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Are Silicone Breast Implants Really Safe? - Critics Remain Skeptical Despite Green Light from FDAJan 1, 2007 This past November, the Food and Drug Administration (FDA) lifted a 14-year ban on the cosmetic use of silicone breast implants. Women who are least 22 years old will now be able to opt for silicone implants for breast enhancement. This will be in addition to all women undergoing non-elective breast reconstruction.
Although the FDA has the final word on the subject, many health advocates staunchly oppose the agency’s decision because they still do not believe that silicone implants are safe. The critics argue that these products have not been updated or modified to remove the risks that caused the original ban thereby making the FDA’s action unjustified, illogical, and not in the public interest.
Silicone implants first entered the market more than 30 years ago and quickly became a popular method of breast enhancement. In 1992, however, the ban was put in place after many recipients reported pain, deformity and serious illness caused by ruptured or leaking implants.
At the time of the ban, the FDA argued that there was not enough data to prove that silicone implants were “safe and effective." Since the ban, the FDA has said that silicone implants are only to be used for women undergoing breast reconstruction following cancer surgery or trauma.
After the ban was imposed, thousands of women in the United States and elsewhere sued the manufacturers of silicone implants. This resulted in major class-action settlements by several companies including 3M, Baxter, Bristol-Myers, and Dow Corning. All of these companies subsequently shut down their production silicone breast implants.
In 1999, the Institute of Medicine, a branch of the National Academy of Sciences, stated that even though implants have the potential to rupture and become hard and painful, there was no definitive evidence that they were associated with serious diseases such as autoimmune disease or cancer.
In October 2003, FDA advisors recommended allowing the implants to be sold again but the agency overruled that recommendation.
Although the ban has been lifted, the FDA is requiring that manufacturers inform women that the implants are not “lifetime devices.” Recipients need to know that they will most likely need at least one additional surgery to remove or replace their implants.
The FDA has also instructed Mentor Corp. and Allergan Inc., manufacturers of silicone implants, to conduct an extensive study of at least 40,000 implant recipients over the course of the next ten years and provide the results to the government.
Last year, implants filled with a saline solution (basically saltwater) were used in lieu of the silicone products in more than 264,000 women. Medical experts predict that the use of silicone implants will now significantly increase since silicone-gel implants are considered to be softer and to have a more natural appearance. Thus, silicone implants are predicted to again become a popular option for women undergoing both cosmetic and reconstructive surgery.
In a statement, Michael Ball, president of Allergan, said that "science has prevailed here" and added: "The FDA set an extremely high bar for approval...There's a huge body of scientific data there." He also said that the worldwide market for breast implants, which is currently more than $540 million annually, will now start to grow more rapidly.
Critics, however, were openly disappointed and even appalled by the FDA's turnabout. Diana Zuckerman, president of the National Research Center for Women and Families who has worked on breast implant safety issues for over 15 years, said the approval was not based on scientific research but was rather the product of corporate lobbying.
Zuckerman argues that there is still not enough information about the long-term health risks of the implants. Furthermore, the information that is actually known is not good. Studies have shown that some women will experience negative effects such as joint pain, chronic fatigue, and leakage.
While some researchers have argued that leaking silicone implants can lead to autoimmune diseases or cancer, the National Academy of Sciences' Institute of Medicine reviewed many studie
s and concluded that there was no convincing evidence of this connection. Less severe complications, however, were common and undeniable.
In a study of 907 Alabama women with silicone implants, one-third reported they had at least one operation to remove or replace the devices. Among 344 who underwent MRI scans to examine the state of their implants, 69 percent experienced rupture of at least one implant.
A spokesman for Mentor said the company will replace all leaking or ruptured implants, which cost $800 to $950 each. It will also pick up $1,200 of the $8,000 cost of an additional operation in the five years after an implant is put in.
Of course, this type of voluntary remedial practice reflects nothing more than an operating cost associated with a very lucrative commercial product. It neither insures nor vouches for the safety of the implants. In fact, in its own way, it acknowledges (at the very least) the existence of a failure rate that, in most other industries or other medical devices, would be unacceptable.
Health insurers, however, are unlikely to reimburse policyholders for breast implantation performed for purely cosmetic reasons. This will leave women opting for such breast enhancement to pay tens of thousands of dollars for the initial implantation surgery, regular MRI screenings to ensure that the devices are not leaking, and for replacement surgery, which is highly probable at some point.
Susan F. Wood, who served five years as the FDA's top official for women's health, said she was disappointed by the approval because she does not believe there is adequate data to demonstrate that the implants are safe. She argued that is it imperative that the FDA require the companies to conduct the planned long-term studies of the implants.
"Given that the approval has gone through, we have to insist on getting adequate information for both patients and surgeons so that we ultimately will know whether or not these are products that women should be using," said Wood.
Amy Allina, program director at the National Women’s Health Network, criticized the decision, saying that the FDA had lifted the ban on silicone implants despite the fact that the manufacturers failed to answer basic safety questions about their product, such as exactly how long implants would last without rupturing, and the potential health effects that could occur if the silicone leaked out of the implant and spread to other parts of the body.
Allina also argued that the companies will use a strategic marketing campaign to convince women that silicone implants are indeed safe. Furthermore, the FDA’s removal of the ban might inadvertently cause women to think that these implants are now safer than before.
Dr. Scott L. Spear, the chief of plastic surgery at Georgetown University, who has conducted clinical research for Allergan of Irvine, Calif., argues that the devices have been improved since they were banned in 1992.
“The shells themselves are made of different materials, a barrier shell, that is relatively much more impermeable,” Dr. Spear said. “The shells are thicker than in ‘91, much thicker than they were in earlier generations. The material inside is more cohesive, the stuff tends to stick together.”
While breast implants have grown in popularity for augmentation over the past 5 years, the popularity of breast implants for reconstructive surgery actually shrank. Last year, 291,000 women in the United States received breast implants for augmentation while 39,000 women had their implants removed.
Although the ban has been lifted, the FDA is still warning prospective users of silicone implants to consider the risks involved. For example, many of the changes to a woman's breast following implantation are irreversible.
The FDA also reminded women that the rupture of a silicone implant is usually silent, which means that often neither the woman nor her surgeon will know that her implants have ruptured. The FDA recommends that a woman should have her first MRI three years after her initial implant surgery and then every two years thereafter. The cost of these continued MRI screenings may exceed the cost of the initial surgery over the course of a lifetime and will likely not be covered by medical insurance.
Sidney Wolfe of Public Citizen, a highly respected consumer advocate and a longtime critic of silicone implants, called them "the most defective medical device FDA has ever approved." This apparently remains to be seen as the FDA gives silicone implants another try. Longitudinal studies of some of the original recipients from 1962 to 1992 will also help the FDA and health advocacy groups determine once and for all whether these products should stay or go.
Unfortunately, as in many other situations involving pharmaceutical products and medical devices, unsuspecting members of the public will be the guinea pigs used to make that determination.
If you believe silicone breast implants have injured you or a loved one, or if one the devices has failed or proven to be defective, please contact Parker Waichman LLP at yourlawyer.com for a free and thorough consultation. As always, if you believe you or a loved one has suffered an injury (physical or financial) as a result of the negligence, professional malpractice, fraud, or intentional act of another person, company, or municipality, our team of qualified attorneys will be glad to discuss the situation with you.