Tag Archives: FDA

FDA: Breast Implants and Sperm Donors

Laurie says:

I’ve had my attention drawn recently to two important and very different body issues that involve the power and influence of the FDA. Their malign influence can certainly be blamed in part on the Bush administration. Mostly it seems like business as usual – commerce over health, the devaluation of women’s bodies and homophobia.

I received an email from Beth Katz at Our Bodies, Ourselves asking me to draw attention to this article “Are Breast Implants Absolutely Safe” in the Huffington Post.   The article includes very good information and personal stories on some of the serious risks of implants.

Carol Ciancutti-Leyva, director of the documentary “Absolutely Safe,” is the daughter of a cancer survivor. Her mother’s journey, from a double mastectomy to silicone implants in the early 70s – which resulted in chronic illness, formed the impetus for the film.

…The documentary came out in 2007, after a ten-year struggle for funding. It is currently being booked for screenings on college campuses and is being used in classrooms devoted to women’s studies, bioethics, and public policy.

Currently, Ciancutti-Leyva is working to create strategic partnerships to mobilize an “Informed Consent” campaign about the use of breast implant devices. Her model for legislation is a New York State Law (State of New York – Article 24-E, Section 2499w New York State law) that required the state’s Department of Health to publish a booklet that must be received by every woman considering a hysterectomy. It succinctly outlines risks, complications, alternative treatments, and recuperation expectations. Presently, the FDA has a guide on breast implants, but it is not legally mandated that prospective patients receive it. The “FDA Breast Implant Consumer Handbook” was published in 2004. Ciancutti-Leyva told me that the information reads as “a cautionary tale.”

…..Without question, future conversations about breast implants will have to do more than just scrutinize the medical uncertainties. The need for informed consent was addressed as far back as 2000, in an editorial appearing in the Fall issue of The Journal of the American Medical Women’s Association. Written by Nancy Neveloff Dubler, LLB and Anna Schissel, JD, it was entitled “Women, Breasts, and the Failure of Informed Consent.” The authors examined whether “informed consent for breast augmentation is too fragile a reed to withstand the storm of commerce.” Norrigan sees part of the push for “informed consent” starting with outreach to legislators and policy makers.

And Kurt Siegel pointed me to Libby Post at the Seattle Gay News for this post on the FDA and gay sperm donors.

The U.S. Food and Drug Administration’s soon-to-be-implemented guidelines about anonymous sperm donors present a reproductive-rights issue for both Gay men and Lesbians. When a government can’t directly stop undesirable people from reproducing, it simply makes it more difficult for them – in this case, by instituting a policy that is more politically motivated than it is rooted in science.

…Indeed, there were on record only a few cases of HIV transmission through infected donor sperm. (And today, there is no recorded increase of such transmission.) Happily, activists were successful at staving off the discriminatory change, but under Bush, the FDA began revisiting the idea in earnest.

…Let’s face it – the underlying premise of the FDA guidelines is that Gay men should not father children, although the agency doesn’t come right out and say that. It conveniently circumvents the charges of anti-Gay discrimination by noting that the guidelines don’t have the force of law, and that the agency’s official regulations – which do carry legal force – never use the words Gay or homosexual. Yet, as one sperm-bank director admitted to Gay blogger Michael Petrelis, “A lot of clinics will use the guidelines as an intimidation document and refuse Gay donors.” …

What’s more, the new guidelines also have a direct impact on Lesbian reproductive choice. Many Lesbian couples prefer Gay sperm donors. Indeed, they may have chosen a sperm bank where donors agree to have their identity revealed at some point in the future – usually when the child comes of age – and want that donor to be family in more ways than one.

Of course, the new FDA guidelines for sperm donors may seem benign compared to egregious examples from the women’s reproductive-rights movement. But the Lesbian and Gay community shouldn’t fool itself into complacency. The guidelines are ultimately all about who is and isn’t fit to parent – who is, in effect, mommy material, a phrase I coined a few years back. Now the FDA is poised to include Gay men – based on their sexual identity, not on the realities of their sexual behavior – under the rubric of those who aren’t daddy material.

Both of these posts are well worth reading.  Check them out!