Lessons from the Mountain

by Mary McDonough

  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 expert
s. 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.