Trials of silicone breast implants raise concerns

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You won't have to "join" to read this . . .Ilena Rose <ilena.rose@...> wrote: Thanks Rogene! http://www.nj.com/printer/printer.ssf?/base/news-8/11554444054100.xml & coll=1 Trials of silicone breast implants raise concernsEssex surgeon warned on protocol Sunday, August 13, 2006BY ROBERT COHENSTAR-LEDGER WASHINGTON BUREAU WASHINGTON -- Lori Apgar faced the nightmare of breast cancer lastyear.

She underwent a double mastectomy, then turned to plasticsurgeon Spiro of West Orange for breast reconstruction using silicone gel implants. "He is the one who made me feel there was hope and who put me backtogether," said the 48-year old Long Valley resident. "I woulddescribe him as an unbelievable, caring and considerate doctor who leaves no stone unturned. He was there for me." Apgar received the silicone implants -- which have been the subject ofa raging controversy for almost two decades and are not still notapproved by the Food and Drug Administration -- through a government-sanctioned clinical trial designed in part to gather dataabout medical complications women may experience after breastreconstruction. But

in a lengthy warning letter made public last month, the FDA saidSpiro failed to strictly follow the study protocol -- rules designedto protect patients and ensure the data collected is scientifically reliable. The FDA said Spiro did not report all medical complications; hadinaccurate and incomplete medical records for some patients; did notreturn for inspection implants that were surgically removed; and used an unapproved version of the informed consent form. The case of the New Jersey surgeon highlights concerns expressed foryears by women's health advocates and consumer groups about misstepsand problems associated with clinical studies of silicone breast implants. "This is not a question of the doctor's skills but about

theimportance of collecting the data on patient outcomes both in theshort term and long term in a rigorous fashion so we will have better information on the safety, effectiveness and complications of thesestill experimental devices," said Wood, a former assistant FDAcommissioner for women's health. "Unfortunately it appears that these studies are not being carried outproperly and it is women who suffer in the long run," Wood said. While the FDA called the violations "serious," Spiro, described bycolleagues as a meticulous surgeon, said the findings had "nothing todo with the implants or the medical outcomes." "It's all about dotting all the i's and crossing all t's. How manynit-picky inconsequential things could they

find? It's very unfair,unfounded and unjust," Spiro said. "They came in here looking for something negative, and the only things they could find were clericalthings and that is sad." Spiro faulted Mentor Corp. the implant maker and study sponsor, for"letting me down" by not providing the proper support regarding thereporting requirements, and said there were disputes between the company and the FDA on interpreting the protocol. A Mentor spokesman would not comment on Spiro or even confirm that hewas part of their clinical trial known as the Adjunct Study. But acompany statement said "Mentor has been very proactive in our approach to working with and supporting physicians," and has "an entire staffdedicated to the Adjunct Study." CONCERNS PROMPTED BAN Silicone gel implants went on the market in the early 1960s, beforethe FDA had authority to approve medical devices for safety andeffectiveness. In 1992, the silicone implants were banned amid concerns about health problems caused by ruptures and leakage offluids into the body, and an FDA conclusion that manufacturers couldnot prove they were safe. Saline-filled implants, considered less natural in appearance and feelto silicone, have remained on the market and are widely used forcosmetic purposes. While women testified last year before an FDA advisory panel aboutserious health problems stemming from silicone implants, includingconnective-tissue and autoimmune diseases, medical research to

date has not verified these claims. Despite the 14-year ban, thousands of women have received siliconeimplants through FDA-approved clinical trials like the one involvingSpiro. The studies have included breast cancer patients needing reconstruction after mastectomy, women with congenital deformities andthose who have had trouble with saline or older silicone implants. Spiro was part of Mentor's national Adjunct Study, which has included70,000 women since 1992. The data from the Adjunct Study has been used to supplement a smaller,separate clinical trial involving 1,000 women that was submitted tothe FDA in 2005 as the basis for seeking approval to market its silicone implants. Mentor was faulted by members of an FDA advisory panel and healthgroups last year for losing track of patients enrolled between 1992and 2002 in its Adjunct Study, with the company able to follow up on only about 19 percent of the women three years after surgery, andabout 11 percent at five years. STUDY'S DATA CRITICIZED Amy Newburger, a New York dermatologist who sat on the FDA's expertadvisory panel that reviewed Mentor's silicone breast implantapplication in April 2005, said the company's Adjunct Study data was "sloppy." "We panelists were very disappointed and dismayed by that," saidNewburger, who voted against approving the implants. Mentor said it has "confidence in the body of scientific informationpresented to the FDA panel about the safety and efficacy" of itssilicone gel implants. Mentor's competitor, Inamed Corp., had the same types of problems witha similar long-running study, and like Mentor submitted data from aseparate 1,000-woman clinical trial as the basis for seeking FDA approval. In July and September of last year, the FDA first told Mentor and thenInamed (now part of Allergan Inc.) that it would let them beginselling silicone implants once the companies met certain medical and marketing safeguards that have not been publicly disclosed. The FDAhas yet to grant final marketing approval to either California-basedcompany. Mentor has continued to enroll patients in its Adjunct Study andcollect data at sites throughout the country. In the warning letter, the FDA said an inspection of Spiro's clinicalsite in March and April found that five of 56 women patients sufferedmedical problems requiring surgical interventions that had not been reported to Mentor or to Saint Barnabas Medical Center's InstitutionalReview Board in Livingston overseeing the clinical trial. The FDA said implants removed in two cases because of complicationswere not returned to the manufacturer for analysis as required; that38 of 56 subjects in the study signed "unapproved versions" of the informed consent forms; and that some medical information regardingthe implant operations and patient case histories was not documentedfor a

number of patients. It found records designed to track the use and disposition of thebreast implants were inaccurate or incomplete, and that three breastimplant operations took place after Spiro's clinical trial certification had expired. Spiro said Mentor told him in several instances he did not have toreturn the removed implants or report adverse reactions because theydid not involve any problem with the product itself. Mentor's statement said the study protocol states that "any implantremoved as a result of an adverse event must be returned to thecompany." VIOLATIONS WERE 'MINOR' Spiro

said inventory control was not part of his responsibility, andthat his patients, despite the paperwork citations, were all fullyinformed at great length about all their rights and the risks. The West Orange doctor said he received permission from Goodman, a radiation oncologist and head of the St. BarnabasInstitutional Review Board, to conduct the three operations after his clinical trial certification lapsed. Goodman confirmed he made an exception to allow the three surgeriesbecause the review board did not have a scheduled meeting, and he saidSpiro's certification was later renewed. But the FDA said this still represented a violation of study protocol. Goodman said Spiro had a responsibility to "report all data in

atimely fashion on every correct form" and to ensure the informationwas accurate and reliable. But he said there is no FDA claim of harm to any patients, and thatlooking at the bigger picture, the violations are "minor" even thoughthere is a need to "follow the rules all of the time." " is an extraordinarily compassionate plastic surgeon," saidGoodman. Wood, the former FDA head of women's health, said Spiro hadobligations to his patients and as a clinical researcher. "Theinformation is no good if we don't have quality studies. It is critical that doctors who engage in this research are held accountablealong with the medical review boards and the companies," she said. ~~~~~~~~~ www.BreastImplantAwareness.org