Over the past decade, nearly 70 million Americans have been implanted with medical devices.

I've been affected by a device I'm looking to learn more about devices

In the first 4 months of 2018, they have been linked to the deaths of 2,368 patients.

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What is a medical device?

Medical devices range from a bandage you would put on a scratch to a pacemaker that would be implanted in your body. They are defined as an instrument, apparatus, machine, implant, in vitro reagent, or such, intended for use in a diagnosis, a cure, a treatment, or a prevention of disease or condition.  A key defining aspect is that a medical device does not achieve its primary intended purposes through chemical action nor by metabolization. Devices are classified as I, II, or III, with Class I presenting the lowest potential for harm (bandages, gloves, and hand-held surgical instruments), and Class III being those that usually sustain or support life, are implanted, or present higher risk of illness or injury (such as heart valves, breast implants, pacemakers, and birth control implants, such as Essure).

Source

ivc filter

ivc filter

IVC filters

An inferior vena cava (IVC) filter is a small metal device designed to stop blood clots from traveling into the lungs, and possibly causing a pulmonary embolism.

hernia mesh

hernia mesh

Hernia Mesh

Surgical mesh is a flexible sheet made of plastic or organic materials used to reinforce or repair week tissue, with hernia repair surgery being the most common application.

hip replacement

hip replacement

Metal-on-metal hip replacements

A hip replacement is a surgical procedure in which the hip joint is replaced by a prosthetic implant. Although a fairly common procedure, adverse reports have noted problems such as loosening of the implant, fractures, and avascular necrosis (“bone death”).

davinci robot

davinci robot

da Vinci Surgical Robot

The da Vinci Surgical System has been used to help surgeons perform complex, minimally invasive surgeries on more than three million patients worldwide. 

transvaginal mesh

transvaginal mesh

Transvaginal Mesh

Transvaginal mesh is a net-like implant used to treat pelvic organ prolapse and stress urinary incontinence in women. It can cause various severe complications such as severe pain, nerve damage, tissue erosion and organ perforation. To date, more than 40,000 lawsuits have been filed against Boston Scientific, one of the device manufacturers.

breast implant

breast implant

Breast Implants

Breast implants are one of the most common medical devices, with over 300,000 women undergoing breast augmentation per year in the United States and more than 50,000 breast cancer patients getting breast implants after mastectomy. However, thousands of women have claimed adverse events with silicone and saline implants - from pain and infection, to severe autoimmune symptoms, and even a rare cancer of the immune system called ALCL.

essure

essure

Essure

Essure Permanent Birth Control System is a prescription-only, non-hormonal form of permanent birth control for women. Although its manufacturer Bayer AG insists that it is 99.83% effective, tens of thousands of women have claimed the device has caused life-changing and life-threatening injuries. It is estimated that over 16,000 lawsuits have been filed against Essure.

As of July 20, 2018, Bayer has pulled Essure from American markets, with a plan to discontinue its sales completely after December 31 of this year.

ct scan

ct scan

CT scan

A computerized tomography (CT) scan combines a series of X-ray images taken from different angles around the body, using computer processing to create cross-sectional images inside the body.

One
in
Ten
Americans will be implanted with at least one device over their lifetime.
The overwhelming majority of high-risk implanted devices never require a single clinical trial.

“We won't stop. They've already taken away my health. What else can they take from me? I have nothing to fear from them.”

Angie Firmalino founded Essure Problems, a 36,000+ strong patient advocacy group, that now brings together patients and activists together fighting for medical device safety.

Through her personal story and the forming of the E-Sisters, Angie has propelled forward the fight to remove Essure off the American market, with Bayer finally announcing on July 20, 2018 its plan to pull the device from American markets. You can watch Angie's story in The Bleeding Edge documentary, on Netflix.

Questions & Answers

I’ve been harmed by a device. What can I do?

• Contact doctor to discuss the cause and next steps.

Report an adverse event to the FDA (you may learn how to make a report with the Med Watch tutorial.)

• Research your device on the Find a Device page of this site

• If you need to have a device removed and are in need of a physician to do so, you may contact the patient groups listed on the Find a Device page of this site.

My doctor is recommending a device. What questions should I ask?

• How many procedures have you done?

• Have any patients had problems?

• Have you ever removed this device?

• Has this device ever been recalled?

• What are the risks and alternative treatments?

• Does this device have a black box warning or contraindications?

• What is the device made of, and what can be done if an adverse reaction to the materials occurs?

• Have you had any financial relationship with the manufacturer of the device you’re recommending?

How can I learn more about a particular device?

• Research specific device recalls.

• Look up the device on the Find a Device section of this website

How can I find out if my doctor has received money from device manufacturers?

You may find out if any of your doctors have received money from device companies at ProPublica’s Dollars for Docs.

How can I find out if my doctor has been sued before?

• You may research if your doctor has been sued by using the doctor’s name as a keyword in your search engine, along with key terms such as “malpractice,” “lawsuit,” or “complaint.”

• You may also use the AIM DocFinder, which will provide information on a physician’s licensing background and disciplinary information.

How can I research my doctor’s or surgeon’s experience with medical devices?

You can learn more about your surgeon’s experience before your procedure at ProPublica’s Surgeon Scorecard.

I have a device that hasn’t caused me problems. Should I get it removed?

Many medical devices are lifesaving and very safe to use. Removing a device that’s functioning well may cause unnecessary harm. If you are concerned about your medical device, please consult your physician.

I’m a doctor. How can I support medical device safety?

• Report medical device adverse events to the FDA via MedWatch.

• Encourage your hospital or practice to join a patient safety membership organization, such as the Institute for Healthcare Improvement/National Patient Safety Foundation’s Stand Up for Patient Safety Program.

• Follow the latest data on medical technology, adverse events, and recalls on the Device Events database.

• Become an Unbranded Doctor and join the National Physicians Alliance’s network committed to reducing the influence of pharmaceutical marketing in the field.

• Support the Medical Device Safety Act.

• Learn more about the Unique Device Identification (UDI) initiative and how it can help ensure device safety by reading the Pew Charitable Trusts’ report.

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