Lessons from the Mountain

by Mary McDonough

  In 1963, Dow Corning had begun selling small, gel-filled bags that were believed to be biologically inert for use as breast implants. Within a few years, surgeries to implant the device were one of the most popular kinds of plastic surgery. What patients didn’t know for decades—I among them—was that the “safety” testing had been limited to short-term studies on very small groups of animals. Since implants were for many years classified as medical devices and not pharmaceuticals, they had not been subjected to the rigorous testing and follow-up reporting that would have provided consumers and doctors with adequate information for informed decisions. Finally, in 1991, the devices were reclassified, but the damage was done.

  In 1974, John’s wife, Colleen, had the implants and they ruptured. The gel migrated into her system and she developed burning pain, debilitating weight loss, and chronic fatigue, among other ailments. Colleen’s medical bills averaged $50,000 a year. His own wife’s illness, stories in the press about other women made sick by the devices, the increasing evidence that Dow Corning had known about possible problems with the silicon gel, made John consider leaving the company. But he was so close to retirement, he and Colleen decided he’d stay. John did advise Dow Corning they should withdraw the devices from the market until proper testing could be done, but they refused, claiming the move would be construed as admission the claims were true. In 1993, Colleen settled with Dow Corning; and three months later, in August 1993, the day he became eligible for retirement, John Swanson left the company.

  Now considered a whistle-blower, John was at the press conference encouraging education and research, and lending his expertise to our fight.

  We presented some of Dow Chemical’s own studies with a time-line showing what facts Dow Chemical knew, and when. For example, there was the “cockroach study.” Cockroaches were placed in a petri dish containing silicone, and not one cockroach that crawled out lived long enough to crawl more than a few inches away from the dish. Dow has a pesticide division, so you do the math.

  The information was explosive, and the pressroom was packed. I was proud to have the forum to speak, to be part of something purposeful. The last ten years of my life had been sidelined with strife and illness—this was something positive. It was groundbreaking for me, a little scandalous to challenge authority; and it was not just a director or my parent, this was a big company.

  After the press conference, we gathered in the offices to await any press requests and see if there was any feedback to the news. Indeed, there was quite a bit of coverage, and a flurry of phone calls disputing our claims started pouring in.

  John Swanson looked at me and said, “Well, I guess you just moved up the list.”

  “What list?” I asked.

  “The Dow enemy list.”

  I stared at him, my mind racing. I had heard about a list Dow Corning’s PR firm had apparently made of the people, listed in order of grievance, who had publicly challenged them on implants. I thought John was joking. “Oh no, I’m not even on the list. There’s nowhere for me to move.”

  He looked at me. “Oh, you’re on the list. The minute you came out in that People magazine article, you were on the list. You just moved up a lot today.”

  I still wasn’t even sure it even existed, but I realized I had probably pissed a lot of people off that day. I had a daunting feeling in my gut. I sat back, my heart heavy with the realization I had just taken my first step into the minefield. Well, I was in; somebody start the music.

  Now, I know you’ll think this is crazy and paranoid of me, but after that day, my phone suddenly developed an eerie clicking sound during conversations. This clicking continued for years. My friends got so used to it, we started to talk to whoever may have been “listening.” On the count of three, we would curse Dow. Just in case they were listening!

  MY MENTOR

  When I was going through my surgery recovery and public stumbling, Sybil Niden Goldrich took me under her wing, and I have been there ever since. She has been my hero and a leader for all women who have had implants. Sybil was the consumer’s whistle-blower and led the charge on the dangers of implants.

  Sybil had breast cancer, and she had terrible experiences with her own implants after mastectomies. She founded Command Trust Network in 1988, a clearinghouse of information about implants—all of which had been difficult, if not impossible, to find because of the secrecy and lies surrounding the industry. She was instrumental in getting implants taken off the market in 1992, until more research could be done on their safety. She blew the lid off the secrets and raised public awareness that implants had been on the market for years without FDA approval. (Now they have been approved, but I’ll get to that fiasco later.) She is a champion for so many women and has led the fight for over twenty years.

  I met Sybil when I was thirty-two. She became a touchstone for me in all things, and soon became a close friend as well. I went to her after my first experience in D.C. and told her I was worried about the list and the clicking. She said in her calm, knowing way, “Don’t worry. You know whose name is first on that list? Mine.”

  Sybil’s experiences were immortalized in a Lifetime MOW entitled Two Small Voices, a powerful story of her early experience with implants and her efforts lobbying for better research and consumer information. She is a survivor and one of the most incredible people I have ever known. She helped me develop a stronger voice, and we have battled through many hearings, giving our testimonies, and attending FDA meetings, rallies, protests, and citizen lobby days together. She is a silver lining to this experience.

  CAPITOL STEPS

  My next press conference was harder in some ways because it had a larger press response. I was again headed to the nation’s capital, this time the Capitol building itself. I remember looking out through the taxicab window at the white dome, huge even in the distance. The closer we got, the more my stomach turned. The dome seemed to be standing guard, hovering like a protective parent hugging its child. The three tiers brought to mind past, present, and future. The columns stood strong, erect, and proud. I could feel the honor, strength, and power represented in these structures. Then the familiar fear returned and my gloved hands tightened on the folder containing the speech I’d written.

  People milled about as if it were any other day on the hill. But I knew better. Something big was happening, for me at least. The historic building drew closer and I thought of my dad, who loved this country so much. What would he think if he knew what I was about to do? Would I have the courage the founding fathers had when they risked it all to create this country? Or would I panic? I knew there was no turning back. I was going to tell the world my story in a few minutes, so why be scared?

  I braced for the task ahead. Instead of rehearsing my speech, as I normally would, I imagined my father’s wide smile, crooked teeth, and searching eyes. I realized I still wanted to please him and hear his words of encouragement. I gripped the pages tighter as if the folder itself could bring me peace and calm my nerves.

  My anxiety filled the taxicab; my heart beat faster. I wasn’t afraid of the television cameras. Although I still find them intimidating, my hesitation came from taking another step away from the “nice girl” image, the one that kept me quiet, prevented me from asking questions, compelled me to keep secrets and—most of all—ensured that I project the illusion that I was perfect.

  Would I be a laughingstock? Would they believe me? Would I be a poster girl and lose my privacy, if not my dignity, forever? What did Mary Beth McDonough have to say that might make a difference? Oh, the doubts.

  The familiar warmth of tears filled my eyes and the Capitol, now a blur, beckoned to me. Sybil asked if I was okay.

  I said, “I was just wondering what my dad would think if he could see through my eyes right now, if he would be proud of me.” Here I was, in my thirties and still wanting his advice and approval. My dad had been gone a long time; but he was still so close to my heart, I wished he were there to hold my hand, to tell me I could
do this. Fortunately, I had the next best thing. Sybil squeezed my hand and we stepped out of the cab and headed into the building.

  Walking through the historic foyer, I thought of others who had come before me. I passed marble statues lining the hallways that I imagined whispered words of encouragement. I climbed the marble stairs, worn from thousands and thousands of footsteps like mine, all working toward change.

  Senator Barbara Boxer was holding the press conference, and Sybil, Jenny Jones, and I were giving our personal stories of our breast implants. The first time I addressed the press, I had presented data on the companies. This time, it was personal; this was me telling my story, my secrets.

  With each echoing step, all my emotions mounted. As the chamber doors opened, I saw Senator Boxer smiling at me, and the rows of cameras and lights. The podium was once again stacked with microphones, and all I could think was: How did I get here? All I wanted to do was act!

  I managed to make it through that day. Senator Boxer’s press conference raised awareness and we continued to get the message out, even as women continued to get sick. My next lesson would be an even bigger challenge as we fought against the machine.

  MISFILED AT THE FDA

  In March 2000, the FDA called an advisory panel to approve the PMA (premarket approval application) for saline implants. Advisory panels were made up of plastic surgeons, oncologists, epidemiologists, and other specialists, as well as representatives from industry and consumer groups. They listened to the data to advise the FDA. The ultimate decision was left to the FDA.

  This was my first experience testifying before the FDA. I still felt like a hick who knew nothing about Washington, idealistic enough to believe the doctors on the panel would actually listen to the women testifying, weigh all the evidence, and make an educated decision for their safety and well-being.

  Boy, was I wrong. This was politics. This was big business, and the plastic surgeons and manufacturers stood to make a lot of money. They both put a lot into the pot.

  The first day of the hearings, before any testimony was even heard, the doctors and the panel took a vote to approve saline implants. How can that be? I wondered. No data had even been reviewed. The women’s voices had not been heard yet.

  I entered the hotel in Gaithersburg, Maryland, and the women were already upset. One woman looked at me and said, “Well, we lost this one. The panel isn’t listening. They’re done.” It felt wrong and unfair, but I would give my testimony, anyway.

  It was very intimidating. I was not an expert, just a woman giving her story. I held the pages of notes for my testimony and walked into the crowded room, with rows of chairs, and sat down.

  The panel sat behind tables at the front of the room. There was a podium for speakers, and red and green lights to monitor time. I listened as the speakers ahead of me went on and on, most of them going longer than their allotted time, ignoring the red light indicating their time was up. I heard specialists speaking the praises of saline implants and what a necessary product they were, how the scientific research supported their safety, and there was no reason not to uphold their recent approval.

  My mouth got drier as each speaker finished, moving me closer to the podium. I studied my pages as my mind raced and hands shook. Finally it was my turn.

  As I walked forward, my tongue stuck to the roof of my mouth; and my knees shook so much, I thought I would faint. I gripped the podium to steady myself and faced the bored-looking panel. The green light came on and I thanked them for allowing me to testify. I spoke fast, so I could get my message out. I had a lot to say in a short amount of time.

  I challenged the safety of the implants, specifically how they could trust the data presented when they didn’t have all of it, because—and here’s the unbelievable part—when women called the FDA to report problems or “adverse effects” with their implants, these reports just happened to be filed under a number listed for Waterpiks! This was the first of many unbelievable revelations disclosed during the many FDA hearings I attended.

  As I spoke, I watched the faces of the panel members. They showed no concern; something fishy was going on. The green light flashed, warning me my time was almost up, but I had more to say. Since the others had been allowed to go over, I plowed on. The moderator immediately cut me off when the light went red.

  “Miss McDonough, your time is up.”

  I kept talking to get it all into the record.

  “Miss McDonough.” He started banging the table.

  Oh, I got it. If I had an opposing view, then I wasn’t allowed to finish. I saw this manipulation over and over again. Sick women were silenced because they ran out of time; while the doctors and paid “scientists” were allowed to speak overtime. I started to feel like I was in the movie The Insider, and implants were the new tobacco.

  One argument from breast cancer survivors was that since silicone implants were so bad, they “needed” saline implants. However, breast cancer survivors were never denied any kind of implant—even when they were restricted for augmentation in 1992. Oddly enough, six years later at the PMA hearings for silicone, I heard the same argument made in defense of silicone implants because saline implants had been found to be awful.

  The panel and experts expressed concern, but to my dismay, recommended approval of saline implants, and the FDA approved them. The panel requested additional research, expressing concern for the high rupture and complication rates, especially for cancer survivors. The data showed 73 percent of mastectomy patients had complications within three years of receiving them. There was concern over the risks because there were no long-term studies. There was testimony regarding the early detection of cancer, because the implants obscured breast tissue in mammograms. Saline implants were found to harbor bacteria, produce mold, and cause infections. However, the panel felt that as long as women knew the risks, they were “reasonably safe and effective.”

  But who was responsible for getting that information out to women? Officially? No one. So we, the sick women, started to educate the public on the risks by sharing our own experiences.

  Since then, we’ve worked to educate women all over the country. I started In the Know as a support group for women in the entertainment industry who had problems with their implants; soon I realized it was for women everywhere. We received e-mails from all over the world. Women were sick, had complications, and needed help. We organized rallies, press conferences, and marches at the FDA and the Health and Human Services building in D.C. At one important rally at the HHS, we carried our signs requesting the FDA examine the approval process, and the FDA itself. There were obvious conflicts of interest within the departments.

  Something I found interesting and conflicting was when Medicare and Medicaid had to cover the expenses of women with illness and damages from implants, they went after the manufacturers to repay the expenses. The government recouped over $20 million from the manufacturers. Now the FDA was poised to approve silicone implants, the very product they had received huge amounts of money for in restitution for payment for women who had become sick with implants.

  If a federal agency, in this case the HHS, takes money for damages from a product, doesn’t it seem odd that another branch of the same agency, the FDA, is able to approve the very product that just cost them millions of dollars—much less the harm that was obviously done as indicated by the amount spent to care for these women? Even Mary Q. Public, who is not great at math, gets it. This just doesn’t add up.

  SECRET AGENT MAN

  At one rally, as we stood in front of the Health and Human Services offices, a man with a camera came out of the building. He stood yards away from us and, not so covertly, zoomed in on each of us.

  Someone said, “Well, we all have our own file now, girls. Watch your step.” I couldn’t help but feel there was something covert going on and thought of my “clicking” phone. When someone approached the guy with the camera, he would not answer any questions and went back inside. The mystery of activism continue
d.

  SENATORS

  Now this is a cool part of the story. As you know, I am in awe of public figures I admire. Here I was in Washington, D.C., in my thirties, learning how to be a citizen activist and meeting with congressional members about our cause. To me, that was incredible in itself. Senator Barbara Boxer was an early champion for women on the implant issue. We appreciated her help and understanding at a time when we were being painted in the press as, yes…crazy. I loved meeting her and having our picture taken. It was so cool. This issue has gone on so long, I have a more recent picture of me with her. I’m older and a bit more haggard. But she’s wonderful and still working alongside us.

  One of my favorite moments happened at a party at Senator Edward and Vicki Kennedy’s home. I felt so lucky to be invited, I was beside myself. Vicki Kennedy is a woman of such poise and elegance, you forget you have just met her. She made me feel comfortable in an instant. She’s so smart and has the best smile. I could gush on and on.

  Oh, and her husband? Only an icon. What he accomplished for this country in education and health care alone was amazing to me. It was an honor to be in their home and meet them. I couldn’t help but think of what my dad and mom would say if they knew where I was, if they could change places with me for one second. Now, my dad was a pretty calm guy, but I think he would have had butterflies, too. I looked around the house, petted the dogs, and begged someone to take our picture. I have proudly displayed that picture in my home ever since.

  Then the most amazing and unusual thing happened. We were talking about being Irish, my hair, the freckles, etc., and the senator started singing Irish songs…to me! Okay, there were other people there, too, but think about it. I’m in the house, the famous-family photos are everywhere, and I was being serenaded by Senator Kennedy. One of the best stories I have, so put the book down now. Just kidding. Senator Kennedy’s office has also assisted us for years on this issue. It was so nice to be actually heard.