Former Roanoke news anchor fights to change laws following tough medical journey

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WASHINGTON, DC (WDBJ7) Frances Scott found her calling in front of the camera.

Frances Scott

Whether she was sitting behind the anchor desk or covering stories from the field, Scott says journalism was her life's passion.

"I'm really curious," Scott said with a smile. "I love writing and I love people, so it was just the perfect career for me."

In the span of 15 years, Scott reported or anchored for every television station in the Roanoke/Lynchburg area. She got her start at WDBJ7.

"That was where I did my first internship with Jean Jadhon, Connie Stevens, Scotty Ayres and so many people that everyone knows," said Scott.

After years of working her way up the ladder, Scott accomplished the dream of many in television news: landing a high-paying job in a large city. For years she was a main anchor at television station WTVD in the Raleigh/Durham area of North Carolina.

"I was our main anchor in Raleigh," said Scott. "I was very happy."

There was a lot to be happy about. She had three children and a home on a lake. Her work was recognized with an Emmy.

But quietly she was suffering with pain, slowly growing in her hips.

"I went to a couple of orthopedists and they said we see that maybe you were born without sockets," Scott explained.

Scott loved being active, running, dancing, and playing every sport she could, but she was living with a hip abnormality that caused extreme physical activity to slowly wear down her joints.

Doctors compared her hips to a set of tires, running on a car that was out of alignment.

"Your tires had bad alignment and then you put high miles on them, and they're worn out," said Scott.

Losing the ability to do the things she loved, Scott made a tough decision in 2011. At the age of 39, she underwent a double hip replacement.

Surgeons installed a product called "Pinnacle with ULTAMET liner," metal-on-metal hips manufactured by DePuy Orthopedics.

"I wanted my life back and most of the surgeons said you will get your life back," said Scott.

Scott filed a Federal lawsuit against DePuy Orthopaedics in 2014, claiming she suffered "loss of mobility," along with "physical pain and mental anguish" as a result of her surgery.

"My first inclination that anything was wrong was when I went back to physical therapy," Scott said. "My physical therapist asked if anything was wrong and I said 'well, it was pretty bad. I actually had to take the stronger pain killers. She stopped and said 'Oh, you shouldn't need those at this point."

In her Federal complaint, Scott said that after her surgery, friction and wear of her metal hip liner caused large amounts of cobalt-chromium to enter her blood and tissue, causing "severe pain and discomfort."

"I started not wanting to leave the house and I had a lot of shame about why I wasn't doing well," Scott said.

On its website, the Food and Drug Administration says there's a risk of metal ions, like cobalt and chromium, entering the bloodstream of patients with metal-on-metal hip implants.

"Different people will react to these metal ions and particles in different ways," reads the FDA's online statement. "At this time, it is not possible to predict who will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be."

Johnson & Johnson and DePuy Orthopedics pulled their "Pinnacle with Ultamet liner" from the market in 2013, two years after Scott's surgery.

In an statement to WDBJ7, a spokeswoman for DePuy said "The decision to discontinue ULTAMET Metal-on-Metal was not related to safety," adding "ULTAMET Metal-on-Metal is backed by a strong record of clinical data showing reduced pain and restored mobility for patients suffering from chronic hip pain."

One year after her surgery, Scott left television news.

"I tried to go back to work and it just didn't go well," Scott said. "I hurt all the time and I just realized I can't do this. We didn't know what was wrong, so I thought 'I need to just double down, quit work, and really focus on physical therapy."

Scott underwent a second surgery, five years after the first, to remove the Pinnacle with ULTAMET product. Today, she lives in Texas, where her life has taken on a new focus.

"I can't get my career back, my life savings, or my house, but I'm interested now in preventing this from happening to anyone else," Scott said.

Scott is working with others who suffered complications from medical device implants to lobby for change. Last week she traveled from Texas to Washington to speak directly with lawmakers.

She wants the Food and Drug Administration to give medical devices the same scrutiny pharmaceuticals receive before they're allowed to be sold in the United States.

"How medical devices get to market is wildly different than how drugs get to market," said Scott.

DePuy told WDBJ7 "Our medical devices undergo extensive laboratory testing before they are submitted to government health experts for a science-based review, and we continue to analyze information such as clinical data and adverse event reports once a device is on the market."

At one time she made a living by telling other people's stories. Now, Scott says she's getting back to living, by telling a story of her own.

"This will hurt people for generations if we don't get this fixed," said Scott.

Full Response From DePuy Orthopedics

At DePuy, we have no greater responsibility than to the patients who use our products. ULTAMET Metal-on-Metal is backed by a strong record of clinical data showing reduced pain and restored mobility for patients suffering from chronic hip pain.

ULTAMET was designed and developed in conjunction with experienced orthopaedic surgeons and leaders in the biomedical field in response to a clinical need for a hip bearing surface that reduced the risk of dislocation and was more durable than the polyethylene available during most of the 1990s. Surgeons, scientists, engineers and academics drew on years of experience in developing a new generation of metal-on-metal bearings. In the 2000s, various orthopaedic device manufacturers developed and marketed many different metal-on-metal bearing options.

ULTAMET® Metal-on-Metal Articulation has been thoroughly tested over more than a decade, undergoing dozens of tests to better understand how the implant would wear, the implant’s strength, and other important performance characteristics. ULTAMET Metal-on-Metal was also used in two FDA-supervised clinical studies for other products that went through the pre-market approval (PMA) process and ULTAMET demonstrated excellent results in both clinical studies. Tens of thousands of patients have benefited from having metal-on-metal hip replacements and continue after ten years or more to enjoy increased mobility and relief from pain.

Still, all surgical procedures and implanted medical devices involve risks, and a discussion between a doctor and patient to weigh those risks versus the benefits is a critically important part of any pre-surgical process. When surfaces of a hip replacement rub against each other, there are changes happening at a microscopic level, including tiny particles wearing away. No matter what materials are used, these implants experience wear over time and generate what are called wear particles that are released into the area surrounding the implant. While we empathize with any patients who experience complications, for most patients the body’s natural defenses harmlessly respond to the particles by isolating or eliminating them from the body. For some, the wear particles might cause a reaction that results in symptoms in the area surrounding an implant, such as fluid buildup or tissue damage. In these cases, further surgery can be required. This is true for all types of implants, regardless of the materials from which they are made. Health effects beyond the hip joint have rarely been reported in metal-on-metal hip implant patients.

After ULTAMET and other metal-on-metal bearings were introduced, bearing technology continued to advance and physician preferences shifted toward newer polyethylenes that were available in the 2000s and to ceramic-on-ceramic bearing combinations. As a result, ULTAMET Metal-on-Metal was discontinued in 2013 based on low demand for the product, the availability of alternative options that meet the clinical needs of patients and a proposed change in FDA regulation of all metal-on-metal total hip replacement products. The decision to discontinue ULTAMET Metal-on-Metal was not related to safety or efficacy.

We stand behind the safety of our devices, which have benefited millions of patients who continue to find relief from the debilitating conditions that necessitated them to undergo surgery. Our medical devices undergo extensive laboratory testing before they are submitted to government health experts for a science-based review, and we continue to analyze information such as clinical data and adverse event reports once a device is on the market. We believe a balanced regulatory system with the authority and resources to independently assess information related to safety and effectiveness is important and the Johnson & Johnson Family of Companies are open to the continuous improvement of the medical device regulatory system.