specialized technical knowledge required to understand
the workings of medical devices, expert witnesses are generally needed
to demonstrate that the device is, in fact, defective. Additionally, if
a person is injured by a faulty medical device, he or she must prove that
the device’s defects caused the injuries. This can be a complex
task, so medical experts are used to show causation.
Statute of Limitations
Often, symptoms caused by a defective device only appear after some time
has passed since the device was implanted. The
statute of limitations for medical malpractice or medical product liability claims is the later
of five years after the injury occurred, or three years after the patient
discovers the injury. This means that if a patient’s reaction to
the device is delayed, the patient has three years after symptoms appear
to file a medical malpractice claim.
Charles County, MD Personal Injury Lawyers that Fight for You
If you have suffered an injury because of a defective medical device, an
attorney can help you formulate your claim and protect your rights. Please
contact the Law Office of Robert R. Castro to schedule a free initial consultation.