Doctor’s Tip: Medical devices are poorly regulated, can cause harm
Medical devices range from robots that perform surgery to lens implants, cardiac stents and pacemakers. The medical device industry is a $300-billion-a-year industry, that has even more influence in Washington than Big Pharm — in 2017 they spent $64 million on lobbying. A few weeks ago, there was a showing at Paepcke Auditorium in Aspen of a recently-released documentary available on Netflix, called “The Bleeding Edge.” The director, Kirby Dick, was there for an interview and Q and A after the showing. The film is about the poor regulation of the medical device industry, and how this is causing harm to patients.
Most people, including doctors who recommend or use medical devices, assume that the FDA uses the same scrutiny for these devices that it does for pharmaceuticals. However, that’s not the case — many new devices that come on the market haven’t been proven to be effective or safe in humans. Following are four examples from “The Bleeding Edge” that illustrate the problem.
Essure is a small metal coil used for female sterilization. The coil is placed in women’s fallopian tubes in an office setting — it induces scarring, which prevents sperm from entering the tubes. The device was developed by Conceptus, which was later bought by Bayer. It was approved by the FDA in 2002, based on short-term studies of fewer than one or two years, even though it was intended for lifetime use. In the last several years, thousands of women have complained of side effects, including perforations of their tubes, chronic pain and bleeding sometimes leading to hysterectomies, plus hundreds of unintended pregnancies. One of the problems with this device is that in some women it causes an autoimmune response, which results in several other symptoms including headaches and feeling crummy. Many Essure devices have had to be removed, although removal is difficult (you can’t just pull it out when scar tissue has formed). In July of this year, Bayer finally announced it would halt U.S. sales by the end of the year. In the meantime, Bayer is paying out millions of dollars for lawsuits, but is still making billions of dollars by continuing to sell the product.
There are several types of hip replacements, including metal-on-metal cobalt devices. An orthopedist in Alaska was featured in “The Bleeding Edge,’ who had this type of replacement himself, and later developed multiple symptoms, including brain fog, and eventually a complete mental breakdown. His blood level of cobalt was 100 times the normal limit. The joint replacement was removed — with difficulty — and replaced with another type of device. Within a month his symptoms resolved. There are 10 million people worldwide with cobalt hip, knee and shoulder replacements, and it turns out that many of these people are suffering from similar symptoms. Problems have also occurred with cobalt-on-polyethylene implants. If you have a cobalt-containing implant, have your blood cobalt level checked periodically.
Polypropylene mesh has been used for years for hernia repairs, and in recent years it has been marketed under the brand name Prolift by Ethicon, a subsidiary of Johnson and Johnson, for pelvic floor laxity in middle-aged and older women — often related to the trauma of childbirth. It costs $25 to make, but is sold for $2,000. It was introduced in 2005, bypassing FDA scrutiny due to being similar to the previously approved hernia mesh. Prolift causes an inflammatory response and scarring, and as the scar matures the tissues with which it comes in contact contract, creating a “rigid, hard object” around the vagina, bladder and urethra (the tube urine passes though as it exits the bladder). Many women who underwent this procedure started complaining of pain and other symptoms. Their complaints were brushed off by doctors, but eventually complaints became severe and numerous enough that they could no longer be ignored. Unfortunately, it’s essentially impossible to remove all the mesh in a patient with complaints, due to scar tissue in and around it. According to the documentary, the surgeons who developed prototypes knew there were problems, but marketing was already underway, and “marketing won out over science.” Currently, Johnson and Johnson has been hit with $300 million in lawsuits, but keeps marketing their product because of $683 billion in profits.
The Da Vinci is a robotic surgical system that costs $2 million, made by Intuitive Surgical. It was cleared by the FDA in 2000, and is used for operations such as prostatectomies and hysterectomies. There is a long learning curve for surgeons wanting to become adept at using this technology, and when the Da Vinci first came out, two weeks of intense training was promised for each surgeon who was going to use it. Within a short time, the training was reduced to two days, and the company’s reps pushed surgeons into using the technology before they were proficient. One surgeon in the film, who is an expert in robotic surgery, stated that it took him 200-300 procedures before he felt proficient. Serious complications have occurred using the Da Vinci System, including vaginal cuff dehiscence in gyn procedures — where closure of the incision at the top of the vagina following a hysterectomy fails, in some instances resulting in women’s intestines falling into and protruding from their vaginas. Of note is that robotic surgery is more expensive, takes longer, and has poorer results than traditional surgery.
The film makes the following suggestions for protecting yourself before someone puts a medical device in you or when a surgeon suggests robotic surgery: (1) Do your own research on the device. (2) Get a second opinion. (3) Find out how many procedures the surgeon has done. (4) Have a patient advocate come with you to your appointments. (5) Go to openpaymentdata.cms.gov to see if the surgeon has a financial interest in the recommended medical device. (6) Keep in mind that new, cutting edge technology isn’t necessarily better. (7) Realize that surgeons often have cozy relationships with medical device reps, who influence their recommendations.
Medical devices such as pacemakers for serious cardiac rhythm disturbances, and stents for a heart attack, can save your life. But some medical devices can make you sick and even kill you. These devices all need to be proven to be effective and safe before they are used in humans, and physicians using them need to be properly trained.
Dr. Feinsinger, who retired from Glenwood Medical Associates after 42 years as a family physician, has a nonprofit Center For Prevention and Treatment of Disease Through Nutrition. He is available for free consultations about heart attack prevention and other medical issues. Call 970-379-5718 for an appointment. For questions about his columns, email him at firstname.lastname@example.org.