Fw: Back from vacation, changing e mail addresses, new articles, etc.

[Guest guest]

From our good friend Zuckerman, in Washington DC

----- Original Message ----- From: CPR4WandF@...

Sent: Saturday, August 25, 2001 10:31 PM

Subject: Back from vacation, changing e mail addresses, new articles, etc.

Dear Friends, I came back from vacation a few days ago and am still trying to catch up with: 1. New FDA guidance re studies on breast implants. Unfortunately, the requirement for approval is listed as a 2-year study, which we all know is not long enough to provide useful information. I will be back in touch as soon as I learn more about this document. 2. Ads in teen magazines for "natural" breast enhancement products. Magazines aimed at girls 10-18 are running full-page ads for creams and pills that are "guaranteed" to increase breast size. Since there is no evidence that these products work, we need to be concerned about the message that these ads are sending to very young girls and self-conscious teens. We also need to be concerned about possible risks. If any of you have any information about these products, please let us know at dz@.... 3. And yes, I am changing my e mail address to dz@.... 4. In a lengthy Q & A article with sexuality questions, Glamour magazine minimized the problems caused by breast implants regarding loss of nipple sensation and ability to breast feed. (They did warn women to discontinue breast feeding if a woman has a ruptured implant or other problems). Here is my letter to the editor, and I encourage those of you with personal experiences to also share them with Glamour. To the Editor of Glamour (letters@...): Glamour has provided excellent information about the risks of breast implants in the past, but the August issue included misinformation in response to a readers question: "If I get breast implants, will they reduce my nipple sensitivity? Will I still be able to breast-feed?" Your experts, Drs. and Berman of the Female Sexual Medicine Center at UCLA, indicated that most women would not have these problems. However, they failed to mention that many women with implants do have these problems, and are very upset about them. Mentor and McGhan, the manufacturers of most of the breast implants sold in the U.S., reported to the FDA that within the first three years approximately one in seven augmentation patients complained of nipple changes (usually loss of sensation but sometimes excessive sensation) and approximately one in every four or five augmentation patients complained of breast pain or hardness. Although doctors tell their patients that nipple sensation will return to normal, many women find that the damage is permanent. So, while the doctors are correct that "most" women do not lose nipple sensation for more than a few months, many women with implants have loss of nipple sensation, pain, or hardness. In addition, the Institute of Medicine has reported that all breast surgeries, including breast implants, triple the likelihood that a woman will not have enough milk to breastfeed her baby. So, this is also a real risk that women should be aware of. Sincerely, Zuckerman, Ph.D. ----- And below you will find some new articles published in an Ohio newspaper. Some of you may want to thank the author for her efforts -- a five part series! Her email address is below. Best wishes, www.center4policy.org www.breastimplantinfo.org From The Courier, Findlay, Ohio, 8/25/01

Saline implants not fool-proof

EDITOR'S NOTE -- This is the fourth installment in a five-part series exploring the controversy surrounding breast reconstruction surgeries. Names of those who spoke about their surgeries have been changed at the women's request. By LAURA TUCKER FAMILY EDITOR No surgery is foolproof, according to an area plastic surgeon, who, like the women interviewed for this series themselves, asked not to be identified. There are risks involved in even the most simple procedures. When it comes to breast reconstruction surgery, it seems the skin flap procedures are the most complicated and have multiple risks. However, the same degree of risk goes for implants. Silicone gel had more of the consistency of breast tissue and saline implants were more like water bags, the doctor said. But problems with silicone gel implants have led to the popularity of saline implants. The doctor said he hasn't used silicone gel implants in nine years. He said that if silicone gel leaks, the substance may stay within the pocket created for the implant. If saline leaks, it is more likely to spread throughout other areas, making it easier to visibly detect that a leak has occurred. But if leaking silicone gel migrates to other parts of the body, it can cause severe health problems. Some of the problems associated with silicone gel implants, however, are related to simply having a foreign object in one's body. And those problems are also possibilities with saline implants, the doctor said. He said that, to his knowledge, the body will not cause an implant's silicone container to break down into tiny pieces. Silicone is used in the envelope of the saline-filled implants. No studies have been done that conclude the body causes a chemical breakdown of the implant shell. However, silicone is a manmade material and with time can become weak. Many women have complained that their implants became hard. The doctor said those women are actually experiencing hardening of scar tissue around the implant. All women will develop scar tissue. Some of them, no matter what the site of the operation, will develop hard scar tissue. Some won't. The hardening of the scar tissue causes the pocket of the implant to shrink (capsular contracture), thus the implant feels hard. The surgeon said some people have had implants for many years without any problems. Others have problems early on. There is no way of predicting that. There are no tests that can be given prior to the surgery to determine how a person will heal. If scar tissue from any operation of any kind is extensive, the patient will experience pain, the doctor said. "I believe patients should be aware of the risks," he said. "Only a patient can decide if the risks are worth it." The doctor gives potential reconstruction patients a pamphlet describing each available operation -- and outlining the various risks involved. "Breast implants are not considered lifetime devices. You will likely undergo implant removal with or without replacement over the course of your life," the pamphlet warns. The pamphlet, from Mentor Corp., a manufacturer of saline-filled implants, lists risk rates obtained from clinical studies on Mentor breast implants. Reconstruction complications (for saline implants only) included a 40 percent chance of reoperation, a 35 percent chance of loss of nipple sensation and a 28 percent chance of asymmetry. Of the 116 implants removed from reconstruction patients during the study period, 30 were removed because of capsular contracture; 30 because of infection; 25 because of leakage/deflation; 13 because of asymmetry/wrinkling/sagging/scarring; seven for size/style change; six due to necrosis/extrusion; four because of breast pain and one due to breast cancer. The statistics showed 31 percent of reconstruction patients faced reoperation. This pamphlet also advises patients on how to choose a surgeon. It describes the sizes and shapes of implants and subglandular and submuscular placements as well as incision sites. The plastic surgeon said he thinks the pamphlet is very informative. He encourages his patients to gather as much information as they can before making a final decision. However, he said, he cautions them when going to the Internet for information. Information put on the Internet has not been screened for accuracy. "If a person cannot decide to have it (breast reconstruction) or not, they are better off to postpone the decision on reconstruction," the doctor said. The surgery can be done just as well at any later date as when a mastectomy is performed. The bottom line and best advice the plastic surgeon said he gives any patient considering breast reconstruction is: Ask questions! ---------- Phone: (419) 427-8409 lauratucker@... EDITOR'S NOTE -- While they may not have the answers, area legislators are not ignoring the demands of their constituents that breast reconstruction issues be investigated.

Proposed amendment to Cancer Rights Act

, a local woman left disabled after a Tram Flap operation, has proposed the following additions to the Women's Health and Cancer Rights Act of 1998: "Hearings must be held of testimonies of women damaged by breast reconstructions. A moratorium needs to be made on silicone and saline implants, until they can be proven safe for women and the unborn. A ban should be made on all Tram Flap reconstructions due to the crippling results of the operation and the possibility of death for women and unborn children. Finally, strict legal guidelines need to be imposed for other breast reconstructions. "Guidelines for breast reconstructions: "1. Required uniform medical history checklist for any patient considering breast reconstructive surgery, for the purpose of identifying any medical problems, which would disqualify them from surgery, such as bowel and/or back problems. "2. Required patient participation with interactive computer program that details procedures and complications of surgery, and an option to view a videotape of the surgery. "3. Detailed consent form given to the patient three days in advance of surgery that lists complications and warnings of the intended surgery. "4. Accountability of physicians equal to that of other professionals, with consequences of medical license being revoked and criminal prosecution of doctors who disable women or cause the death of an unborn child, due to reconstructive breast surgery."

Legislating ethics?

EDITOR'S NOTE -- This is the fifth installment in a five-part series exploring the controversy surrounding breast reconstruction surgeries. Names of those who spoke about their surgeries have been changed at the women's request. By LAURA TUCKER FAMILY EDITOR The debate rages on -- medical professionals versus patients who suffered botched operations; women pleased with the outcome of their surgeries versus women who insist all breast reconstructions should be disallowed. Is there a right and a wrong? The only plastic surgeon who was willing to address the subject (on the condition of anonymity) said he believes it would be wrong to ban such surgeries based solely upon the experiences of women who were displeased with the outcome of their cases. On the other hand, he said, patients considering breast reconstruction must research what they are considering and ask lots of questions. , whose Tram Flap operation has left her disabled, said she is asking legislators to conduct research on breast reconstruction procedures and the motives of plastic surgeons who perform such operations. (See related story, this page.) She has been instrumental in forming Sisters for Informed Consent, a group working on the state and federal level to make legislators aware of the difficulties women face when considering breast reconstruction, and the results of operations gone wrong. , and others like her, are being heard. Congressman Oxley has co-sponsored H.R. 1961, which was introduced by Rep. Roy Blunt, R-Mo., on May 23. The bill, also known as the Breast Implant Research and Information Act., is to promote research to identify and evaluate the health effects of breast implants; to ensure that women receive accurate information about such implants; and to encourage the Food and Drug Administration to thoroughly review the implant manufacturers' standing with the agency. The bill's findings note that the Institute of Medicine estimated that 1 million to 2 million American women have received breast implants over the last 35 years. From 1985 until January 2000, the FDA received 127,770 adverse reaction reports for silicone gel-filled implants and 65,720 adverse reaction reports for saline-filled implants. Silicone breast implants have never been approved by the FDA, which just approved saline-filled implants in 2000. After three years, 43 percent of breast augmentation patients and 73 percent of reconstruction patients receiving implants experienced complications. "It is the purpose of this Act to promote research to identify and evaluate the health effects of breast implants, to ensure that women receive accurate information about such implants and to encourage the Food and Drug Administration to conclude its criminal investigation based on the allegations of wrong-doing by one of the implant manufacturers which ultimately may affect their products and health of American women," the bill states. H.R. 1961, and a similar Senate bill S 961 which was introduced in the Senate on May 24, have been sent to their respective subcommittees on health issues for study. sent a proposal to Congressman Oxley suggesting additions to the Women's Health and Cancer Rights Act of 1998. Recently, received this reply from Congressman Oxley: "I wanted to report back to you on the action that my office has taken on your concerns about tram flap reconstructive breast surgery. Thank you for bringing this matter to my attention. "Your experience with this procedure is highly distressing. I have great sympathy for the pain that you have suffered, and appreciate how motivated you must be to prevent other women from sharing a similar ordeal. I commend you for your activism. "You sent me a voluminous amount of information on the tram flap procedure and on your particular case, which I appreciate. No person should have to undergo what you have endured. "As you know, I have cosponsored H.R. 1961, the Breast Implant Research and Information Act. The focus of this bill is on silicone and saline implants, which have been the subjects of considerable medical and media attention. Since the bill targets implants, which are devices foreign to the body, rather than tissue replacement, it does not speak to other types of breast reconstruction surgery. However, I am contacting the sponsor of the bill, Rep. Roy Blunt (R-MO) to let him know of your interest in broadening the scope of the review that would be conducted by the National Institutes of Health. "I have seriously reviewed your proposal to amend Public Law 105-277, the Women's Health and Cancer Rights Act of 1998, to mandate more extensive consultation between physicians and candidates for the tram flap procedure. For an assessment on the prospects of enacting such legislation, I consulted with the House Committee on Energy and Commerce, whose Subcommittee on Health would consider amendments to the law. "I noted that you feel you were not adequately informed of potential complications from the surgery, and are thus proposing a legislative remedy that would require a thorough background check of patients, patient viewing of a video detailing the procedure, and the signing of an explicit consent form prior to surgery. "Many of your proposals strike me as making good medical sense. To provide the best service to their patients, physicians should be doing many of these things already. However, after its own review, the Committee has advised me that there may be more effective and immediate remedies than a change in the law. While your belief in the need for full disclosure to patients is widely shared, Congress has historically been reluctant to legislate in an (sic) the area of personal physician-patient communications. Legislative language could create a new set of unknown liabilities with unintended consequences, such as a physician claiming as a result of a consent form a patient has 'signed away' his or her right to sue for malpractice. While the Food and Drug Administration (FDA) establishes guidelines affecting medical devices, the federal government has hesitated to bar particular surgical procedures. An operation that may be risky for one patient may be of comfort and benefit to another. Disputes arising from medical decisions have historically been addressed by ethical standards established by the American Medical Association, disciplinary actions taken by state medical boards, and ultimately the judicial system. "I do believe that your case should serve as a clear warning signal to physician societies and medical boards that doctors, in some cases, may not be adequately informing patients about the potential risks of specific surgeries. Therefore, I am writing to the American Medical Association to bring to its attention the importance and ethical imperative of full and frank communication between physicians and patients prior to surgery. I am also contacting State Representative Mike Gilb, who I understand you have spoken with, about the oversight exercised by the State of Ohio Medical Board. Finally, I will make sure that the appropriate congressional committees and federal agencies remain sensitized to this issue. "Thank you for contacting me regarding this matter, and I look forward to remaining in touch with you. Again, I commend you for showing such concern about the health of women who may be contemplating this procedure. "Yours truly, G. Oxley, M.C., Fourth Ohio District" has pledged to continue her campaign for recognition and research into the safety of breast reconstruction surgeries. She has set up an Internet discussion group, Sisters for Informed Choice, at SIC42001 --------- Phone: (419) 427-8409 lauratucker@...