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This year marks the 50th anniversary of silicone breast implants.
But breast augmentation began long before the spring of 1962.
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Substances were injected into women’s chests, researchers say, since at least the late 1800s. They included paraffin, animal fat and industrial silicone.
The 1950s saw all sorts of materials transplanted, even glass balls and sponge implants. the latter shrank, becoming hard as baseballs.
Then, one day in the mid-20th century, after the advent of Playboy, the Barbie doll and high-profile celebrities like Marilyn Monroe (thought to have worn “falsies”) and Jayne Mansfield (considered natural), a plastic surgeon had an “aha” moment.
Dr. Frank Gerow of Houston squeezed a plastic transfusion bag filled with blood and realized if felt a lot like a woman’s breast. in 1961, he and Dr. Thomas Cronin developed the first silicone breast implant in collaboration with the Dow Corning Corp.
Here are highlights of reports since then:
See more in a slideshow here!
1962: Texas factory worker Timmie Jean Lindsey gets the first set of silicone breast implants after doctors propose that she be their first human subject. “I told them I’d rather have my ears fixed than to have new breasts,” the mother of six was quoted as saying. “And they said, well, they’d fix that too. So I said, OK.” Lindsey, now 80, went from a B to a C cup and made history.
1970s: new silicone implants are produced that are more “lifelike,” but they break more easily. Total removal is difficult or impossible. also in this decade, a polyurethane foam covering for implants becomes popular to prevent capsular contracture – capsules of tightly woven collagen fibers created by the immune response to the presence of foreign objects – but the foam begins to disintegrate in the body almost immediately, making it difficult to remove.
1976: the Food and Drug Administration enacts the Medical Devices Amendment to the Federal Food, Drug and Cosmetic Act. the FDA now can approve the safety and effectiveness data of new medical devices. Silicone breast implants, on the market for almost 15 years by then, are “grandfathered” in.
1977: a Houston attorney wins the first lawsuit for a Cleveland woman who claims that her ruptured implants and subsequent operations caused pain and suffering. She gets a $170,000 settlement from Dow Corning.
1980s: Ralph Nader’s Public Citizen Health Research Group warns that silicone breast implants may cause cancer.
1982: the FDA proposes to classify silicone breast implants into a Class III category, requiring manufacturers to prove their safety.
1984: the systemic autoimmune disease of a woman in the San Francisco area is found by a jury to be caused by her silicone breast implants. She is awarded $211,000 in compensatory damages and $1.5 million in punitive damages. the evidence is sealed by a court order.
In the years that follow, there is litigation all over the country alleging that breast implants caused various serious diseases and ailments.
In the end, and despite millions of dollars in payments to plaintiffs in class-action lawsuits and jury trials, scientists say they can find no cause-and-effect relationship.
June 1988: six years after the 1982 proposal, the FDA classifies breast implants as Class III.
December 1990: a program warning of silicone breast implant dangers runs on “Face to Face With Connie Chung.” also, a congressional hearing is held on the safety of silicone breast implants.
January 1992: the FDA’s commissioner, Dr. David Kessler, calls for a voluntary moratorium on the distribution or implantation of silicone breast implants until the FDA and the advisory panel have an opportunity to consider newly available information.
March 1992: Dow Corning, Bristol-Myers Squibb and Bioplasty exit the silicone breast implant business. McGhan and Mentor still manufacture breast implants. Dow sets up a fund for further research into breast implant safety.
April 1992: Kessler lifts the moratorium on silicone breast implants, but the only women allowed to receive implant surgery are those undergoing breast reconstruction. the recipients must be part of a scientific protocol.
March 1994: a class action suit is finalized by manufacturers; Dow Corning is the largest contributor. the other contributors include Baxter, Bristol-Myers Squibb/MEC, and 3M. It’s the largest class action settlement in history. but the manufacturers claim there is no scientific evidence linking silicone breast implants with autoimmune diseases.
June 1994: a Mayo Clinic epidemiologic study, published in the new England Journal of Medicine, finds no increased risk of connective-tissue disease and other disorders studied in women who had silicone implants.
1995: the American College of Rheumatology says there is “compelling” evidence that implants did not cause systemic disease.
May 1995: Dow Corning files for Chapter 11 bankruptcy. Dow is looking at 20,000 lawsuits, some with more than one plaintiff, and about 410,000 potential claims that have been filed in the settlement. the bankruptcy halts all litigation.
June 1995: the Harvard Nurses Epidemiologic Study is published in the new England Journal of Medicine. It finds no increased risk of connective-tissue disease in women with silicone implants.
December 1995: more than 20 studies and abstracts have come out in the U.S. and internationally, all failing to support a causal relationship between silicone implants and various autoimmune related illnesses.
August 1997: The new York Times says implant manufacturers have won 80 percent of cases against them. but a jury in the first class-action suit rules that Dow Chemical (which owns half of Dow Corning) deceived women by hiding safety information about the silicone in the implants.
September 1997: the Journal of the National Cancer Institute publishes a review of many medical studies that concludes breast implants do not cause breast cancer. the researchers describe evidence for linking implants to other diseases as “borderline.”
November 1998: Dow Corning files for bankruptcy reorganization, which includes a $3.2 billion, previously agreed-to settlement. People who filed claims are offered options: those who want to cash out immediately and not file a disease claim will be paid $2,000. that can be combined with $5,000 for implant removal and $20,000 for a ruptured implant. those who have already filed a disease claim will receive between $10,000 and $250,000.
June 1999: The Institute of Medicine, part of the National Academy of Sciences, releases a 400-page report by an independent committee of 13 scientists. They conclude that although silicone breast implants may be responsible for problems including hardening or scarring of breast tissue, the implants do not cause any major diseases such as lupus or rheumatoid arthritis.
2002: Dolly Parton admits to the news media that she has breast implants. through the years, many celebrities confirm getting them, too, including onetime Playboy Playmates and actresses Pamela Anderson and Jenny McCarthy; singer Victoria Beckham; TV personalities Denise Richards and Heidi Montag; and later, members of various casts of “The Real Housewives,” including Alexis Bellino, Vicki Gunvalson and Tamra Barney of Orange County (Barney recently had them removed) and Kim Zolciak of Atlanta.
2003: Mariel Hemingway talks about her experience with breast implants, saying the silicone leaked. “I think implants are bad news. I enjoyed them for about a year, then from ages 20 to 32, I was asking, ‘Why do I have these? I hate these.’”
October 2005: TV personality Sharon Osbourne admits to having had breast implants inserted earlier in the year. “I am a 34DD now and Ozzy loves them,” she said of her husband. She later swapped them out for more modest ones, and in 2011 said she had a complication in which one changed shape and leaked.
November 2006: the FDA allows silicone gel-filled breast implants back on the market but requires manufacturers to conduct follow-up studies to learn more about the long-term performance and safety of the devices. the FDA also states on its website: “Breast implants are not lifetime devices. the longer a woman has them, the more likely she is to have complications and need to have the implants removed or replaced. Women with breast implants will need to monitor their breasts for the rest of their lives.”
The site also says: “Studies to date do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, no study has been large enough or long enough to completely rule out these and other rare complications.
“FDA is working with the two manufacturers who make silicone gel-filled breast implants, Allergan and Mentor, to address the challenges in collecting follow-up data on the women who have received these implants.”
2010: Implants made with industrial-type silicone by French company PIP are banned. the implants were widely used across Europe and South America, and governments begin urging women to have them removed. (They are not sold in the U.S.)
March 2011: the FDA approves a new silicone-gel breast implant, making Sientra of Santa Barbara the third U.S. company to market the products, after Irvine-based Allergan and Johnson & Johnson’s Mentor unit.
May 2011: Casting in Miami for a new ’50s-era TV show, “Magic City,” is described as difficult because local women without breast implants are apparently in short supply.
Sources: The new York Times, the Associated Press, Food and Drug Administration, Bloomberg Business News, BBC News Magazine, the Guardian, “Inventing Beauty” by Teresa Riordan, “Frontline,” American Academy of Neurology, Medscape.com, Twoop.com
<a href="http://www.ocregister.com/articles/breast-354406-implants-silicone.htmltag:news.google.com,2005:cluster=http://www.ocregister.com/articles/breast-354406-implants-silicone.htmlWed, 16 May 2012 13:24:07 GMT”>Anniversary: 50 years of fake breasts
