The more I found out about the dangers of implants from court documents that cited the manufacturer’s own data, the more concerned I became. Dow Corning was found civilly liable for failing to disclose to recipients the dangers of their implants. The company’s own scientists had raised concerns about suspected problems; yet their PR machine continued to argue against women who questioned the connection between implants and health concerns.
Internal documents indicated that complications reported by women had been suppressed. I found out there had been suspicious links to autoimmune diseases, and an entire community of researchers disagreed on the safety of silicone use for medical purposes for several years before I even had implants. Why hadn’t my doctor told me any of this information? Terror ripped through my heart. Had I poisoned myself and my baby girl? What had I done by having implants?
The court transcript exhibits included one study I’ll never forget. In 1967, Dow Corning commissioned a four-dog twenty-four-month study using miniature silicone implants. They implanted dogs with samples of the devices—like the ones used in women—and examined the subjects at six months, and then at twenty-four months. Well, three of them, anyhow—one of them had died after only eleven months. The necropsy showed it had liver and kidney congestion, and fibrous tissue reactions at the site of the implantation. The other three were killed at the twenty-four-month end to the study. All of them had severe or moderate inflammation at their implantation sites.
This is a small sample in the world of scientific research, and probably wouldn’t have received a lot of attention; except that in 1973, Silas Braley, of Dow Corning, published a report of the study. He falsely claimed that there were no differences between the six-month and two-year results on these poor dogs. They supposedly found no adverse reactions upon necropsy, and he also failed to report that one of the dogs had died during the study.
First, I thought about the cruelty to the dogs. Imagining breast implants in a dog still makes me shake and outrages me.
Second, as a consumer, I had been kept in the dark about the company’s own studies and research because confidentiality orders in litigation often impede the information from reaching the public. It’s protected until a trial. If someone settles out of court, important details may never reach the people who most need to know the information. Unless someone knows to look for the court documents—and knows there is anything to look for—the information doesn’t get out.
The other red flag is that if Dow Corning’s own scientists had published studies with inaccurate and misleading conclusions, how many other discrepancies and poorly constructed research was being presented as worthy and was putting women at risk?
When women started to get sick, they didn’t look for court documents, thinking it was their implants. When I had my symptoms, I didn’t think of calling a lawyer. I went to the doctor to get well. So, for years, no one looked for this information. There was no “link” back then, and my plastic surgeon certainly wasn’t talking, either.
In 1977, a woman from Cleveland sued Dow Corning because her implants had ruptured and caused her a great deal of pain. Richard Mithoff, a Houston attorney, argued successfully for her case and she accepted a settlement. This case didn’t receive much publicity at the time, but the internal documents, lack of scientific research, and compelling argument against a medical device that causes harm was the boulder we women have pushed uphill against the manufacturers, plastic surgeons, and, in some cases, the media ever since.
As silicone implants became more widely accepted and accessible, the detriments to women increased, but apparently corresponding research and long-term studies on their safety didn’t keep up. As I read further about the history of the industry, I found out more cases of harm done to women like me.
In 1984, a jury had awarded Maria Stern, who had immunological problems caused by her silicone implants, $211,000 in compensatory damages and $1.5 million in punitive damages to be paid by the maker: Dow Corning.
BUT I PLAY ONE ON TV
I started to work a bit more as I got better and was lucky enough to get the role of a lupus patient on ER. After filming, the Warner Brothers publicist called me and said he’d heard a rumor I actually had lupus, was it true? I said yes. He asked if he could release it to the press. It was a huge decision I agonized over. I was getting better and I was working again. Did I want to admit to being sick? In public? Would the industry judge me as a risk, unable to work? Who would hire me? Would I lose jobs?
As I learned to do with tough decisions, I meditated. I got quiet and connected with the inner me to find an answer. My thoughts reviewed the letters, the march, faces, and e-mails from the women who had contacted me for help. I thought of my dad and wondered what he would advise. I talked to my mom and she was supportive of anything I decided. She knew how much I wanted to work, but also how important it was to help people. Some of my friends advised against it. “You just started to get your life back—don’t do it. You may ruin your career,” they reminded me.
When I made my final decision, it was because I believe I was given this experience for a reason. I feel my path is to tell my truth, no matter how difficult. I had donated so much of my life to charities I wasn’t personally connected to, now I could actually speak from what I knew. I said yes.
After the ER publicity, a People magazine article followed. Then I got a call from MSNBC to talk about ER on their news show. The broadcast coincided with the release of what we now call the “nuts and sluts” study. The Fred Hutchinson Cancer Research Center reported that women with implants drank more, had more abortions, a greater number of sex partners, and dyed their hair more than other women. So I guess the conclusion was that since we were all trashy women, anyway, it was no wonder we were always getting sick.
Something I had learned in my research of the implant industry was that it’s often difficult to get clean “science” when the manufacturers themselves pay for the results. I know this is a standard practice, but I think it sometimes creates a conflict of interest. This happened over and over with implant research; take for instance the “nuts and sluts” study.
Two of the doctors conducting the study had connections to the manufacturers. The Journal of the American Medical Association, or JAMA, reported that one doctor served as an expert witness defending the epidemiologic methods, which is the research to determine the relevance of silicone implants to women’s illnesses, used in proving the safety of breast implants. The other doctor had been retained as a paid consultant to several law firms representing defendants in breast implant litigation. Hello? Do you see a pattern here?
Sensing possible media trouble, I agreed only to talk about my role on ER; I would not comment on the study.
I was in an L.A. studio the morning of the show; the anchors were in New Jersey. I sat in the news studio and listened to their disembodied voices speaking in my earpiece. I looked into the camera lens and tried to be personal in this disconnected setting. I was prepared to speak about how honored I was to be on such a great show, ER, and to help raise awareness for lupus, a disease I had. That was how I wanted to make a difference.
I wasn’t prepared for what did happen. When we went live, the reporters ambushed me. They challenged me about the study and said things like, “Doesn’t this make your former comments about implants false?” and “What do you have to say now that science has shown women’s lifestyles are a factor in their illness after getting implants?”
They fired one question after another, citing the study, cornering me, challenging me to defend myself and anything I’d ever said about the danger of implants. Luckily, I knew enough about the study to speak to it, but defending myself against these voices in my ear threw me. And besides, I was really interested in speaking about lupus, not the “nuts and sluts” study.
At the end of the interview, I was still connected by microphone to the studios on the East Coast. I addressed by name the guy I had made the agreement with, and sarcastically “thanked” him for setting me up on live television, then threw the microphone on the chair and walked out of the studio.
I shouldn’t have been so trusting or surprised they’d broken their promise. I felt the fool; it was humiliating. I still didn’t manage the media well.
This would be the beginning of years of public scrutiny and criticism I received for standing up for what I knew to be true. I was a healthy girl. I got implants and got sick. I got them out and got better.
My mind swirled with the decision I faced. I could give up, move on with my life, and hope everyone would forget about any of this so I could go back to the business of auditioning for work. Or, I could get a spine and speak up for myself and other women who were being harmed or who would potentially be harmed in the future. What would happen to my career if I continued speaking out, telling my truth?
MY FOUR-LEAF CLOVER
When I got home from that interview, my phone rang. It was a man calling from Washington, D.C., and he told me one of the support group women had given him my number. He told me he was working with the sick women and trying to help them have a voice in the U.S. Congress. I was suspicious.
“I’m working with women who’ve become ill from the implants to give their testimony before Congress and the nation. Here it is, 1996, and we’re still fighting for more testing and help for women who have been harmed. Would you be willing to help us? We could really use you in our efforts. Since you are recognizable, people feel they know you. The connection with you would help reach women and their families on this issue.”
Talk about lousy timing. After that MSNBC interview, I was in a foul mood and told him I didn’t think I ever wanted to speak out on this topic again. I’d never wanted to be a poster girl—I just wanted to work. He said he understood, but his words about the importance in getting the truth out there resonated in me. The reasonable side of me took over and I told him to call me in a few weeks.
His name was Tom Sheridan, and he did call back exactly two weeks later. I didn’t know it then, but this Irishman would become my personal four-leaf clover.
Tom told me about an effort to help educate women and Congress, to challenge the implant manufacturers on what they knew about the dangers of the devices, and how long they’d known their potential to harm healthy women.
“Mary, would you be willing to come to Washington to launch the effort in a press conference?”
Wow! Getting the information out to the public was important, but why was it up to me? Wouldn’t it be easier to hide under a rock and deal with my own troubles? I’d already experienced one public humiliation in that MSNBC interview. Did I really want more public scrutiny, to be vulnerable with something as private and personal as my breasts, my illness? Did I want to focus on what was wrong, instead of what was good and positive? Where was that rock?
My McDonough upbringing that taught me responsibility to others, and my sense of family I’d learned on Walton’s Mountain, kicked in. Too many women had been made to feel insane by their doctors and communities, me being one of them. Women deserved to know the facts I never got to see so they could make educated choices.
“I’ll do it,” I told Tom. “But only if you can promise me that I won’t be ambushed again.” He promised, and to this day—fourteen years later—he has kept his word. While I have faced scrutiny, tough press, difficult testimony, and a PR machine designed to eat innocents alive, I was never blindsided again.
No longer the unprepared little girl, I learned the history of the implant developers and their sophisticated marketing machine. I was armed with facts and the truth. This time, I was prepared for the minefields I danced into.
By agreeing to appear at this press conference, I launched myself into a cause I had prepared for after a lifetime of lessons about honesty and giving back, having a voice, and finding one of my life’s purposes—poster girl, challenges, public criticism, and all.
THE ENEMY LIST
The press conference was at one of the oldest historical establishments in Washington, D.C.—the Old Ebbitt Grill. I didn’t have time to enjoy the ambience and significance of the pub once frequented by Presidents Grant, Cleveland, Harding, and Theodore Roosevelt. I had a speech to deliver and I was nervous. This was bigger than the rally on the street; cameras and microphones were lined up everywhere. People always think because I am an actress, public speaking should be easy. It’s a completely different ball game for me. It’s not like acting at all. It’s you out there, not a character. Besides, I wanted it to be perfect, of course. This was too important to screw up.
There was some commotion at the press conference when the “other side” tried to crash our party. The machine’s “people” came to the grill and tried to get in. I was surprised they even cared. Dow had always denied any wrongdoing, so why did they care about this press conference so much? Made me wonder what they were hiding or what they were afraid we might shine light on. I found out they had hired a $10,000-a-day PR firm to defend them. This was fascinating and a bit scary to me. I was just Jane Q.—or now Mary Q.—Public here to tell my story, but the real story only got bigger and more aggressive.
One of the stories could have been generated in a Hollywood script mill, for all its irony. John Swanson had worked for Dow Corning since 1966. In 1976, he had been assigned the task of forming their Business Conduct Committee, designed to prevent unethical activities by Dow employees and its representatives. John was at the conference, and as I learned his backstory, the ironies and bravery of this man astounded me.
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 continued.
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.
I also have another photo of Senator Kennedy and me taken a few years later. I always wanted him to sign it, but I felt like the girl with the orange corduroy book. Then the senator was diagnosed with cancer, so I was even more hesitant. Tom Sheridan told me to send it to his office. I did, and just before he died, I received the photo signed To Erin, Ted Kennedy. I was amazed he even signed it, let alone to my alter ego. Tom told me that was his Irish humor. I cried for a week when he passed, all the time praying for and admiring how brave and beautiful Vicki was as she mourned his passing.
Having met with his office so many times over the years, now knowing I never would again, I felt an end had come for our country, my activism, and being a voice for the “little guy.” How would we climb the mountain without Senator Kennedy championing the way? Something great was gone. Not just an era, but for me, my life had come full circle at the loss of the senator. It felt tied to my father and my roots. I am grateful for all his work, especially because my own daughter was helped by him shaping the Americans with Disabilities Act. I will always remember his smile, singing “When Irish Eyes Are Smiling” with that twinkle in his own.
Senator Dianne Feinstein, another of my senators from California, was also good to meet. We were invited to her constituent breakfast, and we shared our concerns on breast implants. Having two female senators is an accomplishment. Having them both listen is even better.
I have met with many members who didn’t care a bit about us, or our issue. There was one senator we were excited to meet because he was a medical doctor. We thought he would understand and be interested, but he didn’t hear our story. We were ushered in for a photo with him and ushered out when we tried to tell him why we were there. A month later, I received the photo and his calendar in the mail. Welcome to the world of politics. I wondered again what my dad would have thought—this place he held in such high esteem, a place he taught me made a difference. He believed in Mr. Smith going to Washington, but what about his little Mary?
Meeting Senator Hillary Clinton was another perk. Usually when we had congressional interviews, we met with the staff and they relayed the information to the member, but Senator Clinton was gracious and met with me herself. Someone you see so often in the news can be overwhelming to meet. I shouldn’t have been timid, because she was incredibly smart, nice, and knowledgeable about lupus and women’s issues. I have to say, of all the senators and congressional members I have worked with in the last thirteen years, there have only been two who knew why I was there before they came into the room. Senator Clinton was one of them. She knew the issue and was willing to help.
After my meeting, I watched her take pictures in the hallway with all the interns (mostly Republican) on their last day on the Hill at the end of their service. They clamored for a chance to get a picture with her. She was gracious and easygoing, and I understood them wanting a picture with her. I did, too. Unfortunately, I didn’t have my camera with me that day, but she did sign her book for me and I treasure it.
CONSERVATIVE TALK
In organizing rallies and speeches, I put myself out there for public awareness. One speech attracted the opposing PR firm and the manufacturers’ lobbyists. I pointed them out in the crowd and invited them to come up and give their side of the story. After all, this is America, and fair is fair. The PR reps didn’t budge, so I picked up the microphone, stepped away from the podium, and went to them. I could tell at least one of them was really nervous I’d pointed them out. They refused to speak and said they were just there to “listen.” Or to spy? Mary Q. gets a clue.
One rally found us working with NOW, the National Organization for Women. We were not against implants; we just wanted women to know what they might be up against. We believed women should have all the information that wasn’t available when we made the decision to have implants.
When I started this fight, the companies were still saying the implants lasted a lifetime; now, at least, they admit they rupture and need to be replaced every seven to nine years. That’s a lot of surgery and expense over a lifetime. Women also need to know the information we obtained from the silicone panel: Implants compromise mammograms, possibly hiding malignancies or other abnormalities. Extra angles need to be shot, or other procedures done, such as MRIs and ultrasounds, taken for more complete coverage. Those tests and extra angles may not be covered by health care plans—further compromising a woman’s health even if the implants remain intact. I’ve known many women who have lost their medical coverage because they had implants.
My daughter, Sydnee, joined me lobbying and at rallies. We had made our own signs, and I think the one Sydnee made stood out with a particularly poignant message: MY MOMMY WAS HURT. I was so proud of her. As I spoke, I said my wish was that she would love the body God gave her and not make the same mistakes I had made due to my insecurities and body image issues. Well, the part about Sydnee loving the body God gave her was quoted in the New York Times and across the country.
I started to get voice mail messages about a certain conservative talk-radio host who was slamming me on the air. I was encouraged to call in, but I was in D.C. I had no idea what was going on. Turns out he saw the photo, my quote, and the NOW signs, and he figured I was a representative for NOW, which I was not. He was not a big fan of NOW and decided to air his feelings. His tirade on this “Mary McDonough person” lasted a few days on air.
He hinted “this Mary McDonough” person might be a NOW radical and wondered if “this Mary McDonough” wanted to deny deaf children cochlear implants because that’s how God made them. One caller even agreed that “this Mary McDonough” probably wanted to kill babies God made, and wondered if “this Mary McDonough” had had any abortions. I was appalled when I heard the tape. All this flack because I wanted women to know the facts before they made an important decision?
Now, that was a huge lesson for me. Still, to have someone tell lies about me and hear angry listeners call in and say horrible things against me was unsettling. I mean, I appeared on The O’Reilly Factor, and even he was more fair and balanced. I loathe how these “shows”—and they are just that—boost their ratings, use misinformation, ignorance, and fear to spur the public into hatred. Mr. Talk Show Host had no idea what the rally was about. He saw a sign, then took a half quote and tried to incite rage in people for his own benefit. What’s more sad is that people buy into these shows; they believe what they hear without thinking for themselves and doing their own research.
TOXIC SUBSTANCES
Silicone was still not approved and the manufacturers worked hard to get approval. In 2003, the FDA held hearings in Gaithersburg to examine the data. Two companies had presented PMAs and vied for approval, Inamed and Mentor. There were no long-term studies presented. Many testified on both sides. We asked—no, begged—the FDA to look at the long-term risks in considering the safety.
Then a funny thing happened. Dr. Edward Melmed, a plastic surgeon who had put implants in women until he saw the damage they were doing, came to the hearings to illustrate how harmful a ruptured implant can be. He had seen firsthand the leaking, rupturing, and capsular contracture. With gloved hands, he reached into a container and lifted out an implant he had removed from a woman to show the panel. Right away, two “security” types approached him and there was uproar. He was accused of bringing “toxic” materials into the room.
He said, “It’s just an implant, the exact material you’re talking about here today.” He was physically removed from the room amongst the chaos.
There have been so many wild, incredible, unbelievable experiences with implants, I can’t describe them all. A few, like this one, stand out. Some of them rocked my Mary Q. sensibilities, and almost all of them pushed my “justice” button.
Over the years, the goal was to get silicone gel implants approved. The surgeons and manufacturers were lobbying hard. I saw big business at work. The 2005 FDA hearings were a bitter disappointment for the women in many ways. Both sides brought out their experts. A New York Times article reported: The American Society of Plastic Surgeons offered extraordinary support throughout the hearing to the manufacturers. Dr Scott Spear, president of the society, is an Inamed consultant and delivered much of its presentation. This showed me how much they had to gain.
Women gave speeches on the value of implants, and others told their sad stories of illness and losing everything—including a girl who had lost her mother.
It was explosive in energy. These are a few of the odd goings-on, to me at least.
The hotel was a hostile battleground of those speaking for and against approval. At times, it was like a war. No one spoke in elevators for fear the “enemy” was listening. There were standoffs in the press and in testimony, and plenty of evil glares to go around.
Women were against women. Doctors and scientists were challenged by each other and the media. I felt so much pressure and stress I had a flare-up and could barely walk. The women stuck together, and our goal was simply to testify with our experiences, which we did.
SILICONE SAILS THROUGH
The FDA’s own scientists testified there wasn’t enough long-term data and research to prove safety. There were still the concerns of what exactly happens when an implant ruptures, where the silicone goes, and what it does when it gets there. There was a ten-year study, but only a few years’ worth of data was presented by one of the manufacturers to prove safety rates. Suspicious, isn’t it? This from a medical device in existence for over thirty years? So why after three decades can’t the manufacturers produce more than three years of data?
A few independent studies, such as one at Tulane University in the late 1990s, showed definite links to autoimmune disease. Dr. Robert Garry, professor of microbiology and immunology, supervised a blind study of 153 women, 110 of them with implants. The results showed the statistically significant presence of an antipolymer, which is an antibody produced to fight off the effects of leaking implants. Dr. Garry said at the time, “What we provided was the first objective evidence that it (a disease resulting from silicone exposure) exists.” What we needed was more information like this, as the silicone was used in many medical devices besides breast implants.
Why did the panel disregard the FDA’s own scientists? Why was a doctor who took money from one of the companies that was seeking approval at this very hearing allowed to stay on the panel? Can you say “conflict of interest”? There were so many questions that the panel never answered.
TOUGH LUCK
As the vote was taken, each panel member spoke. As the New York Times reported: Dr. Barbara Manno, a panel member and professor of psychiatry at Louisiana State University, said the panel wanted to give women a choice of implants.
“And it isn’t to have a choice,” Dr. Manno said. “It is to make a choice. And tough luck if it doesn’t work out.”
This statement brought a loud gasp from the audience. I couldn’t believe my ears. Tough luck? After all this time and testimony, approval came with tough luck? Well, I can speak from over twenty years of implant experience: It has been tough luck for me and many women and their families who have been affected by these devices. Yep, Dr. Manno…tough luck, indeed.
“REASONABLY SAFE”
During previous approval hearings, the FDA was asked if they had any jurisdiction or power to enforce follow-up studies the panel might suggest or require after the approval of a product, they said no. At the end of the silicone hearings, the panel requested more information and market studies for safety. They recommended more long-term data, the study of silicone and its migration. Then the FDA made an unprecedented move. They placed a set of caveats for the implant makers to follow after approval. Since the FDA had no power to enforce or follow up if their own requirements were not completed, these studies still have not been completed.
Since then, both Inamed and Mentor have received approval letters from the FDA and are free to supply silicone and saline implants. The last time I was at the FDA, they were having a difficult time getting the manufacturers to comply with follow-up studies and numbers. They asked us to help them educate women about the studies and encouraged us to “keep up the good work” with the women. This was a depressing and disappointing day for us. We had tried for years to help women get the information, but now Mary Q. felt she had lost the fight. I felt I was a little guy, and big business had won over so many women who were sick, tired, and even made homeless from mounting medical bills.
THE WOMEN
I have met so many powerful women on this journey. Their strength, wisdom, and courage inspired and helped me keep up the fight when it felt like a losing battle. When the world calls you money-grubbing, clucking hens instead of seeing how sick, tired, and beaten-down you really are, it bonds you to each other. That is what happened to us.
One of our proudest moments was to be a part of the legislation to educate about the dangers of implants and improve research for medical devices. Senator Boxer dropped her sponsorship of the Breast Implant and Information Act Bill, so I put my filmmaking experience to use and made videos to educate Congress. Several women, among them actresses brave enough to speak openly in public about their implant experiences, told their stories. Sally Kirkland, Leigh Taylor-Young, Linda Blair, Judy Norton, and Mariel Hemingway were instrumental in bringing awareness to our struggle.
MARIEL
Mariel Hemingway had been so outspoken on the issue, it was great to meet her finally. She agreed to let me interview her. She shared with me how much she liked The Waltons growing up. I was gob-smacked, of course. All I could think of was how I admired her when I was a kid and how great she was in Lipstick and her other movies. I told her how I was impressed with her courage to come forward with her story. She made such a difference for me in the implant experience, and it was an honor to interview her for the video.
SALLY
The colorful, dynamic Sally Kirkland made all the troubles worth the while when she told me I had saved her life by going public about my implant disaster. She had seen my Entertainment Tonight piece and started to wonder if her own implants were what had made her so ill. She became one of the few women in Hollywood who admitted to her experience with implants. She had suffered constant arthritic pain in her neck, back, chest, arms, and legs; inflammation; inability to sleep because of the pain; capsular contractures so severe she described it as feeling like she had a stiff bar running up her neck. She had her last set of implants out in 1998 and continues to speak to women on this issue today. Like me, she began healing and feeling better physically immediately after her explantation.
PAM
I met Pam Noonan Saraceni on a lobby day, and we have been friends ever since. She is a breast cancer survivor, and I mean survivor. She had an implant for reconstruction and developed serious health issues. She had her implant removed and now deals with her life as a survivor, helping and guiding other women. She taught me grace in anger.
She had been working on the issue for a long time when I came on board. One of my first meetings at the FDA was with Pam and other women who had traveled from all over the country to express concern about silicone implants. The head of devices at the FDA took the meeting with us, and it was quite the show. We were nervous, but once we began, it was like a comedy sketch that could have been titled “I Didn’t Want to Meet You, I Still Don’t, but I Will Make an Appearance and Then Have My Staff Give Me a Note, Then I’ll Excuse Myself, Saying I Will Come Back.”
He excused himself and never returned. We were defeated, and felt like this was a big waste of time. This was not the first time we were not heard, but we never gave up. Pam was burning mad and let it be known, in the most classy way, of course. She wasn’t emotional, but direct and to the point. Great lesson.
When I started In the Know, I asked Pam to be my coanchor, and she is to this day.
JUDY
Judy Norton, my own Walton sister, also shared her very personal story about implants in the “Breast Implant and Information” video. Judy is such a private person, it was hard for her, but she is my sister and stood by me. I appreciate her wisdom and vulnerability so much. Her support and strength helped me get the information to so many women needing help. She’s such a great big sister, I was lucky to have her by my side. When In the Know launched with a press conference in Los Angeles, Michael, Jon, Judy, and Kami came out to support me.
There are many more incredible women I have had the honor to picket with and to walk the line with. You know who you are. I am grateful for all your support and encouragement over the years. It was a privilege doing battle with you.
PROSTHESES OUT!
I’ll never forget one of our citizen lobby days on Capitol Hill. Many of us were ill; so it was an especially long day as we walked the halls of Congress.
Many of the women were cancer survivors or had voluntary subcutaneous mastectomies because of family history of cancer. All of us were dealing with the nightmare of faulty implants. We didn’t want to stand out or look like the “crazy hens” the press had painted us to be, so the women who had breast prostheses wore them. Also made of silicone, they are uncomfortable and hot, and worn against the skin, they cause rashes and itching for the women wearing them.
At lunchtime, we were escorted to a room in the basement with our box lunches. Someone said, “I am so glad to be sitting down for a minute to get some relief.”
Another said, “I would have more relief if I didn’t have this stupid prosthesis on.”
They all agreed. Then someone said, “Shut the door.” In the privacy of our little room, she plopped hers out and bounced it onto the table.
The other women looked a bit shocked, but then someone else popped hers out—then another and another, until the table was piled up with fake boobs. They laughed in relief, and the filmmaker in me wished I had a camera. The visual impact of these women with their prostheses strewn in front of them—the very symbols of the battle they’d come to fight—were literally “off their chests.” The image hit me like a train.
I knew I had been allowed a rare glimpse of what these women, who represented countless others, had been through. Laughing and bonding with these women and their common experience was a remarkable moment for me. The impromptu scene that played out in the bowels of our nation’s capital reminded me why my involvement, and indeed all the efforts of these courageous women, was so important.
A few years ago, I was making a toast after one of our marches in D.C. As I looked around the room, I realized that, besides my Walton and McDonough families, these were some of the most resilient, loyal, and generous women and men I ever had the privilege to meet and learn from. I raised my glass, toasted my implants and the whole experience, trying to put into words how these people had changed and touched my life. Talk about making lemonade.